“Every milliliter lost translates to delayed timelines and increased costs.”
For early-phase biotech companies working with limited API batches, this is the central challenge of sterile injectable manufacturing. Peter Mollison, CEO and co-founder of Eramol, a UK-based pharmaceutical CMO, has built an entire facility around solving it.
Peter Mollison and David Cox, Site Director at Eramol, joined the PharmaSource podcast to discuss the company’s new purpose-built sterile injectable facility opening in Q2 2026 in Sittingbourne, Kent. The 11,000-square-foot site features a 2,000-square-foot GMP Grade A/C/D clean room suite engineered to achieve less than 1% material losses, well below the industry standard of approximately 10%.
In this episode, Peter and David explain the engineering decisions behind the low-waste design, how the facility’s end-to-end capabilities simplify outsourcing for biotech, academia, and research clients, and what it takes to build a sterile manufacturing site that meets 2023 EU GMP Annex One standards.
Designing for Minimum Waste From the Ground Up
Eramol began as a virtual operation roughly a decade ago, initially outsourcing key services before progressively bringing them in-house. Warehousing, packaging, non-sterile manufacturing, and testing were all integrated over time. Sterile manufacturing was always the next ambition, and when the opportunity arose approximately two years ago, the team approached the facility design with a clear mandate: minimize material loss from day one.
“When we’re dealing with biotech companies, we know how valuable their drug substances are — and how potentially limited supply can be, specifically at the early phase. Minimizing waste was factored into our design specifications.”
David led the engineering execution of that intent. His approach was systematic: examining each processing step individually, identifying potential points of loss, and addressing them through deliberate design choices.
“We looked at keeping pathways as short as possible and how to clear those pathways — combined with managing cross-contamination risks and ensuring system integrity. By considering each element independently and as a system, we were able to identify where potential losses occur and reduce them.”
The Business Impact of Waste Reduction for Biotech Clients
For small biotech companies, material loss is more than an efficiency metric. It determines whether a clinical program can proceed on schedule. When API supply is constrained, even modest losses can force additional manufacturing campaigns, adding cost, time, and analytical complexity.
“If you have losses within the system, whether through sampling or line losses, that limits the amount of material you can generate. If you’re making less at the end of a campaign, you may need to run multiple batches. That adds cost and manufacturing time to deliver the same output. And if you’re running stability programs, you need a sufficient quantity from a single batch to demonstrate stability effectively. Multiple batches introduce variability into the dataset, which can cause delays.”
The facility’s design addresses this at the engineering level by keeping fluid path lengths minimal, optimizing hose diameters, selecting filters that avoid fluid hold-up, and using pump or gas transfer systems to clear lines and maximize yield after each processing step.
End-to-End Integration
Beyond fill-finish, Eramol’s Kent facility offers packaging, labeling, QC testing, UK and EU QP release, storage, and global distribution, all from a single location. For biotech clients, this breadth of capability translates into a meaningfully different outsourcing experience.
“Our extensive experience as a QP release site for the last decade ensures that all our upstream services — formulation work, QC testing, manufacturing, packaging, labeling, blinding — are aligned toward one end: getting the product to the patient. There’s no point having the best formulation development service if you can’t get the product into the market.”
Peter describes the practical benefit for clients. A single contracting relationship, one point of contact for project management, and a dedicated QP assigned to each project from day one. This model reduces reliance on third-party vendors, accelerates decision-making, and gives clients visibility across the entire lifecycle of their program.
“Because 99% of what we do is in-house, the client and we are in control of everything. There’s no waiting for another supplier to release the product to market. We do that in-house. We don’t wait for another supplier to distribute into Europe. We do that in-house.”
Batch Sizes, Flexibility, and a Scalable Roadmap
The facility is designed to serve the small-to-medium batch requirements that characterize early-phase clinical development. Eramol works on solution make-up volumes of approximately 5 to 10 liters, with two distinct manufacturing pathways: an aseptic isolator route for sterile fill-finish, and a terminal sterilization route. Both pathways support multiple products and provide flexibility across dosage forms, including vials, cartridges, and syringes.
For clients asking about minimum or maximum batch sizes, David’s answer is that the minimum is determined by sampling requirements, and the maximum by the available input volume.
Looking ahead, Peter outlined an expansion roadmap built into the original facility design. A dedicated fallow space has been reserved for future growth, with plans underway to introduce a fully automated filling line capable of handling batches up to 50 liters, targeted for 2027–2028. Cartridges and syringes are expected to be available from late 2025 onward, enabled by the flexible processing equipment already installed.
“We left a significant fallow area in the facility specifically to grow into. We’re currently considering a fully automated filling line for batches up to 50 liters. The roadmap points to 2027–28 for that expansion build.”
Global Distribution and the Compliance-First Philosophy
Eramol’s distribution capability extends well beyond the UK. The company ships to the US through local depots, across South America, the Asia Pacific region, and Australia. Post-Brexit, a Dublin facility was acquired to maintain EU QP release capabilities in-house — a critical operational decision for clients running EU-territory trials.
For clients managing multi-country clinical programs, including those involving controlled substances, Eramol’s logistics team maps out optimal distribution strategies as part of the initial project feasibility stage, identifying the most efficient route from supply chain to market.
Peter frames compliance as a foundational value, not a checkbox. Eramol was founded by QPs, and that heritage shapes how the company approaches regulatory change.
“Compliance is a key part of our ethos. We’re founded by QPs, so the quality system, horizon scanning, anticipating changes from both a regulatory and technical perspective — these are built into how we operate throughout the lifecycle of every project we handle.”
Lessons From Building a State-of-the-Art Sterile Facility
Both Peter and David shared candid reflections on the build process. For Peter, the most notable challenge was equipment lead times. Eramol chose a semi-bespoke isolator over an off-the-shelf alternative — a decision that extended the lead time to 12–15 months, compared with 4–6 months for a standard unit, but one that Peter considers essential for achieving the facility’s performance objectives.
For David, the most instructive aspect of the build was observing how the broader industry is navigating the 2023 EU GMP Annex One revisions. Many suppliers and equipment manufacturers are still catching up.
“The surprise for me was the desire to collaborate between different companies. We all bring something different to the table. Where we worked on more bespoke or developmental equipment, each partner added a different input, and the output was something really successful. Had it been a standard off-the-shelf approach, we wouldn’t have achieved the same result.”
That collaborative approach, David suggests, is also how the facility was qualified. Rather than locking down processes to a single operational mode, Eramol used a bracketing strategy during commissioning and qualification, giving clients a degree of flexibility within regulatory boundaries.
Addressing the Sterile Fill-Finish Capacity Gap
Demand for sterile injectable manufacturing capacity is a recognized constraint globally, driven by the growth of biologics, long-acting injectables, and personalized therapies. Peter sees that demand reflected directly in Eramol’s client inquiries, which span clinical to commercial, small to large scale, and originate from across the globe.
For a company founded by QPs with a decade of experience managing complex supply chains, the timing of the new facility is deliberate. Eramol is positioning itself to serve the segment of the market that needs a technically sophisticated, agile, compliance-driven partner. One that can manage early-phase sterile manufacturing without the scale constraints that make larger CDMOs less accessible.
“Being at the forefront of this — able to offer new services to the market — is definitely a bonus for us.”
