30 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.
03/14/2025
Efficient QMS according to EN ISO 13485: Innovation despite MDR and shortage of skilled workers
MDR and a shortage of skilled workers are challenging companies - but an efficient quality management system (QMS) creates opportunities for ...
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 ...
05/06/2024
Do your methods comply with the new ICH requirements?
ICH Q2(R2) and ICH Q14 describe mandatory requirements for the development, life cycle and validation of analytical methods.
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 ...
08/22/2023
Prohibition of PFAS – Evaluate, assess risks, time to act
Valicare experts present solutions to you Per- und Polyfluoroalkyl substances (PFAS) are widely used in the pharmaceutical and biotech industry as ...
08/02/2023
Revision of Annex 1 - New approaches are required soon!
Get an overview about the most important upcoming changes The revision of Annex 1 of the EU GMP Guideline will be effective this year. It faces ...
04/13/2023
SMEPAC Test to Measure the Tightness of Containment Systems
Working with highly active and hazardous drugs and ingredients requires evidence that the used containment systems are leak proof!
08/29/2022
Computerized System Validation (CSV) – GAMP 5 Second Edition
2nd Edition of the GAMP 5 Guideline will address required changes in computerized system validation (CSV). Have you adopted the changes yet?
07/25/2022
Celebrating 20 years of Valicare
From drug development to marketing authorization, Valicare supports chemical, pharmaceuticals and biotechnology companies around the globe.
06/25/2022
New ICH Q14 Guideline: Analytical procedure development
Analytical procedure development: harmonization, development process as well as improvement of change management, approval and communication with ...
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