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:
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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