One-Stop GMP Contract Manufacturing of Biopharmaceuticals
Biomay offers fully integrated good manufacturing practice (GMP) capacities for contract manufacturing of recombinant proteins and DNA plasmids.
cGMP Contract Manufacturing of Plasmid DNA and Recombinant Proteins
Vienna Competence Center,
Lazarettgasse 19
,
1090 Vienna
,
Austria
Biomay is a Good Manufacturing Practice (GMP) contract development and manufacturing organisation (CDMO) for plasmid DNA, messenger RNA (mRNA) and recombinant proteins for clinical phases I-III.
Headquartered in Vienna, Austria, Biomay has manufactured recombinant biomolecules with microbial systems (E. coli, yeasts) for more than 20 years.
Biomay has a particular track record in GMP manufacturing of advanced therapeutic medicinal products (ATMP) such as:
Biomay offers the following GMP contract services:
Biomay manufactures GMP-grade plasmid DNA (pDNA) for third party clients. As a plasmid CDMO, Biomay addresses clients requiring batch sizes ranging from 100mg to 20g.
Biomay´s plasmid DNA technology features:
Biomay offers these quality levels for plasmid manufacturing:
Biomay`s GMP facility consists of the following areas:
The complete processing chain for microbial biopharmaceuticals is established. Biomay caters to:
Upstream
Midstream:
Downstream (purification):
Enzymatic processing of DNA:
Filling and finishing (partially with subcontracting partners):
Analytical testing and in-process controls conforming with United States Pharmacopoeia (USP) / European Pharmacopoeia (PhEur) standards are offered. Assay development, validation and stability testing can be performed. Biomay employs a certified QP for internal drug product release.
Established analytical methods:
Biomay offers fully integrated good manufacturing practice (GMP) capacities for contract manufacturing of recombinant proteins and DNA plasmids.
Biomay is pleased to announce that it is building a new production facility, which will expand its production capacities tenfold and its headcount almost double.
Vienna Competence Center
Lazarettgasse 19
1090 Vienna
Austria