Clinical Manufacturing | two BSL-II/ ML-II GMP facilities for manufacture of drug substance, drug product

Batavia Bioservices operates two independent BSL-II/ ML-II GMP facilities for the manufacture of drug substance and/ or drug product:

  1. The first facility (120 m2) consists of a separate cell culture area and two separate class C production suites and two separate downstream clean rooms. Also, separate media/buffer prep, MCB storage and QC areas are present. The facility is currently equipped to run up to 50 Liter mammalian fermentation processes or 20 Liter microbial fermentation processes.

  2. The second facility (100 m2) consists of a separate pre-culture area; one Class C production suite and one downstream clean room with separate areas for buffer/ media preparation. The facility is equipped to run up to 100 liter mammalian fermentation processes.

Batavia Bioservices thus provides to its customers the manufacture of Master Cell banks/ Working Cell Banks & Master Virus Seeds/ Working Virus Seeds. The company also offers clinical production and release of proteins, antibodies, vaccines and vectors produced in diverse formats (Stainless steel bioreactors, spinner flasks, shake flasks, etc).

Clinical Manufacturing | two BSL-II/ ML-II GMP facilities for manufacture of drug substance, drug product
Clinical Manufacturing | two BSL-II/ ML-II GMP facilities for manufacture of drug substance, drug product