Our commitment to quality and safety is the most important aspect of Pioneer Life Science's philosophy. Our manufacturers have invested millions of dollars to establish standards designed to better serve you and your patients. Examples of this effort include the creation of an extensive network of donor collection centers, and the employment of pasteurization,* one of the most reliable virus inactivation processes.
Today, the majority of therapeutic protein companies have agreed to follow a voluntary safety protocol developed by the former American Blood Resources Association (ABRA) and the Plasma Protein Therapeutics Association (PPTA), currently known as PPTA Source. This protocol, called the Seven Steps of Safety, includes standard safety measures designed to reduce the potential for viral transmission in plasma-derived products.
Pioneer Life Sciences understands that the quality of plasma-derived products starts with the source material. Our plasma-derived products begin at collection centers strategically located in the United States. These collection centers are certified through the PPTA Source iQPP.
The standards that must be met to become a plasma donor are rigorous. Before being considered as a donor, applicants are checked for eligibility in accordance with strict criteria. These include proof of identity, background checks, medical history, lab tests, physical examinations, weight and significant health factors.
Plasma samples are shipped from collection centers to a Central Testing Laboratory where they undergo extensive viral testing. This testing is conducted by a team of experienced, skilled personnel using advanced computer technology. This helps to give our customers confidence, because it is designed to ensure that we are continuously following samples for added safety.
These trained technicians perform all government-mandated tests of samples. In addition, they go beyond these government requirements and perform further tests for the presence of other potentially influential factors.
Following serology testing, plasma units that have tested negative in the initial screening are shipped via refrigerated trucks to the Plasma Logistics Center™. This center is a temperature-controlled facility where plasma donations are held in inventory for a minimum of 60 days. The manufacturer uses this waiting period to test a second set of plasma samples from the same donor in an effort to confirm the viral safety of the plasma.
Pasteurization is a heat treatment in solution process that has been used in the manufacture of plasma-derived products.
Throughout the production process, checks are made that are designed to ensure compliance with current Good Manufacturing Practice (cGMP) standards. Each batch of final product undergoes tests designed to confirm its identity, strength, quality, and purity. Product is released only after these checks and tests are completed.
As with all plasma-derived products, the risk of transmission of infectious agents, including viruses, cannot be completely eliminated.
*Heat Treatment in aqueous solution at 60°C for 10 hours.
