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Publication of three FDA draft guidelines on donor eligibility for HCT/Ps

The FDA has comprehensively updated its guidelines for ensuring the safety of human cells, tissues and cell-based products (HCT/Ps). With a focus on minimising HIV, HCV and HBV transmission risks, the new guidelines rely on more precise testing procedures and uniform, risk-based donor evaluations. These changes represent progress in quality assurance and infection prevention.

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Revision of USP <1085> "Guidelines on Endotoxin Test"

The USP continues to work on updating its chapters around endotoxin testing and is publishing a proposed revision to Chapter <1085> Guidelines on Endotoxin Test.

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Inadequate Classification leads to Warning Letter

An incorrect classification of a biological product led to a Warning Letter from the FDA, even though there was no CGMP violation.

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Warning Letter for an American Manufacturer of Blood Products

The FDA's inspection of a manufacturer of blood products uncovered significant violations of Current Good Manufacturing Practices (CGMP) for blood and blood components, leading to concerns about the safety, purity, and quality of their products. These violations included inadequate staff training, failure to follow procedures, poor record-keeping, and lack of proper investigation into discrepancies.

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Supporting biopharmaceutical Research and Development for Europe

The European Commission has signed a first investment agreement to support biopharmaceutical research and development as part of the HERA Invest initiative. With funding of €20 million, it is supporting the French company Fabentech in the development of therapeutic antibodies against biological health threats.

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Revision of USP Chapter <1047> on Gene Therapy Medicinal Products

USP <1047> Gene Therapy Products - Proposed revision was published in PF 50 (4) by the USP together with a whole series of further updates and revisions.

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USP follows the 3R Principle - Implementation of new Chapter on recombinant Test Methods

The USP follows suit! Following other pharmacopoeias, the USP is now also publishing a chapter <86> on recombinant reagents for testing for endotoxins, thereby following the worldwide endeavour to reduce the use of animal materials.

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FDA Developments on Biosimilars

The FDA has published a comprehensive guidance recommendation to assist biosimilar applicants with manufacturing changes. Through the question-and-answer format, the FDA provides insights and recommendations to promote the development of these important therapeutic alternatives, while also seeking to collaborate with industry to effectively shape future biosimilar guidance.

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Revision of USP Chapter <1033> on Validation of Biological Assays published

Validation of Bioassays - after a rejected attempt to revise Chapter <1033> at the end of 2022, the USP is now publishing a draft revision based on the currently still official version from 2013.

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Next Generation of Genome Editing?

Researchers at the Arc Institute have developed a new genome editing technique that enables DNA rearrangements with greater precision. This discovery, based on the use of a unique "bridging RNA", could radically change the future of genome design. This discovery was recently published in two papers in the journal Nature. How does this new genome editing mechanism work?

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