In 2008 Agenolab GmbH & Co. KG acquired the technology to produce autologous skin transplants (KeraSeed®). This product can be used for the treatment of burn victums (plastic surgery) or for treating patients suffering from chronic wounds. Data of a multicenter clinical trial (Phase IIb/III) have been published in 2007.
In addition, Agenolab GmbH & Co. KG has access to the technology to produce autologous melanocytes for the treatment of Vitiligo patients.
Both products are regulated according to the Advanced Therapy Medicinal Product Regulation (1394/2007/EU). To treat patients the requirements outlined in the German Drug law, the German Tissue law have to be fulfilled.
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• GMP compliant production of autologous keratinocytes and melanocytes
• GMP compliant production of cell culture medium
• Sterility testing according to Ph. Eur.