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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.

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.

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.

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.