Plasma Therapies & Vaccines
Safety & Manufacture Of Plasma Therapies
Every medicine possesses some level of safety risk. For plasma - derived therapies, the most important safety issue is the potential for contamination with pathogens originating from the plasma used to manufacture these therapies. Although the theoretical risk of pathogen transmission can never be zero, we use multiple and overlapping safety measures to reduce this risk to as low as is technically feasible. Since the introduction of dedicated virus reduction and removal steps and thorough quality assurance measures in plasma fractionation, there have been no reports of proven transmission of a pathogen via a plasma - derived therapy manufactured by CSL. For more on safety see CSL Behring’s Commitment to Safety and Quality
Safety & Manufacture Of Vaccines
Each year, the World Health Organization (WHO) Global Influenza Network provides CSL with influenza virus samples, which represent the influenza strains predominating in the southern and northern hemispheres. The WHO and local regional authorities then make recommendations for the composition of the vaccine for the southern and northern hemispheres respectively. This ensures that the influenza strains in the vaccine match as closely as possible with the viruses that are likely to circulate in the following southern and northern hemisphere winters.
Our production plants are maintained at the highest standard and are subject to regular inspections by regulatory authorities, including the Australian Therapeutic Goods Administration (TGA) and the US Food and Drug Administration (FDA). CSL’s Seqirus division is one of the largest influenza vaccine companies in the world and utilises both egg and cell-based production technologies, producing a broad portfolio of inactivated influenza vaccines. CSL’s egg-based influenza vaccine is an inactivated vaccine – i.e., it does not contain live influenza virus. The production process involves the use of validated procedures to chemically inactivate the virus. The safety and effectiveness of our influenza vaccine has been documented extensively in clinical studies conducted in healthy volunteers and from post marketing surveillance in the community.