BioPharm International
September 02, 2020
Cover Story
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Rapid scale-up to billions of doses requires collaborative, all-out efforts by innovators, their manufacturing partners, and the entire supply chain.
September 02, 2020
Peer-Review Research
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The increased use of single-use bags in biologic manufacturing poses the risk of pinholes and other defects that cannot currently be tested for.
September 01, 2020
Downstream Processing
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As technology matures, inefficiencies and process limitations in downstream process chromatography are improved.
September 01, 2020
Manufacturing
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Facility and equipment design are important, but the team and its experience matter most.
September 01, 2020
Quality
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Processes, people, and tools are necessary to comply with the pharmacopoeia and approved drug product registrations.
September 01, 2020
Analytics
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Current and newer biologic modalities pose increasingly complex challenges to the detection and characterization of protein aggregates.
September 01, 2020
Outsourcing
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Cellular and gene therapy fields are currently on track for, if not already experiencing, a serious capacity crunch.
September 01, 2020
Regulatory Beat
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Regulators strive to review flood of advanced treatments while also vetting COVID-19 vaccines.
September 01, 2020
From the Editor
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Amid high expectations for a COVID-19 vaccine, biopharma readies production capacity, weighs external pressures.