Manufacturing for the RTC

The Clinic for Cardiac Surgery at Rostock University in cooperation with its partners is legally entitled for procurement of tissues and manufacturing of stem cell products for human use. Stem cells used at the RTC for therapy are classified as “Advanced Therapy Medicinal Products = ATMPs” and have to comply with the ATMP- regulation which became effective end of December 2008.

Manufacturing of the investigational medicinal products for the current clinical Phase III trial is carried out by the cooperation partners Seracell stem cell technology GmbH (Rostock) and Miltenyi Biotec GmbH (Teterow).

Production according to “Good Manufacturing Practise”-principles

The commercial or professional production of medicinal products – including those of human origin – requires authorisation by the corresponding authorities. §13 of the German Medicines Act describes the legal requirements for manufacturing, including the production of investigational medicinal products for clinical studies.
There are different regulations for tissue-products which are not classified as Advanced Therapy Medicinal Products. In those cases, the above mentioned authorisation is replaced by a special authorisation. More details regarding these regulations can be found under Authorisation 

To ensure the quality and safety the manufacturer of medicinal products has to comply with the international effective standards according to the rules of “Good Manufacturing Practice” (GMP). The corresponding EU-directive (Dir. 2003/94/EC) contains detailed rules and guidelines for quality management, certification, and documentation, regulates the equipment of the production facilities and the education of employees and administers issues about risk management. 

More details about GMP can be found  here.

back to top