Articles in this Issue

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  The Use of Mycoplasma Reference Standards in the Light of the Revised Ph. Eur. 2.6.7

  On 1 April this year, the Ph. Eur. Chapter 2.6.7, in its thoroughly revised form, came into force. It applies to medicinal products derived from or manufactured using living cells or biological systems and that have a realistic risk of contamination by Mollicutes (including the genus Mycoplasma).
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  The Misuse of Most-Probable Number in ‘Rogue’ BI Remediation

  Use of MPN for resolution of anomalous results assumes a log-linear death curve, which has never been established in a bi-phasic system.
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  Lyophilization and Next-Generation Therapeutics: The Challenges of Scaling Up

  Lypophilization helps stabilize fragile new modalities, including messenger RNA and the advanced formulation vehicles that deliver them.
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  Rethinking ADC Payloads From Cytotoxics to Targeted Small Molecules

  Many patients abandon ADC therapies due to the associated toxicities. The next major leap requires designing targeted small molecules for conjugation.
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  The GLP-1 Boom is Great for Everyone Except Pharma Safety Teams

  GLP-1s have generated large amounts of new safety work. Pharmacovigilance systems are struggling to cope with the volume and complexity.
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  The Asymmetry Advantage: Why Early Chiral Strategy Determines API Success

  Chromatography has an important role, but relying on it too long may cost of goods, extend timelines, and complicate regulatory submissions.