BioPharm International
June 02, 2021
Cover Story
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The emergence of new biotherapeutics is both the driver and result of innovative drug development technologies.
June 02, 2021
Peer-Reviewed Research
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Controlling certain atmospheric conditions in a closed NGI processing chamber can reduce bioburden without disinfectants.
June 02, 2021
Development
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Contract manufacturers play a key role in the production of lipid nanoparticles for RNA vaccines.
June 02, 2021
Upstream Processing
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Cell-free expression is promising in preclinical applications, but still presents challenges to scale up for commercial production.
June 01, 2021
Downstream Processing
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Recent innovations in chromatography resins offer promising advantage in downstream bioprocessing.
June 01, 2021
Manufacturing
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Digitalization of bioprocessing operations, equipment, and facilities can improve workflow and output, but maintaining data integrity is a concern.
June 01, 2021
Manufacturing
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Container and equipment innovations expand applications.
June 01, 2021
Analytics
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The increased number of regulatory filings for cell and gene therapies requires reevaluation of bioassay methods because of their complexity.
June 01, 2021
Outsourcing
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Outsourcing method development offers multiple benefits to companies, including access to experience and expertise, streamlined costs, and development time efficiencies.
June 01, 2021
Regulatory Beat
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Expanded interest in advanced drug manufacturing and continuous production methods calls for more flexible production systems and regulatory policies.
June 01, 2021
From the Editor
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Bio/pharmaceutical manufacturers have made a good first step toward global vaccination through pledging doses at no- to low-profit rates.
June 01, 2021
From the Chairman
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Innovation drives the development of emerging drug modalities.
June 01, 2021
Ask The Expert
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Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about regulatory filings.