Bobby Sheng, Bora Pharmaceuticals CEO

Taipei's Bo­ra wants in on the CD­MO game as re­port shows plen­ty of room for in­dus­try growth

Taipei’s Bo­ra Phar­ma­ceu­ti­cals has linked up with Taishin Health­care to in­vest about $108 mil­lion in­to CD­MOs and CROs in re­sponse to a boom­ing busi­ness en­vi­ron­ment for both in­dus­tries.

The two com­pa­nies plan to en­ter the macro­mol­e­c­u­lar, and cell and gene ther­a­py man­u­fac­tur­ing spaces, and strength­en com­pet­i­tive­ness while bol­ster­ing Tai­wan’s CD­MO mar­ket. Ac­cord­ing to a re­port from Hart­ford, CT-based re­search group Glob­al In­for­ma­tion, the glob­al CD­MO mar­ket was val­ued at $160.1 bil­lion in 2020 and could grow to as much as $242.64 bil­lion by 2026. There are five CD­MOs in the world that have rev­enue above $500 mil­lion, while 75% of the field takes in less than $50 mil­lion in rev­enue, the re­port says.

“In ad­di­tion to in­dus­try gi­ants that in­clude Lon­za, Catal­ent, WuXi Ad­vanced Ther­a­pies, Mi­naris Re­gen­er­a­tive Med­i­cine, and oth­ers, there are spe­cial­ty CD­MOs serv­ing the cell and gene ther­a­py mar­ket­place,” the re­port says. “For ex­am­ple, Fu­ji­film Cel­lu­lar Dy­nam­ics opened a $21M cGMP pro­duc­tion fa­cil­i­ty to sup­port its in­ter­nal cell ther­a­peu­tics pipeline, as well as serve as a CD­MO for iPS cell prod­ucts.”

As a re­sult, CEO Bob­by Sheng and his team at Bo­ra will lean in­to M&A to quick­ly scale up ca­pac­i­ty. The com­pa­ny has com­plet­ed three deals in the past 10 years, and plans to sup­port com­pa­nies with promis­ing port­fo­lios. The re­port from GII points to “enor­mous” M&A deals with­in the cell and gene ther­a­py sec­tor, such as Ther­mo Fish­er Sci­en­tif­ic’s ac­qui­si­tion of Bram­mer Bio for $1.7 bil­lion, and Catal­ent’s grab of Paragon Bioser­vices for $1.2 bil­lion and MaS­Ther­Cell for $315 mil­lion.

“In or­der to ef­fec­tive­ly al­lo­cate re­sources, in­ter­na­tion­al phar­ma­ceu­ti­cal mak­ers have moved to­wards spe­cial­iza­tion over the past few years, re­sult­ing in CD­MO ser­vices be­com­ing a trend sweep­ing the glob­al biotech phar­ma­ceu­ti­cal sec­tor,” Sheng said in a state­ment.

Ed­i­tor’s Note: For more news and ex­clu­sive cov­er­age from the man­u­fac­tur­ing beat, sub­scribe to the End­points Man­u­fac­tur­ing week­ly re­port in your read­er pro­file.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; 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.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Bay­er sounds re­treat from a $670 mil­lion CAR-T pact in the wake of a pa­tient death

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

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Fu­ji­film con­tin­ues its biotech build­ing spree with new fa­cil­i­ty in Chi­na

A Japanese conglomerate is making a big play in China with the opening of a new facility, as it continues to expand.

Fujifilm Irvine Scientific has opened its new Innovation and Collaboration Center in Suzhou New District, China, an area in Jiangsu province specifically designated for technological and industrial development.

According to Fujifilm, the 12,000-square-foot site will be responsible for the company’s cell culture media optimization, analysis and design services. Cell culture media itself often requires customization of formulas and protocols to achieve the desired quantity and quality of therapeutic desired. Fujifilm Irvine Scientific is offering these services from its headquarters in California and Japan to its customers globally, as well as in China now.

Proac­tive­ly pre­vent­ing short­ages: New FDA guid­ance spells out which drugs re­quire risk man­age­ment plans

As the majority of drug shortages are still associated with manufacturing-related quality issues, the FDA on Thursday published new draft guidance spelling out how to proactively assess risks to manufacturing processes and supply chains, while understanding the market’s vulnerabilities.

While drug shortages peaked in 2011, the FDA says in its new 18-page draft guidance that the number of new drug shortages “has declined significantly since” that peak, reaching a low in 2015 and 2016, thanks in part to a new law’s enactment, known as FDASIA, which helped the agency better prevent or mitigate drug supply disruptions and shortages, and clarified cGMP requirements.

Rob Etherington, Clene CEO

Mary­land of­fers loan to Clene de­spite ALS tri­al bumps

Even after Utah-based Clene failed to hit its primary endpoints for its ALS drug last year, the state of Maryland is putting its money at least behind Clene’s manufacturing facility.

The Maryland Board of Public Works has finalized a $3 million, 60-month loan facility with Clene Nanomedicine. The loan was provided by the state’s Neighborhood BusinessWorks program within the Maryland Department of Housing and Community Development.

Armon Sharei, SQZ founder and CEO

SQZ's out­side-the-box man­u­fac­tur­ing method slash­es pro­duc­tion time in ear­ly in study

At ASCO 2021 in June of last year, SQZ Biotech showcased a glimpse of its unorthodox cell therapy manufacturing tech. And on Wednesday, the Watertown, MA, company announced that its first-generation system showed comparable or better performance than a conventional clean-room-based manufacturing process.

The study was non-clinical. Clinical trials are expected by the first half of 2023.

SQZ’s device opens up a temporary window by cell-squeezing to deliver cargoes into cells. Its average processing time was less than six hours per batch, which is more than half the time than conventional methods. The company is planning to use the technology in its first red blood cell derived program for celiac disease. That IND is set to be submitted in the first half of 2023, the company said.

Bobby Sheng, Bora Pharmaceuticals CEO

With new ac­qui­si­tion, Bo­ra to ven­ture in­to bi­o­log­ics

Last week, Taiwan-based CDMO Bora Pharmaceuticals announced that it acquired Eden Biologics. Now, it says that purchase has helped established Bora Biologics, expanding into the biopharmaceutical market.

The acquisition of the company’s assets, which are located in the Hsinchu Biomedical Science Park in Taiwan, is helping Bora build its presence in the biopharma world by expanding production capacity of cell lines for the production of protein drugs. It will also improve the quality control and inspection specifications, as well as cell bank generation. The facility has four 500-liter bioreactors that have been approved by European and Taiwanese regulators.

Paul Chaplin, Bavarian Nordic president and CEO

With mon­key­pox cas­es ris­ing, one Eu­ro­pean coun­try is lock­ing down a small­pox vac­cine con­tract

As the global number of confirmed and suspected monkeypox cases continues to slowly climb, one country is trying to get a head start on potential vaccine stocking.

Bavarian Nordic signed a contract with an undisclosed European nation to supply its smallpox vaccine in response to new cases this month, the company announced Thursday morning. The continent saw its first monkeypox case confirmed about two weeks ago, with both the UK and Portugal seeing cases, according to the Washington Post.

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