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).
A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal ...
Tragen aktivierte T-Zellen ein bestimmtes Markerprotein auf ihrer Oberfläche, so werden sie von natürlichen ...
ROR1-spezifische CAR-T Zellen zeigen starke Antitumor-Wirksamkeit bei fortgeschrittenem adrenokortikalen Karzinom. Für dieses ...
By BioPhorum Implementing alternative methods for adventitious agents can slash >90% of testing time and realize cost savings of up to $5 ...
Testing for the presence of neutralizing antibodies is an essential step before patients can receive Beqvez.
Author links open overlay panelLauralie Short 1 2, Robert A. Holt 1 2 3 4, Pieter R. Cullis 5, Laura Evgin 1 2 3 ...
Tumor cells are "cunning," according to Peter Yingxiao Wang. They have a nefarious way of evading the human immune responses that fight ...
Catch up on the latest news, breakthroughs, and announcements from biotechnology companies making advancements in cell and gene therapies.
... by Stephan Krause, PhD and Adam Boyer, Myers Squibb ...
Here are the latest FDA approvals, designations, and decisions from April 2024.
Emily Whitehead made the history books in 2012 when she become the first pediatric patient with B-cell acute lymphoblastic leukemia to be ...
The following is a summary of “Potential application of mesenchymal stromal cells as a new therapeutic approach in acute respiratory ...
... 28.04.2021 19:06 Für die Krebsforschung haben Ulmer Wissenschaftlerinnen und Wissenschaftler Bauchspeicheldrüsen-Organoide ...
Newswise — Coronavirus disease 2019 (COVID-19) is an acute respiratory infection caused by severe acute respiratory syndrome coronavirus 2 ...
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 ...
Dr. Ellen Sons-Brinkmann
Tel: +49 69 153 293 709
Mail.: ellen.sons-brinkmann@valicare.com