Fill / Finish Services
Novocol Pharma delivers aseptic filling for cartridge, prefilled syringe, and vial formats using a blend of mature manufacturing heritage and modern isolator-based technology. Our teams support clinical to commercial scale programs, bringing deep experience in device-integrated products, RTS and RTU component handling, and both aseptic and terminal sterilized workflows. With highly trained operators and a flawless media fill record, we help our clients achieve consistent, compliant, and scalable production.
Cartridge Expertise Backed by Decades of High-Volume Manufacturing
Cartridges are where Novocol Pharma has unmatched depth. With decades of experience producing over one million sterile cartridges per day at the Cambridge campus, cartridge fill finish is supported by well-established equipment, RTS processing setups, and operators who understand the nuances of siliconization, mechanical performance, and sealing.
This expertise extends into combination-product programs, where pen and autoinjector requirements provide another layer of complexity. Our customers gain access to a mature cartridge ecosystem paired with the agility of a dedicated CDMO.
Flexible Filling Capabilities for Cartridges, Prefilled Syringes, and Vials
Novocol Pharma’s filling network includes multiple cartridge lines and a modern isolator-based flex line that supports RTU syringes, RTU vials, and select cartridge formats. This flexibility allows programs to move from early-phase needs to later-stage scaling without changing partners.
Our fill finish capabilities include:
Support for RTS (washed, depyrogenated) and RTU (pre-sterilized) components
Isolator-based filling with automated H2O2 decontamination
No-touch transfer loading for RTU syringes and vials
Filling options for liquid and certain terminally sterilized products
Compatibility with client-owned or bespoke equipment when needed
Fill volumes and batch scales that support development through commercial readiness
This range ensures our customers can pursue the right container and process path based on stability, usability, and regulatory expectations.
Aseptic Processing Built on Skilled Operators and Proven Performance
Equipment matters, but operator skill determines aseptic success. Novocol Pharma’s teams bring years of sterile technique experience supported by comprehensive training, cleanroom discipline, and repeatable workflows.
No media fill positives recorded across more than twenty media fills and over 500,000 units filled since 2016.
For our clients, this means aseptic confidence built on real performance, not theoretical capability.
RTU and RTS Processing Tailored to Program Needs
A defining feature of Novocol Pharma’s fill finish model is the ability to support both readiness pathways:
Ready to Sterilize (RTS)
Ideal for cartridge programs that benefit from internal washing, depyrogenation, and siliconization control. Novocol Pharma manages RTS components using established in-house processing and tunnel-based systems.
Ready to Use (RTU)
Supported on the modern flex line, RTU components arrive gamma-irradiated or EO-sterilized and are introduced through no-touch transfer into the isolator. RTU compatibility covers:
- Prefilled syringes
- Vials
- Select cartridges
This dual-path model gives our customers flexibility to choose the right component strategy for their molecule, device, and stability considerations.
Integrated Quality, Inspection, and Support Systems
Inspection and quality control are built into every fill/finish program. Novocol Pharma uses a mix of manual, semi-automatic, and automated visual inspection to ensure container integrity across formats.
Capabilities include:
- Manual inspection for early-stage or complex formats
- Semi-automatic inspection for cartridges and PFS
- Automated inspection for high-volume programs
- Qualification expertise for inspection equipment, including customer-owned systems
Cold chain management, high-potency handling, and appropriate containment controls are incorporated as needed to support diverse program requirements.
Fill Finish Services
