John Rim, Samsung Biologics CEO

Af­ter a ban­ner year, Sam­sung will charge for­ward with 'su­per plan­t' plans, and look to ex­pand abroad

Sam­sung Bi­o­log­ics’ fu­ture plans in­volve a lot of big, im­por­tant, ex­pen­sive build­ings. And now, the com­pa­ny re­vealed in its Q4 earn­ings meet­ing, sev­er­al of those ex­pen­sive build­ings, part of a mas­sive “su­per plant,” will fea­ture a heavy em­pha­sis on mR­NA, as the suc­cess and de­mand for Covid-19 vac­cines con­tin­ue to pay off.

Plant 5, the most re­cent­ly an­nounced build­ing of its $2 bil­lion “su­per plant,” will fea­ture mul­ti-modal mR­NA, pDNA and vi­ral vec­tor prod­uct ser­vices, in ad­di­tion to cell and gene ther­a­pies. That will be in ad­di­tion to a vac­cine drug sub­stance man­u­fac­tur­ing suite that’s ex­pect­ed to be ready to go at the al­ready-erect­ed fa­cil­i­ties in Song­do with­in the “ear­li­er part of this year,” Sam­sung said.

Sam­sung made waves in No­vem­ber when it un­veiled its plans for a fifth man­u­fac­tur­ing build­ing at its Song­do, In­cheon, South Ko­rea site at the end of 2021. The an­nounce­ment came fol­low­ing the ap­proval to pur­chase 32,808 square feet in the city, and the price tag for con­struc­tion will sit around $259 mil­lion.

“The mR­NA DS plant will achieve cGMP readi­ness by the sec­ond quar­ter, and we will break ground for the con­struc­tion of the mul­ti modal plant, or P5, with­in this year in or­der to ex­pand the busi­ness port­fo­lio,” CEO John Rim said through a trans­la­tor in a video re­cap­ping the JP Mor­gan Con­fer­ence ear­li­er this month.

It seems to on­ly make sense that an em­pha­sis has been placed on mR­NA, as the suc­cess of the mol­e­cule has been a large rea­son for the growth of the CD­MO in­dus­try, with Sam­sung in­clud­ed. The com­pa­ny inked a deal with Mod­er­na for fill and fin­ish ser­vices for Covid-19 vac­cines, and an­oth­er with Green­light Bio­science in De­cem­ber to pro­duce vac­cine sub­stances. The re­sult: $371.3 mil­lion in rev­enue.

In a CPhI re­port pub­lished around the time of the con­fer­ence in Italy in No­vem­ber, Sam­sung Bi­o­log­ics was named among the top five drug man­u­fac­tur­ers out there, with near­ly half of all ca­pac­i­ty ex­pect­ed to shift from in-house man­u­fac­tur­ing to CMOs and hy­brid com­pa­nies by 2025. Sam­sung, along with Lon­za, WuXi and Fu­ji­film Diosynth Biotech­nolo­gies, will have the largest ca­pac­i­ty vol­ume, the study found.

Sam­sung is al­so se­cur­ing ad­di­tion­al land in Song­do for fu­ture plants and an open in­no­va­tion cen­ter, in ad­di­tion to lo­ca­tions over­seas to max­i­mize its large-scale bi­o­log­ics man­u­fac­tur­ing and be clos­er to its clients. Right now, its on­ly glob­al site is an R&D lo­ca­tion in San Fran­cis­co. It all aligns with the three core pil­lars of the growth plan, iden­ti­fied at the JP Mor­gan con­fer­ence: in­creas­ing man­u­fac­tur­ing ca­pac­i­ty, en­hanc­ing the di­ver­si­ty of the port­fo­lio and ex­pand­ing its foot­print abroad.

In a state­ment, Rim said:

With a steep in­crease in de­mand for med­i­cines due to the pro­longed COVID-19 pan­dem­ic, there was a great need for CD­MO ca­pa­bil­i­ties around the world to en­sure a re­li­able sup­ply of high-qual­i­ty bi­o­log­i­cal prod­ucts. By suc­cess­ful­ly man­ag­ing all po­ten­tial im­pact from the pan­dem­ic with strong busi­ness con­ti­nu­ity and op­er­a­tional ex­cel­lence, Sam­sung Bi­o­log­ics achieved sol­id growth and in­creased sales in an ex­tra­or­di­nary year and made mean­ing­ful progress in build­ing mo­men­tum around our long-term busi­ness and ca­pac­i­ty.

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.

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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Sanofi and Re­gen­eron clear the fin­ish line in an in­flam­ma­to­ry esoph­a­gus dis­ease, leav­ing Take­da in the dust

With atopic dermatitis rivals breathing down Dupixent’s neck, Sanofi and Regeneron on Friday secured a first win in new territory in what Sanofi’s head of immunology and inflammation Naimish Patel called the fastest approval he’s ever seen.

The FDA approved Dupixent on Friday to treat patients 12 years and older with eosinophilic esophagitis (EoE), an inflammatory condition that causes swelling and scarring of the esophagus. The approval came just a couple months after regulators granted Dupixent priority review, and months ahead of its PDUFA date on Aug. 3.