Policy & Regulation
Cellenkos Registers GMP Manufacturing Facility with FDA
12 February 2018 - - Houston, Texas-based T-regulatory (Treg) cellular therapies developer Cellenkos Inc. has successfully registered its stand-alone manufacturing facility as good manufacturing practice (GMP) compliant with the US Food and Drug Administration, the company said.
The Cellenkos manufacturing facility (CMF) manufactures cord blood-derived regulatory T cell (Treg )therapeutics. It covers 2000 square feet and includes a Class 10,000 (ISO 7) cleanroom with gown-in/gown-out anteroom where all major equipment will remain under continuous monitoring with off-site data backup.
Ancillary, non-classified space in the facility includes dedicated quality control and process development laboratories with dedicated areas for storage for all raw materials and liquid nitrogen.
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 plans to initiate Phase 1 study of CK0801 in the first half of 2018 to assess its activity, pharmacokinetics and safety in patients with a variety of autoimmune diseases and inflammatory disorders.
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.