GMP News - Blood / Biologics and ATMP

08.12.20

FDA - Notification of Deviations in Cell and Tissue Products

An FDA document on Biological Product Deviation refers to products based on human tissues or cells.

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08.12.20

New FDA Guidance on Cellular and Tissue Products (HCT/Ps) published

During  2020, the FDA updated and expanded its series of guidelines on the topic of cell and tissue products with a revised version of the Guideline Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use.

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08.12.20

FDA publishes Information and Reviews of Biological Research Projects

In addition to the publication of a large number of guidelines and supporting documents in the field of cell and tissue products, the FDA also provides insights into the biological research projects of its scientists on its website.

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08.12.20

FDA explains Background of Emergency Use Authorizations related to COVID-19 Vaccines

Recently, the FDA published a Q&A Paper on their website that answers the most common questions about the emergency approval of COVID-19 vaccines and explains the underlying process.

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25.11.20

EMA - Public Meeting on COVID-19 Vaccines

Due to the great public interest and the varied discussions, EMA organises a public meeting on Covid-19 vaccines and the role of EMA in the approval process, which all interested citizens can attend via live broadcast.

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15.07.20

FDA Warning Letter due to Lack of Validation of the Aseptic Manufacturing Process

In this Warning Letter from the FDA to a manufacturer of unauthorised tissue-based products, deficiencies in current Good Tissue Practice (cGTP) and violations of fundamental GMP regulations are described. 

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02.06.20

FDA expands Guideline Activities around Gene Therapies

With the publication of six final guidelines on gene therapies and one additional draft guideline, the FDA is further expanding its activities in the area of advanced therapies.

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30.03.20

Coronavirus: FDA's Advice for the Donation of Cells, Tissue and Products Based on Them

By providing information on the safety of cell and tissue products in relation to coronavirus, the FDA gives support in questions of transferability by donors.

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30.03.20

Serological Tests for HTLV Viruses by Blood and Blood Components

Testing for virus contamination plays an important role in blood and blood components. Recently, the FDA has published a guidance document on testing for T-lymphotropic viruses by means of serological testing.

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30.03.20

Updated Recommendations for Reducing the Risk of CJD and vCJD by Blood and Blood Components

The FDA has revised its assessments and recommendations to reduce the possible risk of transmission of Creuzfeldt-Jakob by blood and blood products.

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26.03.20

European Pharmacopoeia: New Chapter on Visual Inspection for Visible Particles Comes Into Force

The new chapter 5.17.2 in the European Pharmacopoeia "Recommendations on testing of particulate contamination: visible particles" was already published for comment in autumn 2018 (Pharmeuropa 30.4). The comments and feedback received have been considered by the Expert Group 12 of the EDQM, and the chapter is coming into force.

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20.02.20

Annex 1: European Commission Publishes Revised Document

On 20 February, the European Commission published the long-awaited revision of Annex 1 Sterile Manufacturing of the EU GMP Guideline. The document is now entering a timely limited commentary phase.

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18.02.20

FDA publishes Questions and Answers on Pathogen Reduction in Blood Components

With their new questions and answers paper, the FDA wants to provide further information on the implementation of pathogen reduction techniques for blood establishments.

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18.02.20

Endotoxin and Pyrogen Testing - Challenges for Biotechnological and Biopharmaceutical Products

The introduction of alternative methods as, e.g., the Monocyte Activation Test, is a challenge for many laboratories.

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18.02.20

EMA/CHMP publishes new Q&A Document on Comparability Considerations for ATMPs

A document on the topic of comparability in the context of Changes and Variations at ATMP, published in December by the EMA, respectively the CAT, completes the series of guidelines and assistance around ATMP.

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