29 Results found
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 ...
04/15/2021
Toxicological assessment gain acceptance for cleaning validation
WHO publishes decision on setting acceptance criteria for cleaning validation
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?
01/08/2021
Integrated Qualification and Validation Guide
New ECA guide helps saving time and money by customer-supplier partnership on qualification and validation.
10/26/2020
Nitrosamines in active substances and finished medicinal products
EMA strongly requests the risk-based proof that active substances and finished medicinal products are free of nitrosamines. Are you prepared for this?
10/23/2020
Valicare Extends GxP Expertise
New Consulting Services for the Transition from Development to Clinical Manufacturing
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 ...
07/22/2020
Use public funding for consulting services!
We’re in! Valicare is now an official BAFA-consultant and can tell you how consulting costs for small and medium-sized companies can be reduced.
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