Quality and Regulatory

Quality and Regulatory

Complete adherence to regulatory compliance and GMP biologics manufacturing standards is fundamental to everything we do at Symbiosis. There is no room for error when it comes to manufacturing injectable drug products.

Challenge

Challenge

The sterile manufacture of drug products is no easy task, especially when manufacturing for small patient populations. From small molecule to monoclonal antibodies (mAbs), ATMP viral vectors to vaccines; each therapy has its challenges.

We have a proven track record of managing the challenges of complex process control and validation requirements across most therapy types with specialist expertise.

Our certificates and authorisations

Our certificates and authorisations

Our facility holds a MIA (IMP) Licence issued by the MHRA. Symbiosis is licensed to aseptically manufacture small volume liquids, suspensions and lyophilisates for use in clinical trials.

Symbiosis also holds a MIA License for Marketed Product, issued by the MHRA. Symbiosis is licensed to aseptically manufacture small volume liquids, biological medicinal products, suspensions and lyophilisates for commercial use.

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Fill-finish expertise in handling the most complex of products

We have extensive experience in taking precious, complex drug products from manufacture to QP release.