Integrated PrimeSim simulation technology, PrimeTime signoff STA validation and SmartScaling for multi-PVT yields high-quality libraries for faster design convergence PrimeLib ML and advanced ...
Matt Taylor is a senior process development associate at KBI Biopharma, where he focuses on the design, optimization, and scale-up of purification processes for biopharmaceutical manufacturing. Matt ...
Design of experiments enables engineers to demonstrate or understand a process while providing information required for achieving regulatory compliance. A valuable method for predicting process ...
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DUBLIN--(BUSINESS WIRE)--The "Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation): 2-Day Workshop "conference has been added to ResearchAndMarkets.com's ...
Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...
Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...
Process characterization and viral clearance validation are pivotal studies in biopharmaceutical manufacturing, particularly for monoclonal antibodies (mAbs) produced in mammalian systems, which carry ...
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