Several alternative and rapid microbiological methods (ARMM) are now available to detect and enumerate microbiological contamination. Regulatory authorities are encouraging the biopharmaceutical industry to adopt these innovative technologies – but the path is sometimes clouded. Although there are some guidance documents available, a holistic description of the entire end-to-end implementation process is still missing. This is why BioPhorum has...
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Raw material variability and control in the supply chain are important matters for the biopharmaceutical industry. The industry is still working to align the supply performance with biopharma’s needs. More still needs to be done to understand, monitor and control of raw materials. Patient well-being is best assured by reducing or eliminating variability of the finished drug product, and this can be achieved, in part by targeted reduction and/or elimination of variation in raw materials. This paper identifies ten areas of practice endorsed by leading global biopharmaceutical manufacturers to start to address and reduce raw material variation through our supply chains.