Flexible Fill/Finish Solutions to Bridge the Clinical-to-Commercial Gap

Over the past five years, the pharmaceutical landscape has undergone a dramatic transformation, particularly in the fill/finish manufacturing sector. The industry has weathered two major capacity crunches in rapid succession. The first, sparked by the global demand for COVID-19 vaccines and therapeutics, consumed nearly all available sterile filling capacity worldwide. Just as that demand began to subside, the market experienced another surge, this time driven by GLP-1 receptor agonists for weight loss and diabetes management. That wave culminated in the high-profile acquisition of Catalent’s fill/finish assets by Novo Nordisk, underscoring how acute demand pressures can reshape the outsourcing ecosystem. Today, GLP-1 products continue to dominate high-volume capacity needs, but they represent just one piece of a rapidly diversifying market.

Simultaneously, the rise of personalized medicines, orphan drugs, and complex biologics has shifted the industry’s center of gravity toward smaller, less predictable batch sizes. Many of these therapies target narrowly defined patient populations, use highly potent or temperature-sensitive formulations, and rely on formats that support infrequent dosing. Some have already gained regulatory approval, and many more are moving swiftly through the pipeline. The long-term commercial demand remains uncertain in most cases. Drug developers must therefore navigate accelerated development timelines and the challenge of making manufacturing decisions without clear forecasts.

Compounding the complexity is the growing use of expedited regulatory pathways, such as Breakthrough Therapy and Fast Track designations, which compress development cycles and intensify the pressure to establish robust chemistry, manufacturing, and controls (CMC) data early. For many programs in phase II and later, the bottleneck has moved from generating clinical data to how quickly and reliably teams can transfer, validate, and scale manufacturing for commercial launch. In this environment, drug developers expect contract development and manufacturing organizations (CDMOs) to enable not just rapid entry into first-in-human trials but also seamless progression from clinical to commercial supply, without compromising quality or compliance.

Meanwhile, sterile fill/finish operations face rising regulatory scrutiny. Recent updates to Annex 1 and other global guidelines have elevated expectations around contamination control and process validation. However, interpretations of what constitutes “best practice” vary widely across companies and regulatory agencies, especially between clinical and commercial phases. This regulatory ambiguity further underscores the need for flexibility in technology platforms and operational strategies as drug developers seek partners to support their products across an evolving regulatory and technical landscape.

As the pharmaceutical market continues to fragment — with demand fluctuating between high-volume blockbusters and small-batch, niche therapies — drug developers need fill/finish partners that truly understand their current and future needs and can evolve alongside their products. Drug developers need outsourcing providers that offer not just capacity but adaptive capacity: technical and operational flexibility that can accommodate shifting volumes, complex formats, and accelerated timelines across the clinical-to-commercial continuum.

To serve this new reality, CDMOs must excel in two distinct but interconnected forms of flexibility. The first is capacity flexibility, which refers to the ability to scale production up or down as demand evolves, whether due to changes in patient population, timing of regulatory approvals, or commercial uptake. The second is technical flexibility, which refers to the capability to handle a wide range of drug product presentations and formulation challenges. The needed flexibility includes sterile filling of vials, syringes, and cartridges in both small and large batches and expertise in handling diverse modalities, from highly potent compounds to lipid nanoparticles, and other complex formulations.

Equally important is the ability to support products as they transition through development phases. For example, a therapy may begin in a vial for early clinical trials but ultimately reach the market in a syringe or cartridge device. CDMOs must build the capability to manage these presentation shifts seamlessly, without compromising timelines or requiring redundant process development efforts. Supporting this flexibility may also involve stocking change parts, validating bracketed container closure systems, and working with multiple vendors to ensure uninterrupted supply.

True responsiveness requires a deliberate service strategy that strikes a balance between breadth and focus. The most effective CDMOs structure their offerings to meet a broad spectrum of client needs without introducing unnecessary operational complexity or supply chain strain. A CDMO can achieve these goals by curating a portfolio of filling technologies and capabilities that can flex as demand changes while maintaining a clear path for scale-up.

Forward-looking strategies also take the future into account. By designing facilities with modular layouts, unclaimed cleanroom space, and multi-format-ready infrastructure, CDMOs can rapidly expand in response to customer growth. This built-in headroom, guided in part by close collaboration with clients, positions them to support the needs of today’s drug candidates and the market leaders of tomorrow.

For over 20 years, Afton Scientific has established a reputation as a reliable and high-performing partner in sterile fill/finish. As a small, focused CDMO, Afton has prioritized technical excellence, regulatory rigor, and a customer-first approach. These values have earned the company a loyal client base and a strong record of repeat business.

Its ability to pair high-quality manufacturing with unusual agility has long set Afton apart. The company has consistently delivered flexible solutions across a variety of project types, dosage forms, and timelines while maintaining an exceptional track record with global regulatory authorities. That operational strength has made Afton a trusted partner for customers with diverse needs, from early-stage innovators to commercial-stage developers seeking a nimble alternative to large-scale providers.

Now, with market conditions calling for more adaptable and accessible fill/finish capacity, Afton is uniquely positioned to support customers on their product development journey. The company is making targeted strategic investments to significantly expand its capabilities and capacity without losing the responsiveness and collaborative spirit that have defined its model. This expansion is not a pivot but a scaling of what already works, designed to meet the growing demand from existing clients and new partners seeking a manufacturer that can combine technical breadth with a human touch.

At Afton Scientific, flexibility isn’t a buzzword; we build it into every layer of our operations. From container types to formulation processes, from batch sizes to analytical support, our infrastructure and expertise accommodate change. This flexibility enables us to support products throughout the entire development life cycle and respond quickly when project needs change.

Our filling lines accommodate a broad array of container formats, including vials, prefilled syringes, and cartridges, with the ability to manage transitions between them as a program advances through clinical phases and into commercial production. This flexibility is especially important for therapies that start in vials but ultimately transition to delivery via a device or alternate presentation. Afton can guide that transition, maintaining a unified process and minimizing the need for repeated validations.

Our manufacturing environment supports a wide range of drug products, including those with complex active pharmaceutical ingredients (APIs) and specialized formulation requirements. We routinely handle temperature- and light-sensitive materials, high-concentration or high-viscosity drugs, and DEA Schedule II controlled substances, each with its own technical and regulatory considerations. This flexibility enables us to support products throughout the entire development life cycle and respond quickly when project needs change.

To further enhance our adaptability, we’ve partnered with a network of qualified component vendors and proactively secured change parts for multiple vial, syringe, and cartridge sizes. This foresight allows us to rapidly onboard new presentations without the long lead times or logistical headaches that often follow container changes. It also ensures that we can offer clients options tailored to their delivery strategy, not just what happens to be pre-validated.

Our multiple filling lines span different technologies and production scales, enabling us to run small development batches or pivot quickly to accommodate larger-volume needs. In-house analytical and microbiology laboratories, staffed by senior scientists with decades of experience, strengthen that responsiveness. By developing and validating methods internally, we minimize dependence on external labs and reduce the risk of delays at critical handoffs.

Finally, our long-term expansion strategy is rooted in scalable flexibility. As we grow our facilities and equipment base, we are deliberately investing in technologies and layouts that will enable us to serve a broader range of products, customers, and market demands without sacrificing the agility that defines our approach.

Afton Scientific’s expansion strategy is purpose-built to support the increasingly dynamic needs of the biopharmaceutical industry. Rather than simply adding capacity, Afton is investing in scalable, flexible infrastructure that empowers customers to grow, adapt, and accelerate their programs across development phases and product formats.

The expansion plan is two-fold: a near-term buildout with a state-of-the-art Flexfill production line to meet immediate demand and groundbreaking on a new facility designed for staged expansion. We engineered both assets with flexibility in mind, from cleanroom configurations to equipment specifications. Crucially, we designed the new facility with unclaimed modular space, which allows us to install additional filling lines quickly as needs arise. In line with evolving global inspection trends and the stricter sterility requirements of Annex I, we are installing top-of-the-line isolator filling lines and Annex I–compliant facilities to ensure we stay ahead of rising quality expectations. While we deliver the flexibility our clients need, we match it with the highest standards for sterility, contamination control, and facility design. This proactive “open capacity” model helps de-risk tech transfer timelines and ensures that scale-up doesn’t become a bottleneck as products mature.

In keeping with Afton’s customer-centric approach, existing clients will have input into designing and selecting new filling lines and technologies. This collaborative approach ensures that Afton aligns future capacity investments with real-world needs rather than speculative demand. Standardizing equipment across facilities also streamlines scale-up, tech transfer, and staff training, allowing Afton to preserve quality and efficiency even as it grows.

Recent investments reflect this forward-thinking strategy. The company is undergoing a threefold expansion of its in-house analytical laboratory, positioning it to support a broader array of assays, from early development through commercial validation. We are adding a new filling line utilizing ready-to-use (RTU) components to accommodate challenging configurations and accelerate project onboarding. Meanwhile, additional bulk lines are in development to support multiple presentation types — vials, syringes, and cartridges — on a single, flexible platform. Once validated, these lines will allow customers to pivot between formats as needed without redundant development cycles or lengthy requalification.

We are designing all of the new infrastructure to handle a diverse and simultaneous mix of products, with sufficient built-in capacity to support rapid onboarding and variable scheduling. The result is a future-proofed operation that balances growth with agility, an essential quality in a market where demand is as unpredictable as the science driving it.

At Afton Scientific, flexibility is more than a manufacturing principle; it’s a cultural one. From day one, the company has built its reputation on technical capabilities and the strength of its relationships. A high-touch, customer-first approach is central to Afton’s operations, and this ethos starts at the top and extends across every team and function.

 Maintaining that level of responsiveness and care is a top priority as Afton grows. While the company is investing in new facilities, technologies, and capacity, it is doing so with the clear understanding that scale must never come at the expense of service. The expansion strategy is deliberately paced, with milestones tied to real market demand and customer needs. That ensures not only operational sustainability but also cultural continuity.

 Afton’s long-tenured, experienced staff is key to preserving this high-touch model, and our customers don’t just benefit from this experience behind the scenes. They work directly with our senior leadership team, gaining fast access to decision-makers who bring a “can-do” mindset and a proactive, problem-solving approach to every project. This close collaboration ensures clear communication, realistic timelines, and solutions tailored to each client’s unique needs.

 Low turnover and a collaborative internal culture empower employees to take ownership of their projects, respond quickly to challenges, and build lasting relationships with clients. This continuity also enables the company to set realistic expectations, avoiding the industry pitfall of overpromising to win business, which often leads to missed deadlines and strained partnerships.

 As scheduling pressures and portfolio complexity grow, Afton is investing in both people and systems to ensure that delivery timelines remain reliable, onboarding is seamless, and communication remains clear. Flexibility is valuable, but credibility is essential, and Afton is committed to earning both every step of the way.

The biopharmaceutical industry is defined by constant evolution, and with that evolution comes a steady progression of new challenges. However, for agile, future-focused partners, those challenges are also the clearest opportunities for growth.

 Increasingly complex modalities, from cell and gene therapies to RNA-based products, antibody–drug conjugates (ADCs), and high-potency small molecules, are becoming commonplace in today’s pipelines. These therapies often require non-standard presentations, unique formulation conditions, and smaller, more variable batch sizes. Simultaneously, the rise of personalized medicine and orphan drug development continues to drive fluctuation in production volumes and delivery formats, making predictability the exception rather than the rule.

 In addition to these scientific shifts, drug developers must navigate a regulatory landscape that is becoming increasingly demanding and fragmented. Guidelines, such as EU Annex 1 and other regional frameworks, have raised the bar for sterile fill/finish operations; however, their implementation and interpretation vary across jurisdictions and product phases. Meanwhile, geopolitical uncertainties and supply chain vulnerabilities, exacerbated by recent global events, are prompting many companies to rethink how and where they manufacture critical therapies.

 In this environment, success depends on working with outsourcing partners who can anticipate change, respond quickly, and grow alongside their customers. Afton Scientific believes that flexibility — delivered through innovative design, customer-centric processes, and experienced teams — is the key to converting complexity into opportunity.