A Penn­syl­va­nia CD­MO spe­cial­iz­ing in cell and gene ther­a­py man­u­fac­tur­ing is re­ceiv­ing a big in­flux of cash from a South Ko­re­an drug­mak­er — and it has plans for a ma­jor hir­ing spree.

SK, the hold­ing com­pa­ny of SK bio­science, will in­vest $350 mil­lion of eq­ui­ty fi­nanc­ing in­to the Cen­ter for Break­through Med­i­cines, with plans to add an ad­di­tion­al 2,000 em­ploy­ees as part of a re­dux at the CD­MO’s King of Prus­sia, PA fa­cil­i­ty.

CBM will use the funds to add au­toma­tion to its man­u­fac­tur­ing op­er­a­tions from pre-clin­i­cal all the way through com­mer­cial scale. That in­cludes process de­vel­op­ment, vi­ral vec­tor man­u­fac­tur­ing, cell pro­cess­ing, plas­mid DNA and cell bank­ing, it said. The com­pa­ny will bring 700,000 ad­di­tion­al square feet of ca­pac­i­ty on­line and hire staff mem­bers for its site out­side Philadel­phia. The space will be run by The Dis­cov­ery Labs.

Bri­an O’Neill

The deal has been in the works since last Jan­u­ary. It comes eight months af­ter SK’s takeover of the French gene and cell ther­a­py com­pa­ny Yposke­si.

CBM was es­tab­lished in 2019. It an­nounced over the sum­mer that it would in­vest $132 mil­lion in pro­duc­tion ca­pac­i­ty in mR­NA and vi­ral vec­tor op­er­a­tions in a project set to be op­er­a­tional by 2024. That ex­pan­sion will add more than 1 mil­lion square feet of pro­duc­tion space in An­dong, South Ko­rea, and was the first site in the coun­try to get the OK for Covid-19 vac­cine man­u­fac­tur­ing on the con­ti­nent.

“We chose to part­ner with SK based on our shared deep de­sire to cure can­cer and erad­i­cate ge­net­ic dis­ease,” CBM chair­man Bri­an O’Neill said in a state­ment. “Thou­sands of peo­ple are dy­ing every day, and we have the abil­i­ty to cure pa­tients by man­u­fac­tur­ing these new tech­nolo­gies.

Dong Hoon Lee

The move is a step in the right di­rec­tion for SK Pharmte­co to be­come a top-tier CD­MO by 2025, Dong Hoon Lee, the EVP of SK, said in a state­ment.

In Au­gust, South Ko­re­an Pres­i­dent Moon Jae-in said that he hopes the coun­try can be­come one of the five largest man­u­fac­tur­ing bases in the world by 2025. Moon added biotech man­u­fac­tur­ing to the list of na­tion­al strate­gic tech­nolo­gies along with semi­con­duc­tors and bat­ter­ies and of­fers tax breaks for those com­pa­nies to help pay for ma­te­ri­als, parts and equip­ment.

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Mustang Bio is in familiar territory, but that isn’t a place it necessarily wants to be.

The FDA has placed a hold on Mustang Bio’s pivitol trial for its gene therapy to treat patients with bubble boy disease, citing issues surrounding chemistry, manufacturing and controls clearance. It’s the second hold due to CMC issues the company has received in roughly 18 months.

An investigational new drug application was submitted in December 2021. If granted an IND, a Phase II study will then assess safety, tolerability and efficacy of MB-207. If approved by the FDA, the therapy would one day be eligible for a rare pediatric disease voucher.

The summer before Cellino CEO and co-founder Nabiha Saklayen started at Harvard, she lost her grandmother following complications to diabetes. Before then, she hadn’t taken a biology class since ninth or tenth grade — the mark of a classic physicist — but it was then she decided she wanted the rest to sit at the intersection of the two for the rest of her career

Combine that with being across the way from the University’s stem cell institute in Cambridge, and you get the birth of Cellino, an autonomous cell therapy manufacturing company that just announced the closing of its Series A.

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.