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

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.

Vac­cine doc­u­ments, young lead­ers and mar­ket tur­moil: End­points' 10 biggest sto­ries of 2022

It’s been a volatile year in the world of biopharma. Market declines reset M&A valuations, and may be beginning to tempt bigger buyers back into dealmaking. Russia’s war in Ukraine disrupted drug sales and clinical trials. A new generation of young biotech leaders emerged in the Endpoints 20(+1) Under 40. And as capital runs dry in a tough environment for raising new funds, companies big and small are taking a look at their headcounts and operations for ways to make it through lean times.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.

That stinging early rebuke pointed straight down the path to a corrosive in-house agency review of Spectrum’s attempt to land an accelerated approval for the oral EGFR TKI and a public whipping that included a classic takedown by none other than Richard Pazdur, who slammed the company for “poor drug development” that led to confusion over the dose needed for a slice of NSCLC patients harboring HER2 exon 20 insertion mutations.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As you start planning for #JPM23, we hope you will consider joining Endpoints News for our live and virtual events. For those who are celebrating Thanksgiving, we hope you are enjoying the long weekend with loved ones. And if you’re not — we’ll see you next week!

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

FDA tells Catal­ent to fix is­sues at two man­u­fac­tur­ing sites on its own

The CDMO Catalent will have to fix issues at two manufacturing plants in the US and Europe that were subject to inspections by the FDA this summer, giving the company room to correct the issues without facing further regulatory action.

The FDA gave Catalent a “voluntary action indicated” response to two inspections at the contract manufacturer’s site in Bloomington, IN, and Brussels, Belgium. Fixing the issues on its own is a preferable outcome to facing an “official action indicated” response, meaning that an official warning would be sent out or a sit-down with the FDA would be required.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Sta­da to place $50M+ in­vest­ment in a new fa­cil­i­ty in Ro­ma­nia

While Romania may conjure up images of vast mountain ranges and tales of medieval kings, one generic manufacturer has broken ground on a new facility there.

German pharma company Stada said Monday that it has placed a €50 million ($51.9 million) investment into a 100,000 square-meter (1.08 million square-foot) site in Turda, Romania, a city in the Southeast of the country. According to a Stada spokesperson in an email to Endpoints News, the company has developed only 281,500 square feet of the site so far.

Albert Bourla, Pfizer CEO (John Thys/POOL/AFP via Getty Images)

Pfiz­er CEO un­der fire from UK watch­dog over vac­cine com­ments — re­port

Pfizer CEO Albert Bourla told the BBC last December that he had “no doubt in my mind that the benefits, completely, are in favor” of vaccinating 5- to 11-year-olds for Covid-19. Almost a year later, those comments have reportedly landed him in trouble with a UK pharma watchdog.

Children’s advocacy group UsForThem filed a complaint with the UK’s Prescription Medicines Code of Practice Authority (PMCPA) last year accusing Bourla of making “disgracefully misleading” statements during the BBC interview, including one that “Covid in schools is thriving.” At the time, UK regulators had not yet cleared the vaccine for the 5 to 11 age group, though the vaccine did have a positive opinion from the EMA’s human medicines committee.

Post-Brex­it UK trade re­port shows 'wor­ry­ing' signs for life sci­ences

The UK life sciences industry has always been a a bright spot for its American trade partners, but a new report from the UK government’s Board of Trade raises some fresh concerns about the UK life sciences in the post-Brexit environment.

The report, published Monday, showed that life science-related trade between the UK and its US and European partners declined, sometimes substantially, over the last five years. For instance, UK life sciences exports from 2016-2021 declined by 17% to Spain, -14% to Italy, -13% to Poland, and -11% to Germany.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

Merck targets vaccine-hesitant parents in its latest 'Why Vaccines' campaign. (Image: Shutterstock)

Mer­ck­'s lat­est 'Why Vac­ci­nes' cam­paign seeks to bet­ter in­form vac­cine-hes­i­tant moms

From Hollywood couple endorsements to targeted equity efforts, Merck has been pushing the value of vaccinations, especially since the Covid-19 pandemic disruption. Now the pharma is turning to a new target — vaccine-hesitant parents, and moms in particular.

Merck’s “Why Vaccines” latest social media and digital campaign spotlights real-life new moms who have questions about vaccinating their children.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

In­dus­try groups, CVS pick apart FDA's pro­posed path­way for gener­ics to carve out OTC in­di­ca­tions

Pharma industry groups like the Association for Accessible Medicines (AAM) and PhRMA are raising pointed questions about an FDA plan to create a new pathway for marketing prescription drugs with an additional condition for nonprescription use (ACNU), which would require more safeguards than the current OTC pathway but essentially carve out new OTC uses for some generic drugs.

Chief among the concerns were: Insurance companies dropping coverage for the Rx version, new ACNU patents to block competition, and industry essentially governing the pathway.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.