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
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).
The fact is that most in the biotech industry know that cell and gene therapies- CGT are regulated across the U.S. as biological products ...
Review top news and interview highlights from the week ending April 19, 2024.
University of California - San Francisco Grant of up to $11 million will fund a clinical trial at UCSF that uses a smarter new CAR-T ...
Omid Hamid, MD, gives his perspective on the use of tumor-infiltrating lymphocyte therapy for patients with melanoma.
Following an investigation that began in November 2023, the FDA now requires boxed warnings regarding T-cell malignancies on all BCMA- and ...
Molecular Code Stimulates Pioneer Cells to Build Blood Vessels in the Body ...
Members of the European Parliament (MEPs) have voted overwhelmingly in favour of the pharmaceutical reform package following a debate on 10 ...
Protein-based fibers combine unique mechanical properties with biocompatibility and biodegradability, and often outperform polymer-based ...
By Alex Santos, CMC regulatory scientist Traditionally, biopharmaceutical companies employed an in-house approach, keeping product ...
AbstractTransfected stem cells and T cells are promising in personalized cell therapy and immunotherapy against various diseases. However, ...
SARS-CoV-2 provokes devastating tissue damage by cytokine release syndrome and leads to multi-organ failure. Modeling the process of immune ...
Across the biopharmaceutical industry, many have expressed concern about the protracted timelines for drug development, which on average ...
AbstractAging skin, vulnerable to age-related defects, is poor in wound repair. Metabolic regulation in accumulated senescent cells (SnCs) ...
By Pankaj Singh, Global Market Insights Cell counting is a fundamental technique used across the life sciences, from medical testing to ...
By The ASCO Post Staff Posted: 4/3/2024 9:28:00 AM Last Updated: 4/3/2024 9:40:20 AM High levels of tumor-infiltrating lymphocytes (TILs ...
Dr. Ellen Sons-Brinkmann
Tel: +49 69 153 293 709
Mail.: ellen.sons-brinkmann@valicare.com