Regulatory Information
The Proliant Biologicals Facility
produces Bovine Albumin (BSA)
in adherence to
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 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 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.