Aerial view across the Symbiosis Pharmaceutical Services site.

Commercial scale

Our aseptic commercial biologics manufacturing services are ideally suited for companies involved in niche markets and orphan indications that require relatively low volume sterile fill finish to reflect patient demands.

The challenge

If you are a developer looking to meet the needs of a small patient population, finding partners who are able to produce commercial product at the right scale can be difficult. This can be particularly true for the commercial production of ATMPs such as viral therapies which typically target smaller patient populations, as these require specialist handling.

Vials being aligned in tray for pharmaceutical product development

Specialist sterile product filling

Since 2014 Symbiosis has held a commercial manufacturer/importer’s license by the MHRA for the GMP-manufacture of aseptically-filled licensed commercial products.

The license enables us to offer exactly the same sterile product filling offering as we do for clinical trials, but for licensed products. We can therefore cater for the small scale commercial manufacturing of licensed biologic and small molecule products into vials. Our capabilities and expertise are particularly suitable for aseptic manufacture of viral vectors for in vivo or ex vivo applications. Symbiosis can also help with the manufacture of critical components used within the production process such as plasmids.

Our commercial capabilities

Our commercial capabilities

We can fill bulk liquid volumes under 100 litres, including products that require aseptic liquid filling and lyophilisation. These include:

  • Advanced therapies such as viral vectors
  • Critical components used within the production process such as plasmids
  • Biologics including mAb’s, proteins, peptides and RNA
  • Cytotoxic, cytostatic and high potent APIs including ADCs
  • Small molecules

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