News
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
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).
FDA has approved a new therapy for HR positive breast cancer and announces plan to hold advisory meeting for Abecma in earlier treatment of ...
Image/Anastasiia Slynko ...
Coinhibitory receptors, such as CTLA-4 and PD-1, play a critical role in maintaining immune homeostasis by dampening T cell responses. ...
Catch up on the latest news, breakthroughs, and announcements from biotechnology companies making advancements in cell and gene therapies.
Preclinical study explains the previously observed anti-cancer effect of the common anesthetic drug ...
Zielgenaue Immunsuppression ...
T cells play a crucial role in the immune system’s ability to combat cancer. However, tumors are capable of turning off these T cells, ...
... https://doi.org/10.1016/j.cophys.2023.100718 ...
Researchers at the National Institutes of Health have developed a way to potentially increase the effectiveness of T cell-based ...
Review top news and interview highlights from the week ending November 17, 2023.
... https://doi.org/10.1016/j.jcyt.2023.08.011 ...
Großbritannien hat die erste Crispr-Gentherapie zugelassen – ein Meilenstein, sagt Genforscher Toni Cathomen. Bald könne ...
The development of cell therapies targeting diseases of the eye is flourishing, says Matthew Giegengack, MD ...
The future of biopharmaceutical production is shifting from centralized manufacturing to a decentralized model, bringing production closer ...
PHILADELPHIA –Gene therapy adeno-associated viruses (AAVs)—viruses that can be engineered to deliver DNA to target cells—are unlikely to ...
Dr. Ellen Sons-Brinkmann
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Mail.: ellen.sons-brinkmann@valicare.com