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Become a Speaker at PharmaLab 2026 - Analytic, Bioanalytic, Microbiology

PharmaLab 2026 - become a speaker at the leading congress on analytics, bioanalytics and microbiology. Meet over 500 colleagues as part of the speaker team in Darmstadt. We also welcome poster requests.

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Utility of Comparative Efficacy Studies in Biosimilar Development

How and to what extent comparative efficacy studies are useful in the development of biosimilars has been discussed many times. The ICH has now published a concept paper on this topic with plans to publish draft guidelines in 18 months.

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MAT Survey by the British NC3Rs

The British National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs), with the support of other European authorities, the FDA and industry representatives, has published a survey on MAT in pyrogen testing and is calling for participation.

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ATMP Group Developments from May to August 2025

Find out what the ECA ATMP Group was working on and accomplished from May to August of 2025 - in the latest report.

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WHO Guidelines on Reducing Animal Testing

WHO: With the publication of new guidelines, another relevant organisation is now emphasising the importance of the 3R principle in the quality control and quality assurance of biopharmaceutical products. This means that efforts in Europe and, for some time now, in the USA are now also moving in the same direction globally.

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Standardisation of Monoclonal Antibodies (mAbs) by the EPC

In July 2025, the European Pharmacopoeia Commission (EPC) officially completed the pilot phase for the development of public standards for monoclonal antibodies (mAbs). This project, which was launched in 2014, represents a milestone in biopharmaceutical quality assurance. The aim was to develop both product-specific monographs and general chapters in order to standardise common quality attributes of mAbs.

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USP publishes revision of chapter <111> Design and Analysis of Biological Assays

As part of the revision and reorganisation of the USP chapters on biological assays, the USP has now published the draft revision of chapter <111> ‘Design and Analysis of Biological Assays’. The revision was also necessitated by the contents of the new chapter <1034>.

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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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