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USP Chapter <1049.1> Stability Studies for Biotechnological and Biological Products

Biotechnologically manufactured drugs - known as biologics - place high demands on stability testing due to their molecular complexity. Chapter <1049.1> of the US Pharmacopeia (USP) was written as a supplement to Chapter <1049> and provides detailed recommendations on the design, conduct and adaptation of stability studies throughout the entire product life cycle. The aim is to create a scientifically sound, regulatory-accepted and risk-based strategy for validating and controlling the shelf life and storage conditions of such products.

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USP veröffentlicht Revision der Kapitels <111> Design and Analysis of Biological Assays

Im Rahmen der Überarbeitung bzw. Neuaufstellung der USP-Kapitel zu biologischen Assays hat die USP jetzt den Überarbeitungsentwurf des Kapitels <111> "Design and Analysis of biological Assays" veröffentlicht. Die Revision wurde auch durch die Inhalte des neuen Kapitels <1034> notwendig.

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Microbiological Updates of the Pharmacopoeias

Various pharmacopoeias are currently revising chapters relevant to microbiology. This affects various areas, from rapid methods to potency determination for phage therapies, which is located in many microbiology departments.

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ATMP Group Developments from January to April 2025

Find out what the ECA ATMP Group was working on and accomplished in the first four months of 2025 - in the latest report.

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FDA Initiates Transition to Non-Animal Testing Methods for Monoclonal Antibodies

On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a significant policy shift aimed at reducing and potentially eliminating the requirement for animal testing in the development of monoclonal antibodies and other drugs. This initiative seeks to enhance drug safety, accelerate the evaluation process, and reduce research and development costs by incorporating human-relevant testing methods.

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EMA Proposes Revisions to GMP Guideline for ATMPs

On May 8, 2025, the European Medicines Agency (EMA) released a concept paper proposing revisions to Part IV of the EU Guidelines on Good Manufacturing Practice (GMP) specific to Advanced Therapy Medicinal Products (ATMPs). This initiative aims to align ATMP-specific GMP requirements with recent updates in sterile manufacturing and to incorporate advancements in technology and quality management systems.

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Microbiology - EDQM asks for Comments on the new or revised Chapters

Chapters with microbiological relevance are currently being published or revised in a whole series of pharmacopoeias. Chapters on rapid methods, pyrogenicity and endotoxin testing are also currently published for comment in the European Pharmacopoeia.

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Become a Speaker at PharmaLab 2025 - Analytic, Bioanalytic, Microbiology

PharmaLab 2025 - become a speaker at the leading congress on analytics, bioanalytics and microbiology. Meet over 500 colleagues as part of the speaker team in Neuss/Düsseldorf. We also welcome poster requests.

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FDA leitet Übergang zu tierversuchsfreien Testmethoden bei mAbs ein

Am 10. April 2025 kündigte die US-amerikanische Food and Drug Administration (FDA) eine bedeutende Änderung ihrer Richtlinien an, die darauf abzielt, die Anforderungen an Tierversuche bei der Entwicklung von monoklonalen Antikörpern und anderen Arzneimitteln zu reduzieren und möglicherweise ganz abzuschaffen. Diese Initiative soll die Arzneimittelsicherheit verbessern, den Evaluierungsprozess beschleunigen und die Forschungs- und Entwicklungskosten durch den Einsatz humanrelevanter Testmethoden senken.

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Development of a Risk-based Quality System for CMC R&D Laboratories in Drug Development

Drug development requires extensive knowledge, especially in the CMC area, to optimize manufacturing processes, ensure product stability and meet regulatory standards. While there are clear regulatory requirements for CGMP activities, specific guidelines for non-CGMP studies in R&D laboratories are lacking. An article in the Journal of Pharmaceutical Sciences presents a risk-based quality system to help companies ensure the reliability, traceability and regulatory usability of R&D CMC data.

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