News

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.

More
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.

More
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.

More
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.

More
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>.

More
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.

More
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.

More
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.

More
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.

More
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.

More
x
Search