BioPharm International
June 02, 2019
Regulatory Beat
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CDER’s KASA program seeks manufacturer data on drug attributes and risks to inform oversight.
June 01, 2019
From the Editor
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FDA’s annual manufacturing report card shows more quality compliance is needed.
June 01, 2019
Features
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The learning curve for process analytical technology has slowed widespread adoption.
June 01, 2019
Features
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As cost and time pressures within biopharma are on the rise, innovative expression systems may offer companies a good opportunity to streamline processes early on.
June 01, 2019
Features
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Proactive approaches that consider long-term supply chain security compliance are recommended to ensure companies stay on the right track.
June 01, 2019
Ask the Expert
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A good working relationship between sponsor and contractor will become invaluable when an OOS occurs, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
June 01, 2019
Features
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Quality by design brings both challenges and benefits to the development of downstream processes.
June 01, 2019
Features
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BioPharm International speaks with several experts to learn more about pipeline platforms and technologies.
June 01, 2019
Issue PDF
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Click the title above to open the BioPharm International June 2019 issue in an interactive PDF format.
June 01, 2019
Peer-Reviewed Research
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The authors present a risk analysis of the impact of various business and operating risks on three facility layout strategies.
June 01, 2019
Features
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Making siloed data accessible across functions and to contract partners is the first step to facilitating continuous improvement and enabling use of artificial intelligence in manufacturing.
June 01, 2019
Features
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Stuart Jones, regulatory quality assurance professional in good laboratory practice (RQAP-GLP) and director of quality assurance at PPD Laboratories’ Bioanalytical Laboratory shared GLP best practices with BioPharm International.
June 01, 2019
Cover Story
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Research advances have enabled the application of nanotechnology to drug delivery. What does this technology offer in the way of enhancing therapeutic effect?
June 01, 2019
Features
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6
This article explores the challenges and potential of next-generation therapeutic antibodies.