Search results for " facility"
Article
Biosimilars Development and Supply: How Complex Can the Process Be?
We are also leading the way forward to the next generation of biotech manufacturing, which includes a $200-million investment in a new, world-class manufacturing facility in Singapore as part of our “…
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The Development and Application of a Monoclonal Antibody Purification Platform
In some cases, the broth was concentrated before the first chromatography step because of facility fit issues. Protein A chromatography was used in the initial capture step, where the antibody in cell…
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Essentials in Quality Risk Management
Quality risk management is an essential element of every aspect of drug development and manufacturing throughout the product lifecycle.
Quality risk management (QRM), as defined in Internatio…
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QbD and PAT in Upstream and Downstream Processing
Johanning (QAtor): The QbD concept works its way back so to speak from the patient to product to process and ultimately to the facility. A risk assessment will outline the risk profile in and between …
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PDA's Technical Report for Biotech Cleaning Validation
…ogram should include the design of the cleaning process before its implementation in a manufacturing facility. A key to cleaning-process design is an understanding of the cleaning process itself, inc…