14 February 2018 - - Hong Kong-based integrated healthcare enterprise Golden Meditech Holdings Ltd. (SEHK:00801) associate, Houston, Texas-based T-regulatory (Treg) cellular therapies developer Cellenkos, Inc., has successfully registered its's stand-alone, manufacturing facility as good manufacturing practice (GMP) compliant with the US Food and Drug Administration (FDA), the company said.
Cellenkos is a clinical-stage biotechnology company focused on developing universal donor cell therapeutics derived from cord blood for the treatment of autoimmune diseases and inflammatory conditions.
Cellenkos manufacturing facility (CMF) manufactures cord blood-derived Treg therapeutics. CMF covers 2,000 square feet and includes a Class 10,000 (corresponding to International Organization for Standardization 7) cleanroom with gown-in/gown-out anteroom where all major equipment will remain under continuous monitoring with off-site data backup.
All preclinical research and development, as well as clinical manufacturing and packaging of clinical product will take place at CMF.
It is anticipated that CMF will have the capacity to supply sufficient quantities of Cellenkos' lead cellular therapy candidate, CK0801, for all company-sponsored clinical trials.
Cellenkos is an early stage biotechnology company that focuses on Treg cellular therapies derived from cord blood for the treatment of autoimmune diseases and inflammatory disorders. Cellenkos' lead product, CK0801, is a first-in-class, cell therapy product that overcomes immune dysfunction by inhibiting key regulators of inflammation.
Golden Meditech is an integrated-healthcare enterprise that has established dominant positions in several markets, including the medical devices market and the hospital management market in the healthcare industry.