FEIBA Patient Information Booklet - Haemophilia Care

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Protecting patients: the Baxter plasma safety programme In the production of plasma-derived treatments such as FEIBA, patient safety is of paramount importance. By adhering to the most stringent plasma safety regulations, Baxter is exceeding standard industry practices, dedicating efforts to advancing plasma safety. In fact, Baxter is a world leader in all aspects of plasma-derived therapeutic safety from initial donor selection to final product formulation. We source plasma from our own plasmapheresis centres or from centres that meet Baxter standards. Our plasma screening standards meet or exceed all industry and regulatory requirements. As a result, you can be confident that everything possible has been done to ensure the safety of FEIBA. Protecting patients: the Baxter plasma safety programme Our safety measures include • One of the first companies to receive QSEAL (Quality, Standards of Excellence, Assurance, and Leadership) certification which recognises the company’s commitment to outstanding quality and safety in plasma sourcing and manufacturing Strict selection of plasma donors according to the Qualified Donor Standard • All donor applicants have to go through two sets of screening interviews (covering case history, high-risk behaviour inquiry, physical examination) and laboratory tests before being a qualified donor • All donations made by donors that do not come back for a second donation are automatically discarded 60-day inventory hold period of all plasma donations to ensure safety of donation • The inventory hold period allows each donation to be virus-tested (and discarded if positive) before it goes into the manufacturing process • It also gives sufficient time to receive post-donation information about donor and to discard any single donations 18 19
PCR and Serology testing of plasma • PCR testing is performed on sample donations to detect virus genomes • Small samples are pooled and only those that are PCR-negative are allowed to enter the production pool. Positive samples are isolated and destroyed along with any previous samples provided by the donor. The donor is then rejected from future donations • Prior to using a plasma production pool for FEIBA production, further PCR testing is conducted in Baxter’s dedicated Serology laboratories in Vienna NAT (nucleic acid amplification technology) testing for assurance • Allows detection of certain viruses earlier than current serological screening methods Vapour Heat treatment for inactivation of viruses • During the manufacturing process, FEIBA also undergoes a two-step vapour heat treatment which destroys potential viruses without destroying the product Leading the way in patient protection Since the early 1990s, our experts have been leading the way in Plasma Safety, pioneering many key innovations that have increased the quality and safety of plasma products. Many other companies have adopted our plasma inventory hold and Qualified Donor Programme standards. Plasma Master File Baxter collaborated with European authorities to develop the concept of the Plasma Master File, which was officially adopted in 1994. In 2001 Baxter was one of the first companies to receive the Plasma Protein Therapeutics Association (PPTA) certification of compliance with the International Quality of Standards of Excellence, Assurance and Leadership (QSEAL) Program, which recognizes the company’s commitment to outstanding quality and safety in plasma sourcing and manufacturing. Nanofiltration of viruses • As well as vapour heat treatment, nanofiltration takes place during the manufacturing process. Nanofiltration means that in the unlikely event that viruses are still present in the raw material, they will be removed via very fine filters Every stage of the manufacturing process for FEIBA, from donor to patients, is subjected to the most rigorous quality control and quality assurance standards 20 21
Page 1 and 2: Baxter Healthcare Ltd, Wallingford
Page 3 and 4: Introduction to inhibitors Patients
Page 5 and 6: Why is it important that I keep tak
Page 7 and 8: 5 10 15 20 ml Preparing FEIBA for u
Page 9: How should I store FEIBA? FEIBA sho

FEIBA Patient Information Booklet - Haemophilia Care

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