Manufacturing roundup: Terumo BCT partners with BioBridge subsidiary to manufacture cell and gene therapies; WuXi STA opens plant for HPAPI production - Endpoints News

As the man­u­fac­tur­ing of cell and gene ther­a­pies is ramp­ing up and com­pa­nies are start­ing to in­vest in their man­u­fac­tur­ing ca­pa­bil­i­ties, Teru­mo Blood and Cell Tech­nolo­gies have formed a part­ner­ship to stay in the game.

Ac­cord­ing to the com­pa­ny, it has signed a new col­lab­o­ra­tive agree­ment with Gen­Cure, a sub­sidiary of Bio­Bridge Glob­al, to ex­tend and uni­fy cell and gene ther­a­py man­u­fac­tur­ing so­lu­tions.

Both par­ties have signed the new agree­ment to fur­ther com­bine tech­nolo­gies and ex­per­tise to cater to the de­mand across the cell and gene ther­a­py in­dus­try for smart sys­tems that are au­to­mat­ed and closed.

This col­lab­o­ra­tion will look to lean on the ex­per­tise of Teru­mo and Gen­Cure to es­tab­lish a ref­er­ence man­u­fac­tur­ing cen­ter for Bio­Bridge Glob­al. This in­cludes both or­ga­ni­za­tions de­vel­op­ing core process and man­u­fac­tur­ing op­er­a­tions, with its base at Gen­Cure’s process de­vel­op­ment and cGMP man­u­fac­tur­ing fa­cil­i­ty in San An­to­nio.

The col­lab­o­ra­tion is sched­uled to last three years and oc­cur in two phas­es. The first phase will en­able Teru­mo to se­lect from its port­fo­lio of gene ther­a­py man­u­fac­tur­ing de­vices and share the range of ser­vices of­fered at Gen­Cure. This com­bi­na­tion is aimed to help solve in­dus­try gaps in man­u­fac­tur­ing ca­pac­i­ty and op­er­a­tional ex­per­tise.

The sec­ond phase will al­low Gen­Cure and oth­er Bio­Bridge Glob­al sub­sidiaries to use Teru­mo’s da­ta man­age­ment and val­ue-added ser­vices to tran­si­tion be­tween clin­i­cal and man­u­fac­tur­ing sites by en­abling chain-of-cus­tody/iden­ti­ty and con­sis­ten­cy of leuka­phere­sis prod­ucts.

“De­spite the rapid evo­lu­tion of the cell and gene ther­a­py sec­tor, crit­i­cal chal­lenges such as man­age­ment be­tween the col­lec­tion, man­u­fac­tur­ing sites and lo­gis­tics still re­main un­re­solved. For over 20 years. Teru­mo has been work­ing with Bio­Bridge to pro­vide safe, high-qual­i­ty blood prod­ucts. We are now com­bin­ing our prod­uct port­fo­lios, ex­per­tise and man­age­ment to pro­vide a vi­tal link be­tween cell col­lec­tion sites and cell and gene ther­a­py man­u­fac­tur­ing sites while ad­dress­ing ca­pac­i­ty and en­sur­ing GMP pro­duc­tion,” said De­lara Mot­lagh, gen­er­al man­ag­er of cell ther­a­py tech­nolo­gies at Teru­mo.

WuXi STA opens high-po­ten­cy API plant in Jiang­su, Chi­na

WuXi STA has been on a roll over the past year, ex­pand­ing its op­er­a­tions in Eu­rope and the US, but it is turn­ing to Chi­na for its next open­ing.

Ac­cord­ing to the com­pa­ny, it has opened an­oth­er high-po­ten­cy API(HPA­PI) plant at its Changzhou site lo­cat­ed in Jiang­su, Chi­na. The new plant is de­signed to meet the grow­ing de­mand for high-po­ten­cy APIs.

While the com­pa­ny did not dis­close the fi­nan­cial de­tails or em­ploy­ee head­count of the plant to End­points News, the plant is over 12,000 square-feet and is open and now in op­er­a­tion.

The plant’s man­u­fac­tur­ing ser­vices con­sist of re­ac­tors from 250 L to 3,000 L, prep-HPLC sys­tems, a 10 m2 tray lyophiliz­er, as well as flow chem­istry and milling tech­nolo­gies.

WuXi STA’s most cur­rent plant adopts ad­vanced iso­la­tion tech­nolo­gies with the ca­pa­bil­i­ty to han­dle po­tent com­pounds with OEL as low as 10 ng/m3.

Cur­rent­ly, WuXi STA has two oth­er sites lo­cat­ed in Shang­hai and Changzhou to sup­port the de­vel­op­ment and man­u­fac­ture of HPA­PIs as well.

Last year, the CD­MO ac­quired Bris­tol My­ers Squibb’s site in Cou­vet, Switzer­land — which spe­cial­izes in com­mer­cial-scale pro­duc­tion of var­i­ous cap­sules and tablet dosage forms. The com­pa­ny al­so set­tled on New Cas­tle Coun­ty, DE, as the home for its newest CD­MO site. The com­pa­ny plans to build on 190 acres and add up to 50 lo­cal jobs by 2026.

Avid Bio­science opens a $75M plant far ear­li­er than ex­pect­ed

Af­ter quick work, Avid Bio­sciences is look­ing to ex­pand its hori­zons once again and dive head­first in­to the com­pet­i­tive cell and gene ther­a­py space.

The com­pa­ny has opened a new 53,000-square-foot vi­ral vec­tor cGMP man­u­fac­tur­ing site down the road from its Tustin, CA, head­quar­ters in Cos­ta Mesa, CA, af­ter on­ly eight months of con­struc­tion.

The site was sched­uled to open in Jan­u­ary 2023 but has sped along and will see Avid look to run in an ever-com­pet­i­tive mar­ket as the site will serve man­u­fac­tur­ing in the cell and gene ther­a­py mar­ket. At full build-out will in­clude ca­pac­i­ty for ad­her­ent and sus­pen­sion cul­tures. The sec­ond phase is ex­pect­ed to be­come op­er­a­tional in the mid-cal­en­dar year 2023. The site will al­so look to bring the com­pa­ny’s po­ten­tial rev­enue to around $350 mil­lion.

“Ex­pand­ing our of­fer­ings in­to vi­ral vec­tors was a nat­ur­al ad­ja­cen­cy for Avid, as pre­vi­ous­ly ex­plained by our CEO, Nick Green. How­ev­er, the work re­al­ly came down to find­ing a de­sign-build part­ner with the process, de­sign, and con­struc­tion ex­per­tise to help us de­liv­er a best-in-class fa­cil­i­ty with­in a con­strained sched­ule and bud­get,” said Mike Al­ston Jr., di­rec­tor of project en­gi­neer­ing for Avid Bioser­vices.

This comes on the heels of Avid in­vest­ing $6 mil­lion, ex­pand­ing its lab­o­ra­to­ries in Tustin around its ca­pac­i­ty for its mam­malian cell busi­ness. That ex­pan­sion could sup­port an ad­di­tion­al $20 mil­lion in an­nu­al process de­vel­op­ment rev­enue, dou­bling the com­pa­ny’s cur­rent process de­vel­op­ment ca­pac­i­ty.

Dutch CD­MO en­ters the com­mer­cial man­u­fac­tur­ing game

While fo­cused on R&D ca­pa­bil­i­ties and con­tracts in the past, the Dutch-based Batavia Bio­science will en­ter the full com­mer­cial man­u­fac­tur­ing game.

The com­pa­ny an­nounced that it will ex­tend its CD­MO ser­vices port­fo­lio to in­clude com­mer­cial man­u­fac­tur­ing ser­vices.

To ac­com­mo­date this shift, the com­pa­ny has fi­nal­ized the de­sign plans of its new 12,000-square-me­ter build­ing to be re­al­ized at the Bio­science Park in Lei­den, The Nether­lands. It is ex­pect­ed that the man­u­fac­tur­ing fa­cil­i­ty will be op­er­a­tional some­time in Q3 of 2024. No fi­nan­cial de­tails on the plant were dis­closed.

The mul­ti-prod­uct fa­cil­i­ty is de­signed to sup­port the late-stage clin­i­cal man­u­fac­tur­ing and com­mer­cial man­u­fac­tur­ing of vac­cines and vi­ral vec­tor-based gene ther­a­py and im­mune-on­col­o­gy prod­ucts.

Batavia’s man­u­fac­tur­ing tech­nol­o­gy, called HIP-Vax, which uti­lizes fixed-bed biore­ac­tors, will be the main plat­form. How­ev­er, the com­pa­ny will al­so uti­lize prod­ucts man­u­fac­tured us­ing tra­di­tion­al mam­malian cell sus­pen­sion tech­nolo­gies up to 1000L scale can read­i­ly be de­liv­ered.

“This is a ma­jor step for Batavia as the com­pa­ny tran­si­tions from a CD­MO that could as­sist its clients in R&D and clin­ic man­u­fac­tur­ing on­ly, to now, a ‘one-stop-shop’ where it will be able to sup­port clients from con­cept prod­uct idea all the way to full mar­ket launch and com­mer­cial man­u­fac­tur­ing,” said Men­zo Haven­ga, Batavia CEO.

Bio­man­u­fac­tur­ing cam­pus com­ing to the edge of the Bay Area.

The Bay Area is get­ting an­oth­er lift in the man­u­fac­tur­ing field.

Com­mer­cial re­al es­tate com­pa­ny, Tran­swest­ern Ven­tures (TWV) and the city of Va­cav­ille, CA, will de­vel­op a 390,000-square-foot bio­man­u­fac­tur­ing cam­pus on 22.4 acres in Va­ca Val­ley Busi­ness Park, lo­cat­ed at the in­ter­change of I-80 and I-505.

Ac­cord­ing to Tran­swest­ern, the project will be built in two phas­es, with the first phase com­pris­ing 233,888 square-feet with de­liv­ery es­ti­mat­ed in Sum­mer 2024, with the sec­ond com­pris­ing 158,316 square-feet.

Va­cav­ille is sit­u­at­ed along the main thor­ough­fare be­tween Sacra­men­to and the rest of the Bay Area. Com­pa­nies such as Agenus, Kaiser Per­ma­nente, Genen­tech and Po­laris al­so have a pres­ence in Va­ca Val­ley Busi­ness Park. The site new­ly ac­quired by TWV was sourced by Tran­swest­ern Re­al Es­tate Ser­vices and pur­chased in an off-mar­ket trans­ac­tion.

In an email to End­points News, Tran­swest­ern did not dis­close the fi­nan­cial de­tails but stat­ed that the man­u­fac­tur­ing at the cam­pus will ul­ti­mate­ly be de­ter­mined by user de­mand but most like­ly re­lat­ed to the life sci­ences and/or food tech­nol­o­gy in­dus­tries. The project is be­ing de­signed with max­i­mum flex­i­bil­i­ty to ac­com­mo­date a va­ri­ety of users.

Tran­swest­ern is now ac­tive­ly search­ing for ten­ants for the fa­cil­i­ty, but though no one has signed on yet, it es­ti­mates the lo­ca­tion will have around 500 em­ploy­ees at the fewest.

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