Integrated Safety System
Virus Inactivation/Removal & Prion Removal
- Batch Release
Pharmacovigilance & Traceability
After purification, plasma is separated into different plasma therapeutics. Production is controlled through written batch records ensuring each batch of plasma protein therapeutics is made consistently by defined procedures and to approved specifications. Finished therapies are then packaged for distribution, and regulatory authorities check each lot before approving them for release. Only biotherapies meeting all final requirements are approved for release.
All equipment and materials that are reused for processing future batches of products are cleaned, sanitised, and/or sterilised in order to avoid the contamination of subsequently produced batches by residual proteins and pathogens remaining on the material or equipment. The efficacy of the cleaning and sanitisation/sterilisation process is validated (tested for efficacy).
Virus Validation Studies
CSL Behring validates the manufacturing process for the effectiveness of both viral elimination and viral inactivation. All steps in virus reduction are corroborated through virus validation studies. These studies demonstrate and document the capacity of the manufacturing process to inactivate or remove viruses.
Quality Control & Quality Assurance
Quality control measures are operational throughout each stage of manufacturing. These stages include in-process control of product intermediates, filling and packaging, and final product release testing, including stability testing. All processes are further monitored by Quality Assurance auditing.
The elimination and inactivation of viruses in the manufacturing process of products is achieved by a series of measures. It starts with the selection of donors and testing of donations, continues with purification, virus inactivation and elimination and is completed by multiple levels of quality control. Each step of the manufacturing process contributes to the safety of our products. Over the last 25 years, the risk of virus transmission by the application of plasma-derived products has been nearly eliminated.
UK/CORP/11-0061l Date of preparation: Dec 2011