Central Biomedia, Inc. (CBI) operates two separate facilities, a donor horse operation in Irwin, Missouri and a facility for FDA-registered contract manufacturing of serum under private label in Lenexa, Kansas. Our two facilities allow us to provide a wide range of services to our customers, and as founding members of the International Serum Industry Association (ISIA), both our facilities are proud to be ISIA Traceability Certified. What’s more, both are USDA EU 142/2011 approved to export blood products to the EU.
Since we first opened our Lenexa location in 1992, we’ve nearly doubled in size and we’re still growing! As an FDA-registered contract manufacturer of in-vitro diagnostics (Class 1 Medical Devices) and a USDA-licensed veterinary biologics manufacturing site, our Lenexa facility processes serum strictly under private label. In order to accommodate the requirements of producing a variety of sera for diverse customers, we maintain two large 2500 liter stainless steel serum tanks dedicated to serum of US origin, as well as a 1600 liter stainless steel tank for serum of non-US origin.
The Lenexa facility houses sterile filtration production rooms, a quality control laboratory, on-site autoclave and dry heat oven, administrative offices, large self-contained freezers and coolers, as well as warehouse space and shipping and receiving areas.
Irwin (“The Farm”)
Our farm facility in Irwin, Missouri maintains the largest true donor horse serum herd in the United States. The 7500 square foot serum processing facility includes an enclosed bleeding area, two walk-in coolers and a walk-in freezer, a controlled environment with laminar air flow for serum processing, and equipment wash areas. The serum processing facility may be the heart of the farm, but it’s only a part of what our Irwin facility houses. Our on-site donor herd of almost 200 horses is carefully maintained in accordance with best management practices to assure uncompromised serum consistency and quality, overseen by an on staff Doctor of Veterinary Medicine. Our horses are important to us, so in addition to a consistent and controlled dry lot diet to ensure serum quality, we also make sure that they get top-notch medical care, plenty of open space, and are as contented and healthy as possible.
One of the advantages of selling our own donor horse serum is that keeping our own herd allows us to provide an unprecedented level of traceability. Our donor horse serum is traceable to the individual animal, allowing us to provide our customers with the flexibility to customize our end product to almost any need.