GMP Manufacturing
Biomay has been active and successful as a GMP-CDMO since 15 years. From cell banking to aseptic filling of drug product – we offer all GMP services from one hand.
cGMP: Current Good Manufacturing Passion
This is our passion: exerting our technological expertise and combine it with our high quality attitude. We manufacture and deliver our client’s products on time!
Biomay addresses clients requiring microbial-based drug substance and drug product for clinical phases I – III and market supply. We have a years-long track record in GMP production of plasmids and recombinant proteins, and since recently, Biomay is a GMP-CDMO for mRNA services.
We operate two fully integrated manufacturing sites, equipped with state-of-the-art bioprocessing facilities. In a number of parallel and independent GMP suites of different scales, all of these clean room classes are available: class D for upstream processing and primary recovery, class C for cell banking and downstream processing, and class A (isolator in C) for aseptic filling.
Biomay’s quality management system is based on ICH and EMA directives (2001/83/EC, 2001/20/EC). The company has been inspected by the U.S. FDA.
