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Central Biomedia, Inc: Quality and Service
Central Biomedia, Inc. (CBI) began in 1985 producing and marketing bulk donor animal serum in Irwin, Missouri. In 1992, CBI opened an additional facility in Lenexa, Kansas, for the production of private labeled, contract manufactured, animal serum for the biotechnology industry. In 1994, CBI started a subsidiary, Sera, Inc., to manufacture and market biologicals for the veterinary industry. In 2006, CBI became a founding member of the International Serum Industry Association (ISIA).
Central Biomedia, Inc.'s two facilities, Lenexa and Irwin, have two separate functions. Our Lenexa facility is FDA-registered for manufacture of Class I medical devices for in vitro diagnostics. It also has a USDA Veterinary Biologicals Establishment License as well as being an approved USDA quarantine holding facility for imported ruminant serum. In addition, this facility has been granted approval number KS-TEC-0001 by USDA, National Center for Import/Export (NCIE), allowing manufactured products to be exported into EU countries in compliance with current EU Regulations.
All bulk donor serum is collected at our collection and processing facility in Irwin, Missouri. This facility is also a USDA-licensed veterinary biologicals establishment with active licenses to produce bulk sera for further manufacture. This facility has been granted approval by the USDA, NCIE as a collection site for bovine and equine serum in compliance with current EU regulations. This approval allows export into EU countries under approval number MO-TEC-0001.
The donor herds are maintained in accordance with carefully controlled management practices to assure uncompromised serum consistency and quality.
Central Biomedia, Inc. has undergone significant changes and improvements to underscore our commitment to all facets of the manufacturing of animal serum products.
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