The mar­ket­place for gene and cell man­u­fac­tur­ing ther­a­peu­tics con­tin­ues to be scorch­ing.

Cog­nate Bio­Sciences, a lead­ing CD­MO spe­cial­iz­ing in gene and cell ther­a­py tech­nolo­gies, an­nounced plans Fri­day that will dou­ble its to­tal man­u­fac­tur­ing ca­pac­i­ties at sites in both the US and Eu­rope — in di­rect re­sponse to a “great de­mand of com­mer­cial ca­pac­i­ty with­in the bi­o­log­ics in­dus­try.”

The com­pa­ny pro­vid­ed most de­tails for its US ex­pan­sion, which will take place at its cur­rent head­quar­ters in Mem­phis, Ten­nessee near the Mem­phis In­ter­na­tion­al Air­port — cru­cial, it said, as Mem­phis is one of the world’s busiest car­go air­ports. Cog­nate will add two sep­a­rate fa­cil­i­ties to­tal­ing 250,000-square-feet: a GMP dis­tri­b­u­tion cen­ter to man­age glob­al sup­ply chain needs, and a third site for com­mer­cial man­u­fac­tur­ing.

J. Kel­ly Gan­jei

“Our ex­pan­sion plans in cell and gene ther­a­py, in the US and Eu­rope, and the close prox­im­i­ty to a glob­al ship­ping and lo­gis­tics hubs, pro­vide Cog­nate BioSer­vices, to­geth­er with Co­bra Bi­o­log­ics, a unique com­pet­i­tive ad­van­tage not avail­able to oth­er CD­MOs,” Cog­nate’s CEO J. Kel­ly Gan­jei said in a state­ment. “This is crit­i­cal­ly im­por­tant to our clients around the world who are com­mer­cial­iz­ing cell and gene ther­a­pies that re­quire rapid turn around and of­ten uti­lize re­al-time ship­ping and han­dling.”

The biotech is com­mit­ted, Gan­jei said, to “rapid­ly ex­pand­ing” its glob­al reach and ca­pac­i­ty for de­vel­op­ing cell and gene ther­a­pies. Fri­day’s an­nounced ex­pan­sion is part of a 15-year Ex­pan­sion PI­LOT (pay­ment-in-lieu-of-tax­es) ap­proval from the eco­nom­ic coun­cil in Mem­phis and Shel­by coun­ties, con­tin­u­ing a three-year in­vest­ment in Ten­nessee of some $200 mil­lion by var­i­ous health­care and life sci­ence com­pa­nies.

Co­bra Bi­o­log­ics, Cog­nate’s gene ther­a­py arm that it bought last Jan­u­ary, is al­ter­ing its plas­mid DNA ser­vices for vi­ral vec­tors through a four-fold in­crease in HQ DNA man­u­fac­tur­ing ca­pac­i­ty and new clin­i­cal and cGMP fa­cil­i­ties in Eu­rope. The HQ man­u­fac­tur­ing will pro­vide a six-week de­liv­ery time for clin­i­cal­ly man­u­fac­tur­ing im­muno-on­col­o­gy ther­a­pies, Cog­nate said.

The outsourcing market for cell and gene therapies has stayed red-hot in recent months as some of the biggest CDMOs — and even major drugmakers — are diving in. Now, a Swiss CDMO wants a bigger piece of the action, and it’s looking to set up shop in Novartis’ fledgling life sciences hub in Stein.

Celonic plans to build a 91,500-square-foot manufacturing center focused on cell and gene therapies, next-gen vaccines and other “innovative” drugs as part of a two-part expansion at Novartis’ Rhine Valley hub, the CDMO said last week.

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.