Work taking place in the clean rooms at Vor (Credit: Vor)

Vor Bio opts to keep man­u­fac­tur­ing op­er­a­tions in-house for de­vel­op­ing stem cell, CAR-T ther­a­pies

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 VCAR33al­lo 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 VCAR33al­lo 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.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

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