While it is not un­com­mon for a biotech to go down the route of hav­ing the prod­uct man­u­fac­tured by a con­tract or­ga­ni­za­tion, one small biotech is look­ing to keep its card close to its chest.

Vor Bio­phar­ma has start­ed man­u­fac­tur­ing op­er­a­tions at an in-house fa­cil­i­ty at its HQ in Cam­bridge, MA af­ter be­gin­ning con­struc­tion last sum­mer.

Ac­cord­ing to the biotech, the fa­cil­i­ty aims to de­vel­op Vor’s hematopoi­et­ic stem cells (eHSCs) and CAR-T ther­a­pies for pa­tients with blood can­cers. The site will ini­tial­ly man­u­fac­ture a clin­i­cal sup­ply of its can­di­date VCAR33^al­lo to sup­port its IND, which is slat­ed to be sub­mit­ted in the first half of next year. It al­so plans to trans­fer the pro­duc­tion of VOR33 to the fa­cil­i­ty. Vor is get­ting to work quick­ly as en­gi­neer­ing runs for VCAR33^al­lo has start­ed this week.

Michael Pin­aud

In an email to End­points News, Michael Pin­aud, the head of GMP op­er­a­tions for Vor said that the fa­cil­i­ty is around 9,000 square feet. Due to the type of man­u­fac­tur­ing that the com­pa­ny is un­der­tak­ing, it can man­u­fac­ture its eHSCs with a small foot­print. Vor did not dis­close the fi­nan­cial fig­ures of the fa­cil­i­ty, but the site did not use any gov­ern­men­tal funds.

“We be­lieve that the up­front in­vest­ment is well worth the long-term ad­van­tages of hav­ing full con­trol over our man­u­fac­tur­ing ca­pac­i­ty, time­lines and costs,” Pin­aud said in the email to End­points.

The site is made up of four clean rooms along with two qual­i­ty con­trol lab­o­ra­to­ries, six an­a­lyt­i­cal lab­o­ra­to­ries and ware­hous­ing space. It is look­ing to scale up quick­ly as Pin­aud said the site is look­ing to hire in the ar­eas of qual­i­ty, man­u­fac­tur­ing op­er­a­tions and process de­vel­op­ment over the next few years. How­ev­er, no de­tails were giv­en on the num­ber of em­ploy­ees the com­pa­ny plans to add.

As to why the com­pa­ny is not con­tract­ing out its man­u­fac­tur­ing work, Pin­aud stressed that it al­lows Vor to main­tain full con­trol over its prod­uct.

“In­te­grat­ing in­ter­nal re­search, process de­vel­op­ment, an­a­lyt­i­cal de­vel­op­ment, man­u­fac­tur­ing and qual­i­ty con­trol test­ing ca­pa­bil­i­ties un­der one roof en­ables us to pro­vide ef­fi­cient trans­fer of knowl­edge and main­tain strate­gic con­trol of man­u­fac­tur­ing ca­pac­i­ty, and re­duce the time and cost re­quired to man­u­fac­ture com­plex cell ther­a­py clin­i­cal can­di­dates,” Pin­aud said in a state­ment.

Pin­aud al­so told End­points that the fa­cil­i­ty can sup­port all its pro­grams in its pipeline, but that Vor would even­tu­al­ly need to eval­u­ate ad­di­tion­al space to sup­port fu­ture com­mer­cial sup­ply.

When the site was an­nounced last year, then CTO Sadik Kas­sim told End­points in an in­ter­view that out­sourc­ing could give away trade se­crets, among oth­er rea­sons for bring­ing things un­der one roof.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.

A handful of CDMOs have made changes at the top over the past few weeks, including Genezen and Curia.

That also includes Australian CDMO BioCina, which announced last week that Mark Womack would be taking the helm. Womack previously served as chief business officer at AGC Biologics, CEO of Indian manufacturer Stelis Biopharma and most recently, CEO at CDMO KBI Biopharma and Selexis SA.

BioCina completed the takeover of a Pfizer manufacturing facility in Adelaide in 2021 and is now prepping for wider growth. Endpoints News sat down with Womack to discuss his new role, plans for the future, and how to compete in the wider CDMO market. This interview has been edited for brevity and clarity.