The future of drug development is attributed to advanced therapy medicinal products (ATMP). And the future is already reality: an ATMP was recently approved that supplements the patient’s own T cells with a chimeric antigen receptor (CAR-T), allowing them to recognize the tumor with high efficiency and kill him.
This new drug division demands a multitude of new requirements in the development and manufacturing, since medication usually involves the administration of individual preparations. The development often starts with a laboratory process; if this has been transformed into a GMP-compliant manufacturing process, logistics and batch size (this is often 1) represent the next challenges.
Valicare supports its customers in the development of GMP processes for such products and adapts the manufacturing requirements strategically to the future market. A service, as individual as the envisaged drug.
In addition, Valicare experts offer all other industry standard compliance services, such as qualification, validation, audits and GAP analyses, but also subject-specific trainings (GMP for ATMPs, free of charge, at the Frankfurt location) and beyond that support special events, such as the “APV Interactive Workshop on ATMP: Bridging standard pharma concepts and ATMP” (in Vienna in September 2018).
- 27-28th of September 2018: Interactive workshop focused on Advanced Therapy Medical Products (ATMP)
23th of October 2018: GMP-compliant qualification, in-house training
15th of November 2018: GMP for ATMPs in-house training
Valicare, a subsidiary of Bosch Packaging Technology, with many years of experience in the ATMP sector. Please contact us directly or meet us at the announced events.
Dr. Ellen Sons-Brinkmann
+49 69 7909-350