21.01.2016

DIN-Workshop: Challenges to standardization: Test procedures of cell-based products for therapy

On January 20, scientific and industry experts discussed new standards for testing and approval of cell based products.

Location: RCBE in Regensburg

Topics:

- Establishing and validating test procedures within the biological safety evaluation of medicinal products
- Validation of biological tests: Lessons learnt during an ECVAM project
- Impact of automation for the quality of cell-based products, and the resulting requirements
- Raw materials quality requirements for manufacturing cell-based products: medical grade, pharmaceutical grade, GMP: what are the industry needs?
- Test kits for cell Quality Assurance: HALO® PCA and MSCGlo-Research
- MACSQuant® Tyto: A novel method for cell sorting under sterile conditions
- The current DIN standardisation project


Further information: http://rcbe.de/en/din-workshop/