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.

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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.

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.

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.

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.

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.