BioPharm International-12-01-2018

BioPharm International

Investigation Timeliness vs. Thoroughness: Finding the Right Balance

December 01, 2018

Ask the Expert

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A required time frame should not be the driving force behind root cause investigations, says Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates.

Overcoming Challenges in ADC Bioconjugation at Commercial Scale

December 01, 2018

Features

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Bioconjugation requires aseptic manufacturing and containment for cytotoxic payloads.

BioPharm International, December 2018 Issue (PDF)

December 01, 2018

Issue PDF

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Click the title above to open the BioPharm International December 2018 issue in an interactive PDF format.

Bringing Quality into the Forefront

December 01, 2018

From the Editor

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Innovation may capture headlines, but quality programs are the foundation to biopharma success.

Quality Manufacturing Key to Reducing Drug Shortages

November 29, 2018

Regulatory Beat

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Despite ongoing efforts to address the problem, FDA now sees a rise in active shortages and in the duration of supply problems.