GMP News - Blood / Biologics and ATMP

31.01.24

EMA publishes new questions and answers on Annex 1

At the beginning of 2024, the EMA added 4 new questions and answers to its catalogue of frequently asked questions from the GMP and GDP area.

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21.11.23

WHO Draft Working Document on Bioanalytical Method Validation published for Comments

The World Health Organization (WHO) has published a draft working document entitled Bioanalytical Method Validation and Study Sample Analysis (QAS/23.925). Comments should be submitted by 21 January 2024.

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02.11.23

EDQM's new Reference Substance for Hepatitis C Virus

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".

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02.11.23

New Guideline on Haemotherapy

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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02.11.23

EMA revises Guidance on Development, Production, Characterization and Specification for Monoclonal Antibodies and related Products.

In the context of technical and scientific developments in the field of certain products containing monoclonal antibodies, the EMA is revising its guidance document "Development, production, characterisation and specifications for monoclonal antibodies and related products" and other related documents.

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02.11.23

USP Briefing on Mass Spectrometry-Based Multi-Attribute Method for Therapeutic Proteins

Publications in the'USP Proposals PF 49_5 also include a draft chapter <1060> "Mass Spectrometry-Based Multi-Attribute Method for Therapeutic Proteins".

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05.10.23

BfArM/PEI: Guideline "Designation of Medicinal Products" published

The German BfArM (Federal Institute for Drugs and Medical Devices) and the German PEI (Paul Ehrlich Institute) published version 8.2 of the guideline on the designation of medicinal products at the end of July, which can be viewed on both websites of the institutes. The above-mentioned guideline was fundamentally revised in 2023 and applies exclusively to medicinal products for human use. It is intended to support marketing authorisation holders and applicants in the selection of the designation of the respective medicinal products.

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05.10.23

EMA's Questions and Answers on the Biological Medicines Marketing Authorisation Dossier Published

Biological medicinal products are gaining more and more interest. Due to the ever increasing complexity and diversity within these medicinal products, more questions arise. The EMA has now published a Q&A document to support the marketing authorisation holders presenting the information in the dossier correctly.

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13.09.23

FDA Recommendations regarding CGT Products

The FDA has published its considerations regarding CGT products in a new draft guidance. The purpose of this guidance is to provide recommendations for managing manufacturing changes and assessing comparability for both investigational and approved human CGT products, taking into account the unique challenges that apply to these products.

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12.09.23

Publication of EMA Document on the Establishment of a Guideline on mRNA Vaccines

More and more authorities are trying to create regulations for the production of new technologies by publishing guidelines. In this case, the European Medicines Agency (EMA) is asking for assistance in developing a guideline on the manufacturing of mRNA vaccines.

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06.07.23

2nd Version of the USP Draft Guidance on mRNA-based Therapeutics

Because the application of mRNA technology is relatively new, regulatory guidelines and industry standards to govern non-compatible aspects of mRNA quality during development and manufacturing are still evolving. The USP has now defined standards and is seeking input during the comment period on a new draft guidance version for the analysis of mRNA.

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06.07.23

Artificial Intelligence/Machine Learning in the Analysis of Biotherapeutics

The complexity of therapeutic protein-based medicinal products makes characterisation of these products difficult. However, the use of artificial intelligence and machine learning in flow imaging microscopy opens up new possibilities.

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06.07.23

Potential Assays for Monoclonal Antibodies and Other Therapeutic Proteins

The FDA recommends and provides guidance on potency assays for monoclonal antibodies and other therapeutic proteins that directly target viral proteins or host cell proteins that mediate pathogenic mechanisms of infection. The purpose of this FDA guidance is to assist in the development and implementation of such assays to ensure adequate information on efficacy throughout the shelf life of the product.

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01.06.23

Guidance on the Identification of Medicinal Products

With the guidance "Identification of Medicinal Products - Implementation and Use" published in March, the FDA addresses all those involved in the submission of medicinal product data.

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01.06.23

FDA Recommendations to reduce HIV Transmission through Blood and Blood Products

The FDA has revised the guidance regarding recommendations for blood establishments to defer donors for persons with an increased risk for human immunodeficiency virus (HIV) transmission.

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