October 02, 2022
Cover Story
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Both demand for and investment in fill/finish capacity continue to rise.
October 02, 2022
Peer-Reviewed Research
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Using a minimum valuable product and process approach would make it is possible to discipline and structure the development of biopharmaceuticals in the fastest way possible.
October 02, 2022
Development
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There are many benefits of employing a reformulation strategy, but companies must also overcome a variety of challenges too.
October 02, 2022
Upstream Processing
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The industry revisits the pros and cons of microbial fermentation at scale for biotherapeutics.
October 02, 2022
Manufacturing
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BFS technology can help maintain sterility during the biologics manufacturing process.
October 01, 2022
Downstream Processing
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A simplified downstream process can save time and costs but requires enabling technologies.
October 01, 2022
Quality/Regulations
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Awareness of recently implemented—or ongoing—advances by the pharmacopoeias can help biotherapeutic manufacturers remain compliant with current requirements.
October 01, 2022
Analytics
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Assessment of peripheral blood protein glycosylation has recently become scalable, providing a new domain for biomarker research.
October 01, 2022
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Technological developments in real-time supply chain operations provide biologics manufacturers with capabilities that go beyond supply chain visibility to tangibly address security and quality challenges.
October 01, 2022
Weighing Up Big Pharma
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Biopharma focuses on streamlining biomanufacturing and supply chain issues to drive uptake of cell and gene therapies.
October 01, 2022
Regulatory Beat
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FDA backs joint reviews, common research policies, and modern production methods around the world.
October 01, 2022
From the Editor
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One can only learn the secrets of "fight club" by attending its meetings.
October 01, 2022
Ask The Expert
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Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, addresses the difference between regulatory compliance and real compliance.
October 01, 2022
From the CEO
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The 1VQ papers advocate for the idea that certain post-approval changes should be streamlined and expedited.