Regulatory Information 

The Proliant Biologicals Facility produces Bovine Albumin (BSA) in adherence to FDA Bulk Pharmaceutical Chemicals cGMPs. The manufacturing of BSA by Proliant is designed to ensure that neither the raw material collection, manufacturing process nor the manufacturing environment introduce any contaminants into the product. Installation, Operation and Process Validations have been performed to ensure that equipment and systems function as intended and produce a consistent, reproducible product that will meet established specifications. All SOPs and batch records demonstrating compliance with BPC cGMPs are on file at the manufacturing site and are available for inspection at an audit.

The bovine plasma used in the production of Proliant albumin is collected in the mid-west of the United States under Proliant control at specially qualified collection sites. We also manufacture material from New Zealand origin. Because of the strong level of control over collection and processing, Proliant has been granted a TSE Certificate of Suitability to the Monographs of the European Pharmacopoeia. Our manufacturing process has also been shown, via a prion clearance study, to eliminate virtually any possibility of TSE contamination. Proliant BSA is also approved under USDA/APHIS inspection to export product to the EU.