Cellenkos, a clinical-stage biotechnology company focused on developing universal donor cell therapeutics derived from cord blood (CB) for the treatment of autoimmune diseases and inflammatory conditions, has completed the registration of its stand-alone, manufacturing facility as Good Manufacturing Practice (GMP) compliant with U.S. FDA.

Cellenkos’ manufacturing facility makes cord blood-derived Regulatory T cell (Treg) therapeutics. Located in Houston, TX the facility covers 2,000 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 (QC) and process development laboratories with dedicated areas for storage for all raw materials and liquid nitrogen.

“FDA registration of our manufacturing facility is an important milestone as we prepare to enter company-sponsored clinical trials,” said Simrit Parmar, chief medical officer, Cellenkos. “Control over the manufacturing processes in our own facility will ensure that we are able to comply with cGMP requirements for biologics, drugs and pharmaceuticals as set out in the Code of Federal Regulations Title 21 (21CFR) and confirm that all manufacturing is accomplished with the highest level of safety, competence and proficiency as expected by the FDA and our clinical investigators.” 

All preclinical research and development, as well as clinical manufacturing and packaging of clinical product will take place at the facility. It is anticipated that it 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.