cGMP Contract Manufacturing Services

Biomay offers cGMP contract manufacturing services for the production of recombinant biologicals as active pharmaceutical ingredients (APIs). Biomay´s multi-product GMP facility allows the manufacturing of microbial-based biopharmaceuticals like recombinant proteins, allergens, antibody fragments and plasmid DNA (DNA vaccines). Production of recombinant proteins with Escherichia  coli as expression host has ever been Biomay´s core focus and key expertise. In addition, the capacities and know-how for processing of other bacterial hosts or yeasts like Pichia pastoris  are available.  

As a Contract Manufacturing Organization (CMO), Biomay´s goal is to offer a highly attractive price-performance ratio for its clients. Biomay´s ideal production scale is in the magnitude of multiple grams of clinical-grade recombinant protein or plasmid DNA.

Biomay´s quality management system conforms with the international GMP regulations. Biomay has been certified by the Austrian authorities (AGES) according to the EU directives (2001/83/EC, 2001/20/EC) and the Austrian medicinal product act (§ 63 AMG).

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