Search results for "biopharmaceutical"
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
Therapeutic monoclonal antibodies (mAbs) represent a rapidly growing area in the biopharmaceutical sector (2). Enormous success achieved with mAbs can be attributed to their distinctive beneficial pro…
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Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
The good news is that, partly because of the efforts to remove or inactivate viruses, there have been no reported cases of disease transmission from a biopharmaceutical manufacturing process to a pati…
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Microbiological Testing: Time is of the Essence
Challener
Effective microbiological testing during biopharmaceutical drug development and manufacturing is crucial for ensuring sterility, determining antimicrobial effectiveness, detecting microbi…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
…prove recombinant protein production to meet the demands of high quantity and consistent quality of biopharmaceutical products. Those efforts can be categorized into two fundamental areas: improving …
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Tools for Continuous Bioprocessing Development
Would this structure be desirable for biopharmaceutical manufacturing? Although their respective regulatory environments are radically different, the two industries share some common elements: use of …
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Fluid Handling in Biopharma Facilities
By Susan Haigney
Contamination prevention in biopharmaceutical manufacturing is crucial, and the proper handling and storage of fluids is essential to limit the possibility of contamination. Facili…
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2014 Manufacturing Trends and Outlook
In a recent survey of current trends and practices in biopharmaceutical manufacturing, BioPharm International readers revealed a preference for disposable systems, identified challenges for different …
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QbD and PAT in Upstream and Downstream Processing
Girard (Spinnovation): The underlying concept for QbD of an upstream bioprocess is that the desired quality of the biological or biopharmaceutical product is assured every time. CQAs vary for each cel…
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The Importance of Process Intensification and PAT for Achieving Real-Time Release
Lee and Mark Lies
Process intensification is of broad interest in the biopharmaceutical industry because of its promise and potential to increase efficiency and t…
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Jefferson Institute for Bioprocessing Opens Near Philadelphia, PA
…al Institute for Bioprocessing Research and Training (NIBRT), a center for training and research in biopharmaceutical manufacturing based in Ireland. JIB will use the Cytiva FlexFactory Platform to p…