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.

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.