From Pilot to Portfolio: Scaling Circular Packaging
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From Pilot to Portfolio: Scaling Circular Packaging

We have seen plenty of circular packaging pilots that work in isolation.

A new design that’s more recyclable. An increase in recycled content. A workable deposit return trial that performs well in-store. A positive refill system experiment with a strong story behind it.

Then they stall

Not because the intent was wrong, but because pilots sit outside the full operating system and true commercial pressures. They are rightly protected from the cost, infrastructure, and commercial realities to test and learn consumer behavior, but are often ill-equipped to adapt for scale.

That is why packaging Extended Producer Responsibility (EPR) matters, as this is a scale-centric challenge.

It shifts packaging from a waste topic to a design and business topic. The Organisation for Economic Co-operation and Development (OECD), describes EPR as a policy approach that makes producers responsible through the post-consumer stage, while also generating funding and information for collection, sorting, and recycling systems. And the policy context is no longer theoretical. In the EU, the PPWR entered into force on February 11, 2025, and generally applies from August 12, 2026. In the UK, obligated producers must register, report packaging data, and pay fees. Australia is reforming packaging regulation to align packaging with circular economy principles. Ontario completed its transition to full producer responsibility on January 1, 2026. Canada expects packaging EPR for packaging in most, if not all, provinces and territories by 2030.

So the question is no longer whether circular packaging should be scaled.

The more useful question is this: will compliance effort be treated as a cost of doing business, or used as a lens for sharper portfolio choices?

Because as EPR becomes a reality, companies are forced to define things that pilots can leave vague or don’t answer. Which end-of-life pathway is realistic in each market? How likely is collection and effective sorting in normal conditions? Where is packaging complexity creating cost without improving recovery? Those are not paperwork questions. They are design questions, procurement questions, and portfolio questions. This is why EPR is better understood as a portfolio lens than a pilot trigger. Pilots still matter. They are often essential for testing formats, claims, and consumer participation models. But pilots alone do not tell you how a portfolio performs across geographies, channels, suppliers, materials, and recovery systems. That wider view is where scale is won or lost.

Pilots often succeed because they benefit from exceptional conditions. One geography. One retail partner. One highly engaged consumer group. One supplier willing to stretch. One team willing to intervene when reality gets messy. In some cases, even supportive national policy environments, such as France’s emerging regulatory push on reuse and refill under its circular economy legislation, can effectively act as a scaled, semi-controlled test bed.

Portfolios operate under normal conditions. They carry multiple markets, multiple channels, multiple suppliers, competing cost pressures, and uneven infrastructure. At that scale, the test is not whether a packaging idea worked once. The test is whether it still works when it becomes business as usual.

EPR also brings consumer behavior into focus. Packaging systems only work when people can participate in them. If organizations say they are consumer-centered, this is where that claim has to show up. Legislation should be used not just to meet regulatory requirements, but to design packaging experiences that are intuitive, low-friction, and aligned with everyday behavior. Disposal instructions need to be clear. Return and refill participation needs to feel intuitive. Sorting needs to work in ordinary households, not just in ideal conditions. Get this right, and you improve more than recovery. You reduce contamination, lower fee exposure, and strengthen the overall product experience.  Regulations will then not only encourage circularity, but they create a purposeful moment of action and innovation for companies to strengthen brand trust, delivering tangible value to consumers as well as the business. In other words, EPR can turn circularity from a pilot activity into an operating model that also improves the consumers’ experience, if companies use the opportunity.

Circularity has always been a system design challenge, and EPR is accelerating this advancement. The task is not simply to improve one pack in isolation. It is to understand how material choice, format, infrastructure compatibility, consumer participation, evidence burden, fee exposure, and end market reality interact. That is a different level of discipline, and it tends to expose weaknesses quickly.

A portfolio view allows better questions. Which formats create the highest compliance and cost exposure? Which packs have the weakest real-world recovery pathway? Which material choices add complexity without improving the outcome? Where can harmonization reduce cost and improve recyclability? Which claims are robust, and which are vulnerable? Where could redesign create both environmental gain and economic value?

The strongest companies will not treat EPR as a layer of administration added to yesterday’s packaging choices. They will use it to redesign how those choices are made. In practice, that means defining end-of-life pathways in operational terms, separating what can be standardized globally from what must be adapted locally, evaluating packs with a balanced scorecard rather than a single metric, testing behavior honestly, building the evidence plan early, and staging change across the portfolio where learning is fastest and risk is lowest.

Handled tactically, EPR will bring short-term pain with few long-term gains. Handled strategically, it should shape and accelerate the decisions you ultimately need to make to protect your future.

As part of a strategy, it can become a source of commercial advantage. Not because regulation is inherently beneficial to producers. It is not. But because it can force the level of scrutiny, many organizations have postponed. That scrutiny can lead to fewer problematic formats, better alignment between design and infrastructure, lower material intensity, stronger claims, smarter use of recycled content, and clearer investment cases for reuse, refill, or redesign where those moves are genuinely viable.

The companies most likely to create value from packaging EPR will be the ones that use that pressure to review the portfolio properly and scale the changes that actually work.

At Cambridge Design Partnership, we help teams translate regulatory changes to practical design and engineering action. That means identifying where recovery pathways are weak, where behavioral assumptions are unrealistic, where evidence requirements need to shape the brief earlier, and where material and format decisions are creating hidden risk. Typically, that means combining circular diagnostic work, sustainability screening, Sustainability Clean sheeting, human-centered design, engineering validation, and regulatory readiness into a single decision process.

It’s worth asking one final question. Are you only preparing to comply, or are you using this moment to reshape the portfolio for a more circular and commercially resilient future?

 

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Sustainable pharmaceutical packaging without compromising safety or usability

When people talk about “sustainable packaging,” they often picture quick material swaps and bold recyclability claims. But in pharmaceuticals, it’s rarely that simple.

Pharma packaging is a safety-critical system. It protects sensitive formulations, supports regulatory compliance, and helps patients take the right medicine in the right way, every time.

That’s why packaging teams are under a different kind of pressure: they are being asked to reduce environmental impact while holding the line on performance, patient safety, and supply resilience.

At Cambridge Design Partnership (CDP), we work with pharma and healthcare teams to make that trade space manageable. The goal isn’t sustainability as a side project. It’s packaging decisions that are evidence-led, patient-centered, and durable under regulatory scrutiny.

The structural tension at the heart of pharmaceutical packaging

In practice, pharmaceutical packaging exists inside tight constraints that are in place for good reason:

  • Validated moisture, oxygen, and light barriers (often with narrow stability margins)
  • Strict control of chemical interactions and leachables across materials, inks, adhesives, and coatings
  • Tamper evidence, traceability, and serialization requirements
  • Repeatable, audited manufacturing processes with controlled change management
  • Global regulatory alignment, long shelf-life assurance, long qualification cycles, and post-approval variation burden

However, here is another non-negotiable that is often underweighted in sustainability conversations: patient usability.

In effect, packaging is the interface between medicine and the person using it. It must enable patients to identify the correct drug clearly, complete any necessary inspection (for example, tamper evidence, integrity, or visual checks, where relevant), and access the drug product reliably. If a sustainability change makes a pack harder to open, harder to read, or easier to confuse, it creates a risk that overwhelms the environmental benefit.

As a result, progress is rarely about a single material substitution. Sustainable outcomes come from system decisions – barrier, labeling, usability, manufacturing, logistics, and end-of-life considered together.

Why the pressure is now unavoidable

1. Regulation is becoming a market access issue.

In Europe, the PPWR (Packaging and Packaging Waste Regulation) is now the anchor regime: it entered into force in February 2025 and will apply from August 2026, with recyclability tightening through 2030 and a formal review horizon in 2035 that is explicitly relevant to certain pharma pack exemptions. Here, the key challenge is timing: regulatory clocks move faster than pharma packaging platforms can change.

2. Stakeholder expectations are rising.

At the same time, payers, providers, investors, and patients increasingly expect credible action. Packaging is visible, measurable, and easy to compare – so it’s becoming a practical test of seriousness, not a marketing footnote.

3. The business case is shifting from “nice to have” to “must manage”.

Consequently, packaging decisions now touch cost, resilience, and speed to market: material exposure, waste fees, supply fragility, and late-stage redesign risk. In most cases, getting ahead of change is usually cheaper than reacting when options are already locked.

What we see in real programs

A few patterns show up repeatedly when teams try to move from intent to execution.

The biggest wins aren’t always in the primary pack.
In many cases, primary packaging can be the hardest part of the system to change quickly. By contrast, secondary and tertiary packaging (such as cartons, leaflets, protective elements, and shipping formats) often provide faster, lower-risk opportunities – especially when you design them to reduce total material use, improve transport efficiency, and avoid formats that create sorting and recycling problems.

“Recyclable” is not the same as “safe, compliant, and used correctly.”
For pharma, the right question is usually: What is the lowest-impact design that still delivers stability, compliance, and patient usability? That framing prevents false optimization.

Late redesign is the hidden cost.
When sustainability is added after packaging architecture decisions are made, you end up negotiating against a nearly fixed design. That’s when cost and time blow out – and when risk rises.

A practical framework for executive decision-making

If you’re leading packaging strategy, the most useful step is to turn sustainability into a structured decision process rather than a series of ad hoc requests. Here’s a framework we use with teams to keep work focused and defensible.

1. Define your non-negotiables up front

  • Before exploring options, align on what cannot be compromised:
  • Patient safety and correct use
  • Readability and differentiation (right medicine, strength, dose, expiration)
  • Access and openability under real-world conditions
  • Barrier performance and shelf-life confidence
  • Tamper evidence and traceability requirements
  • Validated manufacturing performance and supply resilience

This avoids “optimizing” a pack into something that fails in the field.

2. Establish a credible baseline, quickly

You don’t need a year-long study to find direction. A focused baseline – material flows, key pack components, manufacturing yield sensitivity, logistics assumptions, and end-of-life reality – usually reveals where the impact sits and where it doesn’t.

This is where we often apply lifecycle thinking and our Sustainability Cleansheet method: Quantify the big cost and environmental impact drivers early so you don’t spend months improving the wrong thing.

3. Build a short list of options and stress-test the tradeoffs

For each option, teams should be able to answer clearly:

  • What changes physically? (materials, structure, labels, coatings, inks, adhesives)
  • What risks move? (stability margin, E&L, usability, line performance, supply continuity)
  • What improves? (impact reduction, cost, simplification, waste reduction, data/traceability)
  • What evidence is needed? (bench tests, line trials, stability, human factors validation)

The aim is not perfect certainty. It’s the early elimination of weak options and disciplined focus on the few options that can scale.

4. Pilot to reduce uncertainty, not to signal virtue

In pharma, pilots only matter if they answer hard questions: manufacturability, patient behavior, stability confidence, and real end-of-life outcomes (not just theoretical recyclability).

We design pilots to generate decision-grade evidence, so teams can commit without gambling.

5. Use “smart print” technologies thoughtfully

Many teams want digital capability – traceability, anti-counterfeit protection, patient guidance, or better sorting instructions – without turning packaging into electronics.

That’s where smart print technologies can help: Printed features (from advanced QR codes and variable data to printed conductive inks and thin printed circuits) can deliver “DPP-style” benefits – linking the pack to verified product data, instructions, and chain-of-custody information – without adding bulky components.

But they still require end-of-life thinking. Even small amounts of conductive ink or functional layers can affect recycling behavior and material recovery if they’re used indiscriminately. The practical approach is:

  • Keep digital features as light as possible (often secondary packaging is the right home)
  • Avoid designs that contaminate or complicate recycling streams
  • Choose materials and inks with recovery pathways, where available
  • Be explicit about the end-of-life intent, not just the in-use feature set

Smart features can support compliance and patient outcomes – but only if they’re designed as part of the packaging system, not bolted on.

6. Build a roadmap that matches pharma timelines

Packaging change in pharma is slow by design: qualification, validation, supplier readiness, and stability programs all take time. That’s exactly why the gap between product development cycles and regulatory timelines matters. The right roadmap staggers effort:

  • Near term: Secondary and tertiary improvements and material reduction
  • Mid term: Architecture changes where stability risk is manageable
  • Long term: Platform shifts and primary packaging strategies aligned to the next regulatory horizon

How CDP helps

Clients bring us in when they need momentum without compromising on safety. What makes CDP different is the way we connect the disciplines that usually sit apart:

The result is packaging strategy that holds up: Lower-impact solutions that are still manufacturable, compliant, and usable – built on evidence rather than hope.

The opportunity

Sustainable pharmaceutical packaging isn’t about copying approaches from consumer goods. It’s about designing within the constraints that matter – stability, safety, usability, and supply assurance – while still making real progress on impact.

If you’re responsible for packaging strategy and you’re facing tighter timelines, rising expectations, and harder tradeoffs, we can help you move faster with confidence.

Connect with CDP

For more on how to accelerate meaningful innovation in sustainable pharmaceutical packaging, contact Cambridge Design Partnership.

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Precision Delivery: The Missing Link In Cell & Gene Therapy

Featured in ONdrugDelivery News, Jessica Alzamora, Dr Karla Sanchez and Emily Chang discuss the necessity for precision when delivering cell and gene therapies, explore how this precision can be designed and demonstrated, then go on to describe how a minimum viable product approach to device development can act as a strong predictor of a successful drug delivery device.

Cell and gene therapies (CGTs) are at the forefront of precision medicine, with the potential to repair or replace faulty genes and cells to treat disease at its biological source. Despite this promise, the success of CGTs depends on one defining factor: precision. Every stage, from designing a vector to delivering it in the body, demands careful control to ensure that the treatment reaches the targeted region and/or cells, at the right dose and with minimal off-target effects (Figure 1).

 

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Figure 1: Commonly targeted delivery sites for CGTs.

A clear example of this reliance on precision comes from a currently available gene therapy to help improve functional vision in patients with an inherited retinal disease due to a genetic mutation. The approved adeno-associated virus 2 (AAV2) gene therapy Luxturna® (voretigene neparvovec, Spark Therapeutics, Philadelphia, PA, US) must be delivered via a highly targeted subretinal injection to ensure that the therapy reaches and acts on the exact layer of cells needed for vision. Even small variations in injection depth or placement can change how effectively it restores function, and incorrect placement can increase the risk of inflammation.1 This shows that the success of a therapy depends as much on how it is delivered as what it delivers – the therapeutic effect is dependent on the accuracy of the delivery modality.

To unlock the full potential of CGTs, the industry must not only consider molecular innovation but also focus equally on the method of precision delivery to expand the pivotal link between discovery and patient benefit. Achieving reproducible precision will determine how effectively these breakthroughs translate from rare success stories into accessible, scalable therapies.

This shows that the success of a therapy depends as much on how it is delivered as what it delivers – the therapeutic effect is dependent on the accuracy of the delivery modality.

Where Precision Matters Most In CGTs

CGTs are not produced in the same way as small molecules or standard biologics. Many programmes are patient-specific or produced in small, labour-intensive batches, with customised biomanufacturing and strict cold chain to preserve vector integrity or cell viability. These constraints make products extremely costly: Luxturna®, for example, is priced at around US$850,000 (£650,000) per patient.2 Given the resource-intensive nature of producing usable material, development teams must prioritise process efficiency and precision from the earliest stages of production.

Potency and safety are also tightly linked. Small deviations in target delivery or poor biodistribution control can provoke serious immune-mediated toxicities,3 among other serious side effects, which is particularly true in gene therapies.4 For instance, intrathecal delivery (administration into the cerebrospinal fluid, e.g. via lumbar injection, allowing direct access to the central nervous system) can have a biodistribution-associated risk that results in dorsal root ganglion inflammation and neuronal degeneration, particularly with higher doses, where neither the therapy’s tropism (affinity with specific cells) nor cerebrospinal fluid dynamics have been fully characterised.4

“Precision in where and how therapies are delivered determines how safely it can be dosed, how consistently it can be scaled and how much product is needed to achieve a therapeutic effect.”

Some therapies may only succeed when they are placed with millimetre-scale accuracy. For a rare neurological disorder called aromatic L-amino acid decarboxylase deficiency, the AAV2-based therapy Upstaza™ (eladocagene exuparvovec, PTC Therapeutics, Warren, NJ, US), is delivered through stereotactic neurosurgery, which delivers four small infusions into the putamen in a single session (two per hemisphere).5 The product label specifies the route, infusion sites and dosing parameters, as the efficacy of the therapy depends on reaching the correct brain region while avoiding wider systemic exposure. This is precision delivery built directly into the treatment’s design. Furthermore, for one-off or single-administration gene therapies, re-delivery may not be possible (e.g. due to pre-existing antibodies to AAV) or may be considered too risky to conduct (e.g. direct-to-brain administration).

Precision in where and how therapies are delivered determines how safely it can be dosed, how consistently it can be scaled and how much product is needed to achieve a therapeutic effect.

When Precision Becomes A Moving Target

Precision is easy to define, in theory, but difficult to achieve in practice. For many CGTs, location, distribution and dose must be defined long before clinical trials begin, yet each is influenced by complex and patient-specific variables (Figure 2). Precision is less critical for ex vivo approaches, such as chimeric antigen receptor T-cell therapies, where cells are modified outside of the body prior to intravenous administration. These treatments have demonstrated success, as seen with Kymriah® (tisagenlecleucel, Novartis) and Yescarta® (axicabtagene ciloleucel, Kite Pharma, Santa Monica, CA, US) in haematological malignancies. In contrast, precision becomes far more consequential for in vivo gene and stem cell therapies. What seems simple – such as targeting a specific organ for a rare disease – quickly becomes challenging when teams must decide what level of precision is sufficient in terms of which part of the organ and its diverse cell populations to target for the therapy to be effective.

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Figure 2: Achieving the correct location, dose and distribution.

Location

This challenge is clearly visible in liver-directed AAV therapies, where defining location goes beyond reaching the organ itself. The liver’s intricate vasculature and cell diversity means that vector access and expression vary widely, while efficacy depends on transducing enough hepatocytes without excessive uptake by other cells that may trigger immune responses or reduce potency.6 Achieving this balance relies on optimising the route of administration, delivery site and dose flow control.

Distribution

Parameters such as vector concentration, infusion rate and device (e.g. cannula) geometry determine how the therapy is distributed through the tissue and how reliably it reaches target cells. To manage these interdependencies, computational and experimental modelling are integral throughout development of the therapy and delivery device. By modelling vector flow, convection and uptake in patient-specific anatomy, device developers can predict how a formulation or delivery approach will behave before starting animal studies, or they can refine it alongside these studies. These models enable the integrated team (composed of formulation/modality specialists, device developers and more) to optimise distribution patterns, reduce experimental uncertainty and accelerate iteration, allowing precise delivery to be engineered rather than inferred.

Dose

A clearer understanding of anatomical location and distribution also improves how the team defines and manages dose precision, which ultimately determines efficacy and safety. Dosing CGTs is about far more than volume; it reflects how much active vector or number/type of cells are needed to ensure the desired effect within the target tissue. Achieving precise dosages means controlling both potency and delivery conditions so that the administered quantity can translate into a safe and effective treatment. Advances in data analytics (e.g. vector analysis), flow-controlled infusion and real-time delivery monitoring are helping to define this relationship more accurately, enabling teams to move from empirical dose escalation to evidence-based dose design.

Although device design cannot completely negate biological variability, it can stabilise the physical conditions of delivery in terms of location flow and distribution, reducing the influence of external factors on therapeutic performance. In this sense, delivery systems are an integral and essential part of the therapy’s design; the therapeutic without the device is useless. A minimum viable product (MVP) delivery device is essential even in early-stage therapy development, as it underpins both the predictability and scalability of clinical outcomes, as well as reducing risk to both the patient and therapy programme.

How To Demonstrate Precision

If defining precision is difficult, demonstrating it under clinical conditions is even harder. Many CGTs show encouraging results in modelling and in vitro studies, only to encounter unexpected variability once tested in animals or humans. Translating a theoretical understanding of location, dose and delivery pattern into reproducible, in vivo performance remains one of the toughest challenges in the field.

The difficulty often emerges during the transition from therapeutic discovery to device-specific preclinical testing. Early studies may demonstrate vector bioavailability or device function separately, focusing on establishing foundational performance characteristics; however, this separation can limit understanding of how the two interact under physiological conditions. As a result, the first time the full system is tested, typically in animal models, teams may struggle to interpret poor outcomes. The question being: is the issue with the therapy itself or with how it was delivered?

If the delivery device or route is not well characterised before entering in vivo preclinical work, study design, surgical procedures and even success criteria can become ambiguous or have a lack of reproducibility.

Study Design

Preclinical study design therefore becomes the first true test of precision. The chosen route of administration determines not only how the therapy will be delivered, but also which model is appropriate for advancing an MVP approach to device design that supports overall therapy development. For example, a device that matches the therapy development stage and its requirements allows for evidence gathering on the control of delivery – isolating results for therapeutic effectiveness.

Anatomical and physiological differences, particularly in vascular structure, tissue density or organ size, mean that delivery parameters optimised in animals may not translate directly to humans. Building these constraints into the study design early on can help teams interpret results with greater confidence.

Procedural Control

Demonstrating precision also depends on procedural control. Every step, from therapy preparation and handling to administration and post-delivery care, can influence efficacy. For cell therapies, cell sedimentation during preparation or delays between thawing and delivery can alter dose consistency and viability. For gene therapies, infusion rate, device placement and user variability can all shift distribution patterns. Integrating human factors engineering into device and protocol design using procedural expertise helps to standardise these steps, thus improving reproducibility and safety.

Regulatory Scrutiny

Ultimately, preclinical and clinical studies are where precision delivery meets regulatory scrutiny. Demonstrating that a therapy and its delivery system consistently achieve targeted exposure is essential for proving both safety and efficacy. Without an early integrated approach to development of the device, formulation and route of administration, teams risk employing complex and expensive animal models or clinical studies only to discover that the delivery method itself limits their ability to assess therapeutic potential.

Incorporating delivery design and evaluation early in development is therefore not just good engineering – it is a strategic safeguard. Precision that is defined, engineered and tested in parallel with the therapy dramatically increases the chances of reproducible success in the clinic.

Conclusion: Precision Delivery Is The Next Frontier

The future of CGTs will not be defined solely by novel vectors or manufacturing breakthroughs, but by the industry’s ability to deliver these therapies with accuracy and consistency at scale. As CGTs move towards broader indications, the need for predictable, accessible delivery will only intensify. Achieving precision demands earlier integration of biological, engineering and human factors design, alongside continued investment in modelling and device innovation. Precision delivery bridges the gap between discovery and patient impact, turning theoretical efficacy into real-world benefit.

The lesson is clear: precision delivery is not a supporting technology, but the missing link that will connect scientific ingenuity with clinical and commercial success. Those who master it will define the next era of CGTs.

“The future of CGTs will not be defined solely by novel vectors or manufacturing breakthroughs, but by the industry’s ability to deliver these therapies with accuracy and consistency at scale.”

References
  1. Patel MJ et al, “Surgical Approaches to Retinal Gene Therapy: 2025 Update”. Bioengineering, 2025, Vol 12(10), art 1122.
  2. “Spark’s gene therapy price tag: $850,000”. News Article, Nature Biotech, Feb 6, 2018.
  3. Morris EC, Neelapu SS, Giavridis T & Sadelain M, “Cytokine release syndrome and associated neurotoxicity in cancer immunotherapy”. Nature Rev Immunol, 2022, Vol 22(2), pp 85–96.
  4. Perez BA et al, “Management of Neuroinflammatory Responses to AAV-Mediated Gene Therapies for Neurodegenerative Diseases”. Brain Sci, 2020, Vol 10(2), art 119.
  5. “Upstaza (eladocagene exuparvovec)”. Web Page, EU EMA, accessed November 2025.
  6. Cao D et al, “Innate Immune Sensing of Adeno-Associated Virus Vectors”. Hum Gene Ther, 2024, Vol 35(13–14), pp 451–463.

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This article highlights how the right device can turn complex two-component injectables into simple, safe, and accessible treatments. If you’re exploring delivery challenges or want to design patient-friendly solutions for advanced formulations, we’d love to talk.

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Drug Delivery to the Brain: Engineering Precision Across Novel Modalities

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Neurodegenerative diseases such as Alzheimer’s disease (AD), Parkinson’s disease (PD), motor neuron disease (MND, including amyotrophic lateral sclerosis, (ALS)), and frontotemporal dementia (FTD) remain areas with limited disease-modifying treatments. Therapeutic pipelines in this area are increasingly dominated by antisense oligonucleotides (ASOs), RNA interference (RNAi) molecules, monoclonal antibodies, and viral gene therapies such as adeno-associated virus (AAV). These modalities offer the potential to modulate genetic pathways, reduce toxic proteins, or deliver genes to modulate disease pathways.

However, the size, structure, and physicochemical properties of these modalities largely prevent them from crossing the blood–brain barrier (BBB) through systemic delivery routes. The brain’s protective architecture restricts where and how these molecules can be delivered, and their complexity introduces delivery demands that conventional administration cannot meet.

Drug development must therefore evolve in parallel with delivery system design.

Once a modality is defined, the delivery strategy and device architecture required to administer it safely, precisely and effectively must be developed alongside it.

Why New Modalities Require Bespoke Approach to Delivery

Many of the emerging central nervous system (CNS) modalities have delivery requirements that differ fundamentally from traditional therapeutics. ASOs and RNAi therapeutics, for example, require broad CNS exposure and are therefore commonly administered into the cerebrospinal fluid (CSF) rather than via more localised, parenchymal approaches. CSF flow is largely pulsatile and oscillatory, with a slow net movement along the spine. After lumbar intrathecal administration, for example, these transport dynamics together with limited diffusion and tissue uptake, usually cause the drug to stay concentrated near the injection site and to decrease progressively as it travels upward towards the brain. Because these molecules are highly charged and diffuse slowly, such gradients persist, limiting penetration into deep structures without controlled flow. Device requirements should therefore include precise catheter placement, controlled infusion, prevention of local pooling, and repeat dosing capability.

In contrast, large proteins such as monoclonal antibodies must reach cortical, subcortical, or deep-brain regions, necessitating intracerebroventricular or intraparenchymal delivery. Devices must incorporate many elements to ensure targeted delivery such as reflux-resistant geometries, strategies for targeted spatial coverage, controlled infusion profiles, and low-adsorption materials to prevent protein aggregation.

Viral gene therapies impose some of the strictest demands on delivery systems. AAV vectors are sensitive to shear forces, turbulence, surface adsorption, and pressure changes, and maintaining capsid integrity throughout preparation and infusion is critical. Delivery systems must include ultra-smooth internal surfaces, gentle and stable low flow rates, inert materials, and high-precision targeting of deep structures.

In these cases, the delivery device becomes an integral component of the therapeutic product.

Device Engineering as a Core Component of Drug Development

When delivery impacts therapeutic efficacy, the device effectively becomes part of the therapy. The mechanical, geometric, and material requirements of a delivery system must therefore be defined not only by clinical considerations, but by the physical and biological behaviour of the therapeutic agent and the tissue it enters. In the CNS, this means accounting for the poroelastic nature of brain tissue, how it deforms, absorbs, dissipates, and redistributes fluid under pressure. These properties vary markedly between grey and white matter, differ across deep nuclei and cortical layers, and evolve dynamically as disease alters cellular composition, extracellular matrix structure, and hydraulic resistance. Such heterogeneity means that a device designed for one anatomical context may not perform predictably in another, even at identical infusion parameters.

Because these biological factors directly shape how infusate spreads, engineers must design delivery systems around the interplay between modality constraints and tissue mechanics. This shifts the focus from simply handling the molecule to engineering the conditions under which it travels. Cannula-based systems, for example, are one way of addressing this focus and key decisions include selecting tip geometries that balance mechanical stability with minimal insertion trauma; choosing port architectures that control local flow vectors and prevent jetting or backflow; and tuning lumen dimensions and surface properties to reduce adsorption, shear-induced degradation, or clogging under clinically relevant conditions. Each of these choices dictates how the therapeutic is introduced into the tissue microenvironment and how reliably it follows intended distribution pathways.

Beyond the insertion device itself, infusion strategy becomes a critical engineering parameter in its own right. Flow rate, pressure control, and infusion timing must be optimised to avoid exceeding the tissue’s capacity to deform safely, a threshold that varies with pathology, age, and regional structure. In some contexts, a constant-pressure approach stabilises the infusion front, while in others, constant-flow allows more predictable volumetric spread. Incorporating features such as pressure-relief paths, multiport configurations, or dynamic flow modulation can further tailor distribution when a single port or monotonous flow profile is insufficient. The device, in other words, does not merely deliver the therapy, it shapes how the therapy propagates through complex biological substrates.

Thus, the therapeutic modality defines the device’s safe and effective operating window, from acceptable flow ranges to port geometry and infusion timing.

Integrating these constraints into device architecture is what converts a therapeutic concept into a deliverable intervention, shaping dosing, distribution, and clinical performance. This perspective anchors the subsequent design decisions and highlights why device engineering must evolve in parallel with emerging therapeutic modalities.

Research and Modelling: Validating Drug–Device Interaction

Ensuring a therapy reaches the right place (and not off-target), in the right amount, requires evidence. That evidence comes from a spectrum of approaches. In-silico modelling is often the first step, using first-principles physics, computational fluid dynamics, or finite-element methods to explore how a device, a therapeutic, and the brain’s microstructure interact. These models account for tissue porosity, elasticity, white–grey matter boundaries, fluids viscosity and dynamics, and pressure gradients to forecast how an infusion will spread before a single experiment is run.

But simulations are only as good as the worlds we build for them. Brain-mimicking hydrogels and 3D-printed phantoms provide physical testbeds where model-based predictions are challenged and refined. They make flow visible, enable rapid parameter testing, and allow researchers to probe failure modes without the constraints of animal work. These platforms narrow uncertainty and help translate computational insights into practical infusion parameters, helping guide device design.

Animal studies deliver the critical translational step, revealing how elements such as distribution, tissue response, device–tissue mechanics, and (for gene therapies) transgene expression play out in vivo. Here, the goal is not just to confirm spread, but to understand how biology responds to the physical act of delivery, a dimension no model or phantom can fully capture.

Together, these stages form an iterative design–test–refine loop, which is essential for reliable, modality-specific CNS delivery.

Collaborative Expertise and Scientific Frameworks

Because device-based delivery is integral to being able to achieve therapeutic effect of these modalities, progress depends on teams that can bridge biology, engineering, modelling, and clinical practice. Each discipline contributes a different piece: drug discovery teams define the therapeutic goal and target exposure; engineers translate those needs into device and flow-system architectures; modellers anticipate how an infusion will behave in complex tissue or fluid; neurosurgeons test procedural feasibility and targeting; imaging specialists verify where the therapy actually goes; and human factors experts ensure the device can be used safely and reliably in real clinical settings. Innovation emerges at the intersections of these disciplines, where insights are shared and refined.

To support this, many organisations draw on multidisciplinary scientific advisory boards (SABs) that span neurodegeneration, biomaterials, computational modelling, device engineering, neurosurgery, and regulatory science.

These boards provide an early-warning system for delivery challenges, shaping designs and validation strategies and ensuring that device performance stays aligned with biological and clinical requirements.

Complementing this are pre-competitive collaborations, modelling consortia, shared phantom libraries, device-testing networks, and harmonised imaging datasets, that give teams a common scientific language. These shared resources reduce duplication, improve reliability, and accelerate the path from concept to clinically deployable delivery systems.

Conclusion

Novel modalities, including ASOs, RNAi agents, antibodies, and viral gene therapies, represent the leading edge of neurodegenerative therapeutic innovation. But realising their full potential depends on delivery systems that are precise, reliable, and tailored to each modality’s unique demands.

Device design and engineering must therefore advance in parallel with drug development, supported by rigorous modelling, interdisciplinary expertise, and integrated scientific frameworks. By uniting therapeutic design with delivery system innovation, the field is laying the groundwork for meaningful progress in neurodegenerative diseases and accelerating the pace of CNS therapeutic innovation.

References

    1. Yang HM. Overcoming the Blood-Brain Barrier: Advanced Strategies in Targeted Drug Delivery for Neurodegenerative Diseases. Pharmaceutics. 2025 Aug 11;17(8):1041. doi: 10.3390/pharmaceutics17081041. PMID: 40871062; PMCID: PMC12388969.

    1. Gao J, Gunasekar S, Xia ZJ, Shalin K, Jiang C, Chen H, Lee D, Lee S, Pisal ND, Luo JN, Griciuc A, Karp JM, Tanzi R, Joshi N. Gene therapy for CNS disorders: modalities, delivery and translational challenges. Nat Rev Neurosci. 2024 Aug;25(8):553-572. doi: 10.1038/s41583-024-00829-7. Epub 2024 Jun 19. PMID: 38898231.

    1. Wu, D., Chen, Q., Chen, X. et al. The blood–brain barrier: Structure, regulation and drug delivery. Sig Transduct Target Ther 8, 217 (2023). https://doi.org/10.1038/s41392-023-01481-w

    1. Hunt MA, Hunt SAC, Edinger K, Steinauer J, Yaksh TL. Refinement of intrathecal catheter design to enhance neuraxial distribution. J Neurosci Methods. 2024 Feb;402:110006. doi: 10.1016/j.jneumeth.2023.110006. Epub 2023 Nov 13. PMID: 37967672.

    1. Yuan T, Zhan W, Terzano M, Holzapfel GA, Dini D. A comprehensive review on modeling aspects of infusion-based drug delivery in the brain. Acta Biomaterialia. 2024 Sep 1;185:1-23.

    1. Lonser RR, Sarntinoranont M, Morrison PF, Oldfield EH. Convection-enhanced delivery to the central nervous system. J Neurosurg. 2015 Mar;122(3):697-706. doi: 10.3171/2014.10.JNS14229. Epub 2014 Nov 14. PMID: 25397365.

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Delivering complexity: device considerations for two-component injectable formulations

Featured in ONdrugDelivery, María FM Balson shares her expertise in device selection for two-component injectable formulations, and why this product area is becoming increasingly important.

Since the 1980s, when modern-day prefilled syringes (PFSs) and intravenous (IV) bags became prevalent, injectable drug delivery has steadily moved towards ready-to-use formats and integrated devices – as evidenced by the widespread adoption of self-injection devices such as autoinjectors and pen injectors.

Human factors considerations, now recognised as integral to safe and effective use of such drug-device combination products, have driven a clear trend towards simpler, more automated solutions with fewer use steps. This shift has enabled at-home care for more therapies than ever before – a key development given the growing strain on healthcare systems.

Nevertheless, the delivery of certain drugs, such as lyophilised injectables, often remains burdensome and dependent on administration by specially trained professionals. As injectable therapies evolve and become more complex, unique challenges and opportunities emerge.

Two-Component Injectables on the Rise

Let’s define two-component formulations as those consisting of two parts that, for stability or other reasons, must be kept separate throughout the product’s shelf-life, and are delivered together at the point of administration. The two constituent parts may be a solid drug and a liquid solvent or diluent (e.g. sterile water for injection) that must be mixed thoroughly before use. Alternatively, both constituents may be liquid, in which case they may either require mixing prior to delivery or be delivered sequentially (Figure 1).

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Figure 1: A simplified model of two-component injectables, classified according to the state of matter of constituent parts.

The Archetype: Solid/Liquid Reconstitution

Reconstitution is the process of adding a liquid solvent to a solid medication to dissolve it and form a solution. This may be required, at point of use, when a drug is unstable in liquid form and must therefore be stored dry. In such cases, the formulation is often filled as a liquid and then lyophilised (freeze dried) in situ. Alternatively, it may be manufactured and handled as a powder.

Freeze drying is an effective way to increase formulation stability. For small molecules, it can eliminate the need for cold-chain storage. For biologics (especially those that are large, complex or prone to aggregation) it can be a necessity in order to achieve an acceptable shelf-life.

“Lyophilised formulations now represent over 30% of all FDA-approved parenteral medications – and demand for lyophilised parenteral products is increasing.”

Lyophilised formulations now represent over 30% of all US FDA-approved parenteral medications1 – and demand for lyophilised parenteral products is increasing, as evidenced by past drug approvals (~35 such drugs were approved by the FDA each year over the past decade, compared to ~12 per year in the decade prior2). Considering lyophilised parenterals approved in 2023, oncology and infectious disease indications represented the largest share, together accounting for ~75% of total approvals.2

As lyophilisation is on the rise, so too are devices to simplify reconstitution. A wide range of solutions are available beyond the well-established vial-and-syringe method – from primary container adaptors to dual-chamber systems.

Solid/Liquid Suspensions

Suspensions are a dosage form in which insoluble solid particles are mixed into a liquid medium. They enable delivery of insoluble drugs and can be used to formulate long-acting injections. Suspensions may be supplied as separate wet and dry components (in which case the liquid phase is added to the solid phase and mixed prior to administration) or in a single primary container that is shaken to resuspend.

While solutions can readily be reconstituted with gentle swirling, suspensions usually need a greater energy input to achieve even mixing – the required amount varies greatly depending on the chemical and physical properties of the formulation. In some cases, vigorous shaking is insufficient and benchtop equipment, such as a vortex mixer, must be used.

Given sufficient energy input, the particles will be uniformly dispersed within the liquid, however the resulting mixture will be heterogenous and unstable; it will eventually settle. Therefore, suspensions must be thoroughly mixed immediately before use. Inconsistent dispersion can lead to inaccurate dosing or needle clogging – persistent challenges for device integration.

Injectable suspensions are becoming more prevalent, particularly for severe chronic conditions such as schizophrenia and HIV,3,4 where extended-release formulations are of particular value and which are often reliant on a suspension format to produce a long-acting depot. When formulated as separate wet and dry components, these products largely rely on vial-and-syringe or vial-adaptor workflows, with the occasional exception, such as Eligard’s reciprocating syringes, or the Abilify Maintena dual-chamber syringe.3,4

Liquid/Liquid Mixtures

Injection of two-liquid mixtures is rarer but not unheard of. Two liquids may be mixed and delivered together out of:

  1. Necessity: when a formulation consisting of two fluid phases is unstable in mixed form, but must be mixed prior to injection in order to achieve the intended therapeutic effect (e.g. API and polymer solutions that mix to form a long-acting depot).
  2. Convenience: if two liquid formulations are frequently administered together, such as in combination vaccines, pharma companies may choose a dual-chamber presentation over developing a coformulation, such as with Vivaxim.6 In this case, mixing isn’t necessary but rather a side effect of leveraging mature dual-chamber systems (which mix the two liquids prior to administration) rather than betting on more niche sequential delivery technology.

Sequential Delivery of Two Liquids

Sequential delivery of two different liquids through a single needle or injection port has been proposed for combination therapies, as well as for IV drug administration through a vascular access device (with the drug preceded, or followed, by a catheter flush).7

While there are several delivery technologies in development that might enable these use cases, only one combination product in this category is on the market at the time of writing, according to data from PharmaCircle. The DuoDote emergency-use autoinjector, based on a custom primary container, sequentially injects atropine and pralidoxime chloride. It is approved for treatment of nerve agent or insecticide poisoning.

Choosing the Right Device

Choosing the right device for a two-component injectable is often an exercise in trade-offs, highly dependent on the properties of the formulation itself, indications for use and the stage of development. Hereafter, this article will assume that a two-component injectable consists of separate wet and dry constituents that are reconstituted prior to injection, unless otherwise stated. This section will briefly cover the range of available technologies, and factors to consider when it comes to device selection.

“Choosing the right device for a two-component injectable is often an exercise in trade-offs, highly dependent on the properties of the formulation itself, indications for use and the stage of development.”

Vial and Syringe: Trusty but Burdensome

Two-component injectables are often supplied in vials, with off-the-shelf (OTS) needles and syringes used for fluid transfer and subsequent injection (Figure 2). By leveraging mature primary containers and fill-finish technologies, this approach benefits from low unit cost and a robust supply chain. It is also extremely versatile, with fewer restrictions on formulation volume and viscosity compared with alternatives, the ability to accommodate different doses in a single stock keeping unit, and no need for device-specific training.

On the other hand, the process is onerous and a high degree of technical expertise is required to perform all steps correctly. Dose accuracy is highly dependent on the user, and there is a greater risk of contamination and sharps injury compared with other methods, meaning that this type of system is typically limited to trained staff in clinical settings. Moreover, some drug wastage is inevitable, with vials often overfilled by 10–20% to ensure that a full dose can always be drawn.

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Figure 2: A summary of steps required for manual reconstitution using vials and syringes.

Devices to Simplify the Reconstitution Process

Given the growing prevalence of two-component injectables and the limitations of the established vial-and-syringe method, it is no surprise that a wide range of specialist devices have been developed to aid reconstitution. Figure 3 illustrates some of the solutions available.

  1. Primary Container Adaptors: Co-packaged with standard prefilled primary containers, these allow for drug components to be accurately pre-dosed during manufacturing, while maintaining low device and fill-finish costs.
  2. Integrated Manual and Automated Systems: Some of these leverage standard OTS containers, while others are designed around bespoke primary containers (e.g. dual-chamber cartridges).
    • Integration of device components reduces the number (and sometimes complexity) of use steps, reducing the burden of use and the likelihood of errors.
    • Automated devices take this further by incorporating mechanisms in the design (such as springs or electronics) to enable reconstitution and/or delivery with minimal user input.

 

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Figure 3: Examples of reconstitution devices for intravenous, intramuscular and subcutaneous administration. Devices marked with an asterisk are in development at the time of writing; the others are on the market. Note that prefilled dual-chamber systems can fall within the “integrated manual” or the “automated” categories, depending on device function.

Horses for Courses: Different Drugs Have Different Needs

When choosing a device, key trade-offs include cost, time to market, dose accuracy and ease of use. Consider:

  • Properties of the Formulation: All reconstitution devices have their strengths and limitations; the choice of device must be compatible with the needs of the formulation. For example, dual-chamber PFSs are limited to products with relatively low volumes that reconstitute readily.
  • Use Case and Dose Accuracy: The choice should be made with the final user in mind; integrated and automated systems greatly simplify usage, making accurate reconstitution accessible to users with less technical expertise (e.g. patients in the home setting).
  • Supply Chain Implications: The choice of primary container is the single most important factor influencing development timeline and manufacturing cost of the device. Dual-chamber fill-finish is highly complex; expertise is rare and CMO capacity limited.
  • Stage of Drug Development: Priorities differ depending on the stage of development. For example, a novel drug in clinical trials may benefit from the use of vials, since they offer flexible dosing and use only OTS components, whereas more integrated systems may be introduced post-launch to encourage wider adoption.

Dual-Chamber Delivery Systems

Prefilled dual-chamber systems (DCSs) are “all-in-one” devices built around bespoke primary containers, designed to simplify the reconstitution and delivery of two-component injectables. This final section delves deeper into this device category – strengths, limitations and key design considerations.

Anatomy of a Dual-Chamber System

In a DCS, the primary container consists of a barrel (typically made of glass) divided into two chambers by a central stopper. This barrier keeps the drug components separate from each other throughout storage. Once the DCS is activated, a bypass mechanism allows fluid to flow from the back (wet) chamber into the front (typically dry) chamber (Figure 4).

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Figure 4: Use steps and function of a typical DCS embodiment. Note that the linear application of force causes the bypass mechanism to activate, opening a fluid path that connects the two chambers.

DCSs vary in type of closure and bypass:

  • The closure can be PFS-style or cartridge-style (Figure 5).
  • The bypass is usually external (a blister bypass), but can also be internal (such as the multi-groove design of the Genotropin MiniQuick – Figure 5, Device 5). Note that an internal bypass allows the use of standard syringe or cartridge tubs, which is advantageous for manufacturing. Emerging designs, such as Credence MedSystems’ fenestrated needle bypass, also have the additional benefit of being compatible with OTS syringes.
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Figure 5: Approved DCS products (all marketed, bar Tanzeum, which has been discontinued). Left: dual-chamber prefilled syringes. Right: integrated injection devices built around dual-chamber cartridges. Device 1 contains a lyophilised suspension; Devices 2, 4, 5 and 6 contain lyophilised solutions; and Device 3 contains two liquids for co-administration.

Bespoke Primary Containers: A Double-Edged Sword

Like other specialist reconstitution devices, DCSs make administration of two-component injectables accessible to a wider range of users and care settings. They require less technical expertise to use accurately and consistently, with fewer and simpler handling steps, pre-measured drug components and reduced sharps exposure.

“Thanks to this design, DCSs can readily be integrated into devices with enhanced usability and/or advanced features.”

However, their unique strength lies in their form factor – the single barrel with a bypass that can be activated with a co-linear application of force (so both mixing and delivery are done by pushing on the rear plunger in a straight motion). Thanks to this design, DCSs can readily be integrated into devices with enhanced usability and/or advanced features. For example:

  • Xyntha Solofuse, an easy-to-use device with a simple finger flange (Figure 5 Device 2).
  • Caverject Impulse, an integrated manual system with dose selection capability (Figure 5 Device 4).
  • The reusable Skytrofa Autoinjector, pictured in Figure 3 with the green needle guard.

The flip side of the form-factor coin is that complexity is pushed into the manufacturing and filling process. Fill-finish for these devices requires specialist equipment and know-how (as noted above, expertise is rare and capacity is limited) and lyophilisation is inherently less efficient in the dual-chamber geometry compared with vials (smaller batches, poorer energy transfer, longer cycle times6). It all adds up to greater up-front investment and time-to-market, higher unit cost and a restricted supply chain.

For this reason, DCSs have so far been limited to premium value products, such as those used to treat rare diseases (e.g. haemophilia, growth hormone deficiency) or those that solve complex or critical clinical challenges (e.g. unmet needs, home care).6

Design Considerations

Current marketed DCSs have inherent technical limitations that impact formulation compatibility and device design. For example:

  • Capacity is limited to ~4 mL total reconstituted volume: Headspace in the front chamber must be sufficient to accommodate the initial plunger stroke required to open the bypass, both drug components, and additional room for swirling and mixing. Therefore, there is a limit to how much can be delivered with these devices before they become too large to be practical.
  • Venting and orientation are important: There usually needs to be a path to atmosphere during mixing to avoid pressure build-up in the front chamber (if there is a large amount of headspace in the powder chamber, this may not be required). In all cases, excess air must be vented prior to injection, which can be challenging and requires careful handling, as the device must be kept upright whenever there is a path to atmosphere to avoid drug spilling through the needle.
  • Plunger motion must be well controlled: When the bypass opens, the pressure in the system drops sharply. Unless the plunger’s forward motion is well controlled, there is a risk of prematurely locking out the fluid path, which would prevent the liquid in the back chamber from being fully incorporated into the mixture. To prevent this, many devices incorporate a screw mechanism that enforces a slower twist-to-mix action.
  • They are best suited to lyophilised formulations that are readily reconstituted with gentle swirling: Suspensions can only be delivered if the energy required to suspend is low. In addition, sequential delivery is not possible without specialised valve design (some mixing will always take place with the currently marketed DCSs). Finally, very particular considerations apply to the delivery of liquid/liquid mixtures – space is at an even greater premium, venting becomes critical and mixing performance varies widely depending on the specific device and formulation.

Looking Ahead

Meeting the next generation of injectable delivery challenges will demand the best of device innovation, alongside advances in formulation and process development. As therapies grow more complex, the need for close cross-functional collaboration becomes increasingly critical.

Developers of combination products will continue to face trade-offs between usability, flexibility, cost and manufacturability. To navigate these successfully, device and formulation experts must work hand-in-hand with clinical, regulatory, commercial and access stakeholders. Working together, we can deliver medicines that are fit for purpose today, and ready to meet the needs of tomorrow.

References
  1. Kumar S et al, “Application of lyophilization in pharmaceutical injectable formulations: An industry and regulatory perspective”. J. Drug Deliv. Sci. Technol., 2024, Vol 100, article 106089.
  2. Gray J, “LyoHUB 2024 Annual Report”. 2024. Available from: https://pharmahub.org/resources/1112
  3. “Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations”. Web Page, US FDA, accessed Jul 2025.
  4. “Purple Book: Database of Licensed Biological Products”. Web Page, US FDA, accessed Jul 2025.
  5. “DailyMed: Prescription drug labeling and information.” US National Library of Medicine, accessed Jul 2025.
  6. Werk T et al, “Technology, Applications, and Process Challenges of Dual Chamber Systems”. J Pharm Sci, 2016, Vol 105, pp 4–9.
  7. Sousa et al, “Brief Report on Double-Chamber Syringes Patents and Implications for Infusion Therapy Safety and Efficiency”. Int J Environ Res. Public Health, 2020, Vol 17(21), art 8209.

Get in touch

This article highlights how the right device can turn complex two-component injectables into simple, safe, and accessible treatments. If you’re exploring delivery challenges or want to design patient-friendly solutions for advanced formulations, we’d love to talk.

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By Cambridge Design Partnership

Designed to deliver: How collaboration created an award-winning device that puts patients first

When Credence MedSystems set out to build on the capabilities of their Dual Chamber Syringe System (DCSS), they weren’t just looking to adapt it – they wanted to expand its potential. Together, we set out to create a new platform for at-home, sequential-drug delivery: one that combined human-centered design, deep technical know-how, and the power of partnership. Over the course of the project, our teams worked together to bring that vision to life. The result? A Red Dot 2025 award-winning demonstration autoinjector that not only showcases the functionality of the DCSS, but also reimagines how two drugs can be delivered at home in one simple injection.

Three Ingredients for Award-Winning Device Design

1. End-to-End Expertise

This project brought together two areas of specialist knowledge. Credence brought the core technology: a dual-chamber syringe system with automatic needle retraction that uses standard glass components, designed for sequential delivery of two formulations. Our team contributed deep experience in autoinjector design, usability, and manufacturing engineering. We translated complex drug delivery requirements into devices that are safe, manufacturable, and easy to use.

2. Close Collaboration

This was a shared, iterative development process built on close collaboration. From the outset, the teams worked together to define key requirements and align on a shared vision. By combining Credence’s knowledge of their container system with our insight into autoinjector mechanisms and user experience, This allowed us to accelerate from concept to working demonstration.

We shaped the engineering and design direction through regular feedback loops. Both teams were actively involved in decision-making throughout. When the Credence team visited our site in Cambridge, UK, we held a hands-on working session to evaluate both functional prototypes and industrial design handling models. Together, we assessed the feel of device activation, form factor, and visual cues. We blended technical and aesthetic considerations to arrive at the perfect overall experience.

The feedback was immediate. One mechanism was described as “smooth as butter”. This was a clear signal that we were on the right path.

3. Built-in User-Centered Thinking

While the request was to develop a reloadable, robust model for demonstration purposes. The long-term goal was always to support at-home use. We designed the experience to closely emulate the familiar, two-step workflow of a single-chamber autoinjector, while delivering the additional benefit of dual-drug administration. In addition, we made the demo unit reusable and resettable for hands-on use. We developed it with a clear development pathway towards a single-use, commercial device.

We also considered communication and clarity from the outset. Exploring iconography, leaving space for regulatory labeling, and ensuring the device visually conveyed key aspects of the user benefits.

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From initial sketches…
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…through concept renders…
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…to the real thing

Platform Flexibility

What makes this device stand out isn’t just the sequential delivery of two formulations. It’s the fact that the same primary container can be used across both prefilled syringe and autoinjector formats without changing any drug-contacting components. This flexibility helps reduce development burden. It simplifies supply chains and makes it easier for pharmaceutical partners to scale and adapt their delivery format over time. There’s also a clear benefit for patients. Fewer injections, simpler instructions, and added confidence that both parts of the treatment are delivered, every time. Beneath it all lies a sustainability advantage. With a sequential delivery device, there’s only one autoinjector to manufacture, ship and dispose of. This can make a meaningful difference at scale.

As a result, this wasn’t just a concept exercise. It was a real-time demonstration of what’s possible when two expert teams bring their strengths to the table. We developed a fully-functioning demo platform and in doing so, also laid the groundwork for future commercial evolution, including a clear view of what it would take to move from demo model to single-use device.

Our shared focus, technical excellence, and momentum powered this collaboration. We’re proud to see this work recognized with an industry award.

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Connect with CDP

For more on how to turn patient-centred thinking and collaborative engineering into award-winning drug delivery devices, contact Cambridge Design Partnership.