Sterile Fill / Finish.
Your trusted partner in sterile processing
With extensive experience in sterile fill finish development and manufacturing, our team can support you with aseptic and terminally sterilized small volume liquids for parenteral, ocular and pulmonary delivery.
Fill/finish facility for biologics and small molecules
Purpose-built sterile facility
A new purpose-built 7,000sqft facility, designed specifically in line with the revised EU GMP Annex-1 regulations is due to be operational in Q1 2025.
The state-of-the-art build provides a new service to develop, manufacture, test and fill/finish sterile drug products for biologics and small molecules.
Alongside existing full-service formulation development and quality control labs our team can support your drug development with expertise and speed.
Vials and prefilled syringe fill-finish capability
sqft GMP sterile facility
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unit batch sizes
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processing rooms
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Aseptically prepared and terminally sterilised
Sterile fill/finish services for parenteral drug products
Our contract manufacturing capabilities and successful regulatory history supports you in maximising the success of your drug product.
Our sterile processing capabilities include:
– Sterile drug products – aseptically prepared and terminally sterilised.
– Liquid formulations for parenteral, ocular and pulmonary delivery.
– Wide range of molecules from small molecules to Biologics (including proteins, peptides and mAbs).
– Aseptically prepared lyophilized and spray dried powders.
Integrated CDMO services
Sterile fill / finish expertise you can trust
Our Leadership Team excels in steering products from pre-clinical to market. This extensive expertise forms the cornerstone of our service to you, ensuring hands-on involvement at every stage and every level of our business.
Alongside our upcoming aseptic capabilities, our formulation development across a broad range of dosage forms, clinical trial supply, and niche-scale commercial manufacturing for non-sterile dosage forms provides accessible scale-up and unparalleled project delivery.
Parerental Product testing
Our team supports you in every aspect of analytical and microbial testing including the QP release of your final product.
We work to ensure the early identification of lead prototype formulations suitable for clinical testing followed by the development of your product through the product cycle.
Through ASAPprime® our teams generate robust, accelerated stability data, from API drug substance stability to formulation development prototypes and final dosage forms.
Frequently Asked Questions
What is sterile fill/finish?
Sterile fill-finish is the final step in the drug manufacturing process for injectable medications and other parenteral products. It involves filling the drug product into its final containers (such as vials, syringes, or cartridges) under strictly controlled aseptic conditions to ensure sterility.
What are your sterile fill/finish capabilities?
- Formulation development and stability testing
- Aseptic preparation and terminally sterilized products
- Batch sizes up to 2,000 units
- Filling of vials and pre-filled syringes
- CMC sterility assurance package
