BioPharm International
December 02, 2020
Cover Story
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A holistic approach to validation and quality assurance is essential.
December 02, 2020
Development
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Analytical and functional characterization of virus-like particles enables process reproducibility and product consistency.
December 02, 2020
Upstream Processing
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Establishing an automated inline dilution system can potentially ease bottlenecking delays resulting from higher upstream yields.
December 02, 2020
Downstream Processing
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Viral clearance processes and guidance must evolve along with newer biotherapeutic modalities.
December 01, 2020
Manufacturing
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The industry is moving beyond cleaning’s “low tech” image to embrace science-based limits and statistical approaches to control.
December 01, 2020
Analytics
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New advancements in lab data management technologies include devices with a fully integrated SDMS, a cloud-based and an online ELN, an ELN featuring a virtual assistant, and updated LIMS software.
December 01, 2020
Operations
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Scaling needs for potential COVID-19 vaccines depend not only on capacity, but also on supply chain challenges and technological hurdles.
December 01, 2020
Regulatory Beat
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Manufacturers and regulators accelerate R&D and production of new vaccines and therapies.
December 01, 2020
From the Editor
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After a difficult year, biopharma science delivers promising results.
December 01, 2020
Ask The Expert
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Virtual audits, virtual training, and more robust quality agreements may become positive impacts on the industry, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.