News
07th of May 2024: Do your methods comply with the new ICH requirements?
22th of August 2023: Prohibition of PFAS – Evaluate, assess risks, time to act
13th of April 2023: SMEPAC Test to Measure the Tightness of Containment Systems
29th of August 2022: Computerized System Validation (CSV) – GAMP 5 Second Edition
1th of June: New ICH Q14 Guideline: Analytical procedure development
18th of February: Revision of ICH Q9 (R1) Guideline on Quality Risk Management
15th of April 2021: WHO publishes decision on setting acceptance criteria for cleaning validation
8th of January 2021: Integrated Qualification and Validation Guide
2th of December 2020: Good Manufacturing Practice (GMP)
26th of October 2020: Nitrosamines in active substances and finished medicinal products
15th of June 2020: Current trends and outlook on cleanroom requirements
12th of June 2020: Pharmaceutical procurement & supplier qualification
5th of December 2023: The first CRISPR/Cas9-based therapy has reached the market
10th of November 2023: Transferring novel therapies succesfully to patients and market
4th of February 2021: Vaccinations with mRNA-based medicinal products
9th of October 2020: 2nd APV Interactive Workshop on ATMP
24th of September 2020: MSC & Covid-19
24th of August 2020: FDA opens up approval process for RYONCYL™
4th of August 2020: FDA approves CAR T-cell therapy Tecartus™
17th of January 2020: BioNTech SE acquires Neon Therapeutics
9th of January 2020: New legal regulations governing the application of ATMPs
Our international press review contains a selection of news and recent articles on advanced therapy medicinal products (ATMPs), chimeric antigen receptor T-cell therapy (CAR), tumor infiltrating lymphocytes (TILs) and bioengineered tissue products (TEPs).
On Jan 29th 2024, FDA released their Guidance for Industry on Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell ...
Cell and gene therapies still have long way to go in fulfilling promise ...
SPONSOR ...
The Environmental Monitoring Handbook is a practical guide that covers everything from the technology of particle counting, to the ...
The Cell and Gene Therapy Catapult (CGT Catapult), an independent innovation and technology organisation specialising in the advancement of ...
... 10.05.2021 13:07 Ein Drittel der für Lebensprozesse essentiellen Proteine werden in der ...
Catch up on the latest news, breakthroughs, and announcements from biotechnology companies making advancements in cell and gene therapies.
Illustration of CAR (chimeric antigen receptor) T cell immunotherapy, a process that is being developed to treat cancer. T cells (one at ...
In the journal Nature Biotechnology , scientists at Ludwig Cancer Research reported the development of an AI model to identify the most ...
Für seine Arbeit über Extrazelluläre Vesikel (EVs) und deren Anwendung bei der Behandlung entzündlicher Prozesse ...
Published: May 07, 2024 ...
Executive Summary Advances in synthetic biology are moving biopharma closer to a world where treatments can be tailored while remaining ...
SPONSOR ...
F ollowing significant progress in late 2023, the field of cell and gene therapy (CGT) has kept up its momentum into the first quarter of ...
Der effiziente und praxisnahe Einsatz von Zellkulturen in Toxizitäts- und Wirkstofftests wird ermöglicht ...
Dr. Ellen Sons-Brinkmann
Tel: +49 69 153 293 709
Mail.: ellen.sons-brinkmann@valicare.com