At the end of the last millennium, a new form of medicine was introduced that today, some 30 years later, likely appears to be fulfilling the promises made at that time. ATMP, “Advanced Therapy Medicinal Products“, delineate novel forms of therapy1. These products are personalized in most forms of application and are manufactured individually for each single patient, mostly starting from their own cells.
Immunotherapies are a very special highlight in this context. They promise a dramatic improvement in the clinical course of cancer treatment. For the first time, such a drug has now been approved by the FDA. The so-called CAR-T cell therapy (Novartis) combats an acute lymphatic leukemia in children². Preliminary studies showed a response rate of over 80 percent and may promise lifelong cure. The mechanism of action that is applied here can be transferred to other tumor diseases.
Although these products are highly sophisticated, common regulatory requirements apply. In consequence, these drugs are to be produced in a legally binding manner in compliance with GMP guidelines. Often they are sterile products and have to be manufactured in a clean environment. Therefore, transfer of a laboratory process to drug production is often the bottleneck, which extends the introduction of therapy by years or even prevents it.
As a wholly owned subsidiary of Bosch Packaging Technology, Valicare GmbH is specialized in making complex processes GMP compliant. Based on its many years of experience in the ATMP area, Valicare supports its customers with consulting, documentation, qualification and validation on the way to obtaining a manufacturing authorization, approval in accordance with §4b AMG and, if necessary, a subsequent central marketing authorization by the European Medical Agency. For interested people and collaborators we also offer training courses on GMP for ATMP³.
- European Medicines Agency Website
- Novartis Website
- Registration for training courses on GMP for ATMP
Claudia Papewalis, PhD
+49 69 7909-396