Manufacturing

The manufacturing of Xeno cellular products requires a closed colony of animals (generally sheep) for its cell sources. The facilities are built in accordance with AAALAC (American Association for Accreditation of Laboratory Animal Care) regulations. It takes a minimum of three years before an animal colony can be designated "closed." The European method for manufacturing progenitor transplants incorporates all pertinent requirements of:

  • PHS Guidelines on Infectious Disease Issues in Xenotransplantation, January 19, 2001, (Federal Register, Volume 66, pages 8120-1) which is the official version of the same regulation issued initially as a 'Draft' on September 23, 1996 (available from Federal Register under 61FR49920).
  • Decision of the German Supreme Court in case of one BvR420/97.
  • EC Directive 2001/83/EC.
  • National laws of the European Union.
  • A manufacturing laboratory must be set-up, equipped and staffed in compliance with the laws of its respective host country, and if no applicable laws and regulations exist, then Directives of the European Union Council, U.S. FDA regulations, or WHO advisories, and GMP (Good Manufacturing Practice) rules should apply. All Progenacell laboratories are inspected on a regular basis.

Preparing progenitor stem cell transplants is a "biological" process not a "biotechnological" process. "Biological process" means manufacturing of live cells for various purposes, including cell transplantation. Biological products cannot be standardized, for it is impossible to attain uniformity and consistency of stem cell transplants from one batch to the other. The primary goals of the European manufacturing method are to abolish immunogenicity of stem cell transplants, or minimize them as much as possible, and simultaneously prevent transmission of zoonoses through treatment of Progenitor stem cell transplants. A key portion of the European method of manufacturing stem cell transplants is a unique procedure of primary tissue culture that is identical for both stem cell xenotransplants and allotransplant.

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