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06.03.2025 The US Food and Drug Administration (FDA) has criticised a manufacturer of biologicals for significant violations of current Good Manufacturing Practices (CGMP) following an inspection. The company is accused of manufacturing and distributing unauthorised biological products. |
26.02.2025 United States Pharmacopoeia publishes an overview of the effects of the revision of Chapter <1071> “Rapid Microbial Tests for Release of Sterile Short-Life Products: A Risk-Based Approach” on other USP chapters and guidance documents. |
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22.01.2025 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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30.10.2024 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. |
24.10.2024 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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24.09.2024 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. |
05.09.2024 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. |
05.09.2024 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. |
05.09.2024 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? |
05.09.2024 At the end of May, the EU member states adopted the new SoHO Directive, meaning that transposition and implementation of the regulations on substances of human origin (SoHO) are continuing. Find out what the regulation contains and what the next steps are. |
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05.03.2024 Due to ignorance of the FDA definition of drugs, a US pharmaceutical company has received a Warning Letter regarding their products. |
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02.11.2023 Following the successful completion of the Biological Standardisation Programme study to establish Hepatitis C Virus (HCV) Biological Reference Preparation (BRP) batch 2 for nucleic acid amplification techniques (NAT), the result has been published in the online journal Pharmeuropa Bio & Scientific Notes: "Establishment of Ph. Eur. Hepatitis C Virus RNA for NAT assays BRP batch 2". |
02.11.2023 In cooperation of the German Medical Association and the German Paul-Ehrlich-Institut, the existing guideline on haemotherapy for the collection of blood and blood components and the use of blood products has been adapted according to the latest legal, political and scientific status. |
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