New Raw Material Suppliers for Bovine Liquid Plasma
In our ongoing effort toward continuous quality improvement, Proliant Biologicals is pleased to announce the following process improvement.
To support a growing global market and ensure a consistent supply of key raw materials, Proliant Biologicals has approved additional raw material suppliers for liquid plasma to manufacture the following SKU’s at the Boone, IA production facility. The new suppliers have been rigorously tested and validated to ensure no differences in finished products. A summary of the validation is available upon request.
The following SKU’s will utilize our existing and new raw material suppliers:
- 68000 BSA Liquid Standard Grade pH 7.0
- 68100 BSA Standard Grade pH 7.0 Lyophilized Powder
- 68600 BSA Liquid Reagent Grade Fatty Acid Free
- 68700 BSA Reagent Grade, Fatty Acid Free Lyophilized Powder
US (USDA) and EU (European Commission) regulations require only ante-mortem inspection for treated blood products, such as BSA. Historically, Proliant Biologicals exclusively used edible grade plasma, which allowed the company to produce a human nutritional supplement along with Bovine Serum Albumin (BSA). Edible grade plasma has passed both ante- and postmortem inspections. Proliant Biologicals is adding suppliers to ensure the supply of BSA for its customers. The new suppliers for liquid plasma meet the regulatory requirements of ante-mortem inspection to produce BSA and satisfy export/import requirements. Product quality and processes for BSA remain unchanged.
The certificate of origin (COO) for the identified BSA finished products above is being updated to support the additional raw material suppliers, which provide liquid plasma that has passed ante-mortem inspection. For those unique situations where postmortem inspection may be needed by customers, new SKU’s will be created for finished products where the liquid plasma passed both ante- and postmortem inspection.
This change will be effective June 1, 2022 (180 days from the notification date).
These efforts are part of our long-term commitment to quality and reliability as the world’s premier BSA manufacturer. Proliant Biologicals, LLC manufacturing is completely integrated, controlling the entire process from plasma collection through drying and packaging resulting in unprecedented and unmatched control over the quality and consistency of our BSA finished products.
Please contact Proliant Biologicals sales or customer service if you have any questions.