Highlights from the GMP market and Valicare
You want to know what is driving the industry and ourselves? We have compiled the recent news for you here.
12 Results found
05/05/2025
Efficiently documenting a Contamination Control Strategy for Cell and Gene Therapy Products
Preparation of a contamination control strategy can be challenging. Join our webinar series and get help from our GMP experts.
06/05/2024
Automation and robotics for ATMPs
Robotics and automation offer groundbreaking manufacturing methods for ATMPs. ATMPs are achieving groundbreaking success in the treatment of ...
12/05/2023
The first CRISPR/Cas9-based therapy has reached the market
The admission of Casgevy (Exagamglogene autotemcel) opens a new chapter in CRISPR/Cas9-based gene therapy and ATMP manufacture
11/10/2023
Transferring novel therapies successfully to patients and market
"ATMPs" – a long way from development to clinical trial – here's how to get there safely! ATMPs (advanced therapy medicinal products) are considered ...
05/27/2021
Novelties by EMA on medicinal products with genetically modified cells
Updated EMA guideline for medicinal products containing genetically modified cells provides innovations, recommendations and improvements to be ...
02/10/2021
FDA approves Breyanzi®, a new CAR-T cell therapy drug
Fourth approved CAR-T cell therapy soon to be available in Europe?
02/04/2021
Vaccinations with mRNA-based medicinal products
How do mRNA-based medicinal products work and how safe are they?
09/24/2020
MSC & Covid-19
In order to identify approaches to manage the current Covid-19 pandemic, the therapeutic use of mesenchymal stromal cells (MSCs) is increasingly ...
08/24/2020
FDA opens up approval process for RYONCYL™
Mesoblast Ltd, headquartered in Australia with subsidiaries in the USA and Singapore, develops and distributes innovative allogenic cell therapeutics ...
08/04/2020
FDA approves CAR T-cell therapy Tecartus™
On July 24, 2020, the US health authority FDA approved Tecartus™ (formerly KTE-X19) a cell-based gene therapy based on the chimeric antigen receptor ...
01/17/2020
BioNTech SE acquires Neon Therapeutics
In mid-January the biotech company BioNTech SE based in Mainz announced the acquisition of the US-American T-cell therapy specialist Neon ...