PAA`s production facilities are fully compliant with current Good Manufacturing Practices (cGMP) operating under a pharmaceutical grade licence. PAA controls all processes from raw material collection through to final sterile filtered product guaranteeing full product vertical integration. The supply chain follows our strict quality control standards and regular audits are performed to ensure all procedures are within our quality assurance standards. Constant monitoring of all processes ensures that only products of the highest quality with batch to batch consistency are manufactured by PAA.

Origin

PAA collects raw serum from both United States Department of Agriculture (USDA) and European (EU) approved sources. Both high quality and biological safety are key factors along with traceability and documentation control. PAA can offer its customers fully documented serum products from Australia, USA, Canada and Central America which are all USDA approved origins. For customers not requiring USDA sourced sera then EU approved versions are available. PAA holds several Certificates of Suitability (CoS).

Manufacturing

To fulfil the increasing demand for sera, particularly from the industrial market, PAA has opened production sites in Australia (Brisbane) and Canada (Toronto) to complement its ‘state of the art’ production facility in Austria (Linz). Therefore, raw material collection through to the final sterile filtered product is performed locally. All PAA production sites operate under cGMP guidelines.

Production

To standardize production processes, all PAA production sites are controlled by the same documented and controlled SOP's. Raw material is filtered under temperature controlled (cooled) conditions through a filter cascade process down to triple 100nm size filters. The maximum batch size is presently 2.600 litres. Throughout the full production process in-line monitoring and testing ensures that only high quality serum products are released for sale to our customers. Batch process and production records are prepared along with all other necessary documents including a comprehensive Certificate of Analysis (CoA).

Test samples, Reservations and Orders

Many customers prefer to test serum products with their respective cell lines in line with their in-house requirements. PAA will provide samples from different batches for customer testing and will hold the requested numbers of bottles from each batch on reservation until sample tests are completed. Normally reservations are held for 4 weeks. Please advise PAA if longer reservation periods are required.

For those customers placing orders, who do not have sufficient storage space, PAA can store their serum in controlled freezer rooms for future ‘call off’ or ‘sold and storage’ orders. For full details on these please contact PAA.

Storage, Shipping and Logistics

All sera are stored in ≤ -15°C controlled freezer rooms at PAA facilities.

Serum should be shipped frozen at this temperature. PAA ships all serum products in styrofoam boxes containing sufficient solid CO2 (dry ice) to maintain frozen conditions during shipment. Upon receipt please place all sera products in a £ -15°C freezer.