Biomay AG is a CDMO specializing in the GMP production of messenger RNA, plasmid DNA, and recombinant proteins. Services include manufacturing of cell banks, process development in a specialized MSAT department, analytical method development and validation, as well as process validation. An automated aseptic filling line enables Biomay to offer clients a complete solution from clinical phases I-III to market supply—all from a single source.
R&D:Biomay is developing manufacturing processes and analytical methods for their clients in the context of a GMP manufacturing project for starting materials and APIs to be used in clinical studies or for market. For their own off the shelf products (Viral Vector Plasmids for AAV or Lentivirus, Cas9 Nuclease, mRNA) Biomay is actively devloping processes and analytical methods.
Production:Biomay operates two multi-product facilities in Vienna, with a total floor space of over 8000sqm. The sites house multiple clean-rooms for GMP manufacturing. Bioreactor scales for microbial fermentation are 5L (multiple), 50L, 150L and 750L. A dedicated personalized facility allows parallel manufacturing of four batches for patient-specific small batches. Capacities for aseptic filling are up to 1500 vials.
Services:Biomays services include vector development (for plasmids, proteins and mRNA), GMP cell banking (Master Cell Bank, Working Cell Bank), process development and feasibility studies, analytical development / quality control methods, GMP manufacturing of bulk drug substance (clinical phases I – III, market supply), GMP aseptic filling of drug product (clinical phases I – III), quality control and Qualified Person release, analytical method and process validation (PPQ).
Sales/Distribution:Besides custom manufacturing for client projects, Biomay is marketing off the shelf products. These include starting plasmids for AAV and Lentivirus manufacturing, Cas9 Nuclease for gene-editing as well as mRNA, all in GMP grade.