Our facility was purpose-built to meet increasing market demand for small-scale, shorter sterile drug product development timelines, while consistently maintaining regulatory compliance.
Today, we reliably support our customers with the aseptic filling and lyophilisation of conventional, biologic and cytotoxic drugs into vials. Helping clients across the globe meet their project milestones, we provide rapid access to manufacturing slots and quick release of drug product to ensure tight timelines are successfully met.
Aseptic filling of sterile drugs, also known as sterile filling/finish, remains one of the most critical processes in biopharmaceutical manufacturing. This is due to it’s highly technique driven processes and the potential safety impact to the end user, usually an already compromised patient. There are only indirect safeguards for the sterility of the filled drug after it is stoppered and capped in the cleanroom.
What are our sterile fill finish capabilities?
- Filling into 2ml-100ml glass vials
- Bulk volume of up to 70 litres
- Bulk lyophilisation in Lyoguard trays
- Batch sizes range from 100-3000 vials
- Controlled-temperature filling
- In-house vial washing
- GMP manufacture of small molecules
- GMP manufacture of biologics such as antibodies, proteins, peptides, DNA, ADCs
- GMP manufacture of cytotoxics/cytostatics/high potent APIs in dedicated cleanroom facility
- Drug product manufactured under GMP to meet regulations for clinical trials in US and Europe
We are a specialist in the field of sterile filling of pharmaceuticals into vials. If you require a manufacturing partner to aseptically fill a liquid or lyophilised drug product into vials, then rest assured that your drug development project will be in safe hands at Symbiosis.
Over the last decade, the development and refinement of gene therapy has led to high demand for the manufacture of this niche drug product that often requires flexibility and ingenuity to successfully execute batch manufacturing. With the founding principle of Symbiosis being to specialise in low volume manufacture we are set up to provide a robust and reliable solution to this increasing demand.
Operating within dedicated cleanroom facilities at our GMP MHRA-licensed facility in Scotland, our experienced team routinely fill biological pharmaceutical products such as antibodies, proteins, peptides, DNAs, RNAs, ADCs and cytotoxic, cytostatic and highly potent APIs.
We deliver a lyophilisation service by either aseptic or low bioburden cleanroom dispensing of up to 100 litres of bulk product per batch. Whether you require a one-off batch or the ongoing bulk lyophilisation of API or finished product, our technical experts can support your supply needs.