In Ju­ly, con­tract man­u­fac­tur­er AM­RI re­brand­ed as Cu­ria, and wran­gled two biotechs to aid in its move to­ward glob­al ex­pan­sion. Thurs­day, the com­pa­ny an­nounced that it will up its com­mer­cial man­u­fac­tur­ing at its Rens­se­laer, NY site.

Cu­ria will in­vest more than $35 mil­lion to dou­ble the batch-size scal­ing and pack­ag­ing op­er­a­tions, and al­low Cu­ria to man­u­fac­ture APIs for new prod­ucts.

“Our Rens­se­laer team’s his­to­ry of ex­cel­lence in de­liv­er­ing U.S.-based com­plex man­u­fac­tur­ing so­lu­tions that en­able our cus­tomers to pro­vide vi­tal treat­ments to pa­tients is re­sult­ing in in­creas­ing de­mand,” CEO John Ratliff said in a press re­lease. “Some of the life-sav­ing prod­ucts pro­duced at Rens­se­laer are high­ly com­plex, in­clud­ing crit­i­cal on­col­o­gy ther­a­peu­tics and nov­el treat­ments ad­dress­ing un­met med­ical needs. The en­gi­neer­ing and tech­nol­o­gy ad­vances we have de­signed for the site will en­hance our flex­i­bil­i­ty, ef­fi­cien­cy and scale, al­low­ing us to meet our cus­tomers’ cur­rent and fu­ture com­plex man­u­fac­tur­ing needs.”

The ex­pan­sion will be done with­in the next 18 months, the com­pa­ny said. Cur­rent­ly, there are API man­u­fac­tur­ing sites in France, Spain, In­dia and Italy, in ad­di­tion to the US.

In bat­tle against food al­ler­gies, Al­ladapt to build site to prep for PhI­II tri­als

Al­ladapt Im­munother­a­peu­tics will build a new man­u­fac­tur­ing site to de­vel­op its lead can­di­date, fo­cused on treat­ing IgE-me­di­at­ed food al­ler­gy.

The site will be 53,000 square feet and is lo­cat­ed near Philadel­phia, where the com­pa­ny’s CMO is lo­cat­ed.

The goal is to even­tu­al­ly get full-scale pro­duc­tion ca­pac­i­ty for Phase III tri­als of ADP101. The can­di­date is de­signed to ad­dress the al­ler­gies to foods con­nect­ed with 90% of all food al­ler­gies. Right now, the drug is in Phase I/II tri­als.

“One of the great strengths of Al­ladapt is our tech­ni­cal op­er­a­tions team, which has spent years ad­dress­ing the spe­cial­ized, nov­el chal­lenges as­so­ci­at­ed with pro­duc­ing phar­ma­ceu­ti­cal-grade sin­gle-and mul­ti-al­ler­gen oral im­munother­a­peu­tic agents,” CTO Mike Holfin­ger said in a press re­lease.

Food al­ler­gies to peanuts, tree nuts, fish and shell­fish are as­so­ci­at­ed with fa­tal and near-fa­tal food-in­duced ana­phy­lax­is, and as of now, the best way to treat the al­ler­gy is avoid­ance of the foods, Al­ladapt said.

Ex­pand­ed ca­pac­i­ty com­ing to Rentschler’s Mass­a­chu­setts man­u­fac­tur­ing site

Six months af­ter an­nounc­ing the ad­di­tion of a UK cell and gene ther­a­py man­u­fac­tur­ing site, Ger­man CD­MO Rentschler Bio­phar­ma will ex­pand its Boston pro­duc­tion site in Mil­ford, MA for two new biore­ac­tors and more clean­room space.

The new clean­rooms will add 22,000 square feet of space, and two 2,000 L sin­gle-use biore­ac­tors will cut the com­plex­i­ty of man­u­fac­tur­ing, the com­pa­ny said in a re­lease. The site is ex­pect­ed to be up and run­ning by late 2023.

With the plan comes an ex­pan­sion of qual­i­ty con­trol, de­vel­op­ment and a ware­house. In a press re­lease, CEO Mar­tin Kessler said:

This is a very time­ly step, as the bio­phar­ma CD­MO mar­ket is ex­pect­ed to grow by dou­ble dig­its over the next years, and RBMC US will play a piv­otal role in our plans to con­tin­u­al­ly out­per­form the over­all mar­ket de­vel­op­ment. This new site will dou­ble our com­mer­cial cGMP man­u­fac­tur­ing ca­pac­i­ty. By bring­ing in state-of-the-art tech­nol­o­gy and in­dus­try 4.0 so­lu­tions, RBMC US will strong­ly en­hance our val­ue propo­si­tion in com­mer­cial man­u­fac­tur­ing.

So far, the Mil­ford site has ex­pand­ed from a sin­gle-prod­uct fa­cil­i­ty to one pro­duc­ing sev­er­al prod­ucts with a 500 L biore­ac­tor set­up.

To aid in mR­NA bot­tle­neck, Bio­tage opens site in UK

In an ef­fort to up its mR­NA pro­duc­tion and of­fer off-the-shelf lipids to use in vac­cine pro­duc­tion, Bio­tage will triple its pro­duc­tion ca­pac­i­ty by adding a new site in Cardiff, UK.

The move will help bat­tle the raw ma­te­r­i­al bot­tle­neck that’s been caused by the ramp-up in vac­cine pro­duc­tion that’s come from the Covid-19 pan­dem­ic. The new site is op­er­a­tional as of Mon­day.

“Our cus­tomers need­ed to man­u­fac­ture their prod­ucts on a sig­nif­i­cant­ly larg­er scale, and we were able to in­vest in an ex­pan­sion of our ex­ist­ing pro­duc­tion fa­cil­i­ties to sup­port their re­quire­ments. We were very pleased to be able to de­liv­er this ex­pan­sion in just over four months in or­der to meet the needs of present and po­ten­tial new clients,” EVP An­ders Wik­ström said in a state­ment.

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.