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Manufacturing Perspectives: Lessons for Biomanufacturing from Small-Molecule Manufacturing
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Lou Schmukler
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A perspective from Pfizer on the lessons from small-molecule manufacturing that can be applied to biomanufacturing.
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Building Technology Positions in API Manufacturing
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Patricia Van Arnum
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As contract manufacturers and fine-chemical suppliers gather for CPhI/ICSE, effective strategies for technology differentiation are key in an increasingly competitive environment.
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FDA's New Process Validation Guidance: Industry Reaction, Questions, and Challenges
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Mike Long
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Hal Baseman
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Walter D. Henkels
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The authors desribe the three-stage approach to validation that is outlined in the new guidance and discuss questions surrounding implementation.
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The Determination and Control of Genotoxic Impurities in APIs
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V. Gangadhar
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Y. Pardha Saradhi
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R. Rajavikram
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The authors provide an overview of methods for the quantitative determination of genotoxic impurities (GTIs) in active pharmaceutical ingredients.
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Sample Preparation for Quantitative Metal Impurity Testing
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Gayla Velez
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The author examines sample-preparations methods used in inductively coupled plasma–optimal emission spectroscopy for four test metals.
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Achieving Containment in High-Potency Manufacturing: A Case Study for Solid Dosage Manufacturing
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A Q&A with Joe Cascone, director of potent pharmaceutical development at Metrics, moderated by Patricia Van Arnum. Discussion of the key considerations made in facility design, equipment selection, and operations to achieve desired levels of containment.
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A Supplier's Role in Ensuring and Improving Excipient Quality
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Frithjof Holtz
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Najib Sehat
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Excipients are the hidden champions of drug development—no API works consistently without the right excipient. Pharmaceutical excipients, however, require stringent quality management. This article discusses how the supplier of pharmaceutical raw materials should take a central role in ensuring excipient quality.
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Addressing Ways to Improve Supply-Chain Security: A Perspective from Pfizer
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A Q&A with Brian Johnson, senior director of supply chain security at Pfizer, moderated by Patricia Van Arnum. Part of a special Ingredients issue.
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Atypical Actives Gain Attention
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Angie Drakulich
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Clarifying GMPs for excipients used as actives.
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