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.
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 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.
We have extensive experience in taking precious, complex drug products from manufacture to QP release.
Clinical and small scale commercial manufacturing of advanced therapeutics such as viral vectors for cell and gene therapies, oncolytic viruses and critical raw materials such as plasmids.
Extensive experience in delivering hundreds of projects allowing us to support your clinical trials.
Symbiosis can support with challenging manufacturing and handling requirements that need specialist knowledge and experience.
Overcome your development and manufacturing challenges with a partner that has the experience and capabilities to handle your highly potent ADC
Symbiosis has provided GMP manufacturing across a wide range of small molecule applications, including highly potent materials requiring specialist handling.