GMP Manufacturing
Biomay has been active and successful as a GMP-CDMO since 15 years meanwhile. 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 we have recently stepped into the mRNA processing field.
We operate a new and fully integrated manufacturing building, 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 and recovery, C for downstream and class A/B for aseptic filling.
Biomay’s quality management system is based on ICH and EMA directives (2001/83/EC, 2001/20/EC).