GMP News - Blood / Biologics and ATMP

04.03.21

EMA Guidance on Adjusting Vaccines to COVID-19 Variants

Authorisation requirements for adjusted COVID-19 vaccines: the EMA publishes recommendations for vaccine developers and manufacturers.

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04.03.21

FDA's Strategies for Bacterial Safety of Platelets

In December, the FDA updated its guidance on bacterial safety strategies for platelets and platelet preparations, particularly in light of the current implementation difficulties faced by facilities under pandemic conditions.

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24.02.21

Inspection of biotechnological Manufacturers - PIC/S AiM Updated

In January, the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-Operation Scheme (PIC/S) published a revised version of its Aide Memoire "Inspections of Biotechnology Manufacturers".

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23.02.21

25 Years Alternative Pyrogen Testing: Where do we stand? A Retrospect and Outlook

The EU demands to reduce animal testing or to avoid it altogether wherever possible. The pyrogen test on rabbits is therefore being replaced by MAT as an alternative in the EU. But how long has this taken and where is the journey going for alternative test systems in microbiology? A short review and outlook can be found here.

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04.02.21

CAT - Monthly Report on ATMPs

A regular insight and overview of the activities around ATMP in Europe is provided by the reports on the CAT meetings, which list the latest news on classification, authorisation and much more.

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04.02.21

FDA - Testing of Cells and Tissues Donors for Transferable Diseases

As a complement to the many guidances and documents on the development and manufacture of products from human cells and tissues, the FDA also provides an overview of strategies and approved tests for microbiological testing of donors of cells and tissues.

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04.02.21

Modern Vaccines and Platform Technologies - Explained in an Understandable Way

Questions reaching us on the subject of COVID-19 vaccines, their development, approval and production, and on modern platform technologies used are answered in a summary.

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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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