News from Valicare

Laptop, coffee cup and project papers

ZellTherQC-Workshop at EBM in Lübeck, 19th of March 2019.

On the 19.03.2019, a workshop of the joint project ZellTherQC on "Quality control of cell-based therapies" will take place at the Fraunhofer EMB in Lübeck. Cell-based therapeutics, which belong to the group of so-called drugs for advanced therapy medicinal products (ATMP), represent a new and very promising method for the treatment of cancer and other serious diseases. To ensure safe and effective treatment of patients, the cell therapeutics must meet high quality standards. Therefore, quality control during the manufacturing and application process plays a central role. Since no general standard procedures for ATMPs have been established so far, ZelltherQC has set itself the task of developing an adaptable, modular strategy for the quality assurance of therapeutic cells and tissue engineered products for the improved quality control of human cells (www.ZelltherQC ).

ZellTherQC, is a network of 4 small and medium-sized companies (CLS Cell Lines Service GmbH, IBA GmbH, Ibidi GmbH, Labor Dr. Heidrich und Kollegen GmbH) and 4 research institutes (Fraunhofer Institute for Marine Biotechnology and Cell Technology (EMB), Fraunhofer Institute for Manufacturing Engineering and Automation (IPA), Fraunhofer Institute for Silicon Technology (ISIT), Innovent e.V. Technologieentwicklung Jena) coordinated by the EurA AG.

ZellTherQC organizes the workshop to exchange experiences and discuss regulatory and application-specific questions regarding the QC of ATMPs with members, speakers and experts following the aim of developing an adaptable, modular strategy for the QC of cell-based therapies.

Dr. Claudia Papewalis and Dr. Hans-Georg Eckert, Senior GMP Consultants at Valicare GmbH, will give a lecture on the topic of "Regulatory aspects regarding QC of ATMPs”. They will answer further questions and advise the discussion and roundtables of the workshop afterwards.


Further information

Dr Claudia Papewalis is giving a GMP for ATMP training


If you want to know more about the regulatory requirements requested for manufacturing ATMPs, contact our experts or take part at one of our internal GMP training courses.

A scientist is looking at t-cells visible at a computer screen

GMP-compliant manufacturing process

Valicare supports start-ups like polybiocept in transferring cell-culturing methods developed at the laboratory into a GMP-compliant manufacturing process. Check the press release and get an overview about our GMP for ATMP services.

cell culture, ATMPs

„Guidelines on Good Manufacturing Practice (GMP) specific to Advanced Therapy Medicinal Products”

On 22th of November 2017 the European Commission adopted the "Guidelines on Good Manufacturing Practices (GMP) specific to Advanced Therapy Medicinal Products".