Over the past two years, the Ohio-based gene ther­a­py man­u­fac­tur­er Forge Bi­o­log­ics has man­aged to get a large amount of cap­i­tal to scale up its AAV pro­duc­tion ca­pa­bil­i­ties. And as the field con­tin­ues to grow, the com­pa­ny looks to grow along with it.

The com­pa­ny an­nounced Mon­day that it has raised $90 mil­lion in a Se­ries C fund­ing round, bring­ing the to­tal amount raised so far to $330 mil­lion. In an in­ter­view with End­points News, Forge Bi­o­log­ics CEO Tim Miller said that the round it­self took on­ly a few months to put to­geth­er as firms had ap­proached Forge to par­tic­i­pate.

As for what the round is go­ing to­ward, Miller told End­points that the fund­ing raise is meant to help ac­cel­er­ate ad­di­tion­al client of­fer­ings. Miller said that as reg­u­la­to­ry bod­ies be­come more strin­gent on how they look at gene ther­a­py prod­ucts, the com­pa­ny is help­ing to try to ad­dress that by putting in an au­to­mat­ed fill along with oth­er el­e­ments the com­pa­ny is plan­ning to put in on the front end of its AAV man­u­fac­tur­ing process.

Miller al­so said that funds are al­so ear­marked for adding pro­pri­etary tech­nol­o­gy that the com­pa­ny has been work­ing on as well as boost­ing Forge’s man­u­fac­tur­ing sys­tems and cell line de­vel­op­ment. The com­pa­ny will add more 5,000-liter biore­ac­tors to sup­port its AAV clients.

“There are al­most 400 ac­tive clin­i­cal tri­als in gene ther­a­py right now. And AAV is still the ma­jor­i­ty of vec­tor for gene ther­a­peu­tic ap­proach­es,” Miller told End­points. “So, for us, it’s about ex­pand­ing in­to those 5000-liter biore­ac­tors, those of the largest biore­ac­tors in the in­dus­try for sus­pen­sion-based growth. And, you know, as we ramp those up in 2023, it’s re­al­ly ex­cit­ing to see that there are groups that are al­ready look­ing at us­ing those for their larg­er pa­tient pop­u­la­tions.”

He al­so added that Forge is plan­ning to hire ag­gres­sive­ly on the back of the raise. With the com­pa­ny sit­ting at a head­count of around 250, Miller plans to add an­oth­er 50 to 75 em­ploy­ees in the next 12 months to help meet de­mand.

Forge’s 200,000 square-foot space in Colum­bus, OH, along with its 20 GMP suites, en­ables the com­pa­ny to ex­pand in­ter­nal­ly and to meet de­mand when need­ed so any more phys­i­cal build­outs are not in the cards cur­rent­ly.

In terms of any po­ten­tial fu­ture fund­ing or an IPO, Miller said that the com­pa­ny is cur­rent­ly bring­ing in rev­enue, al­low­ing the com­pa­ny to be more strate­gic with tak­ing on new rounds of fund­ing.

In 2020, the com­pa­ny re­ceived a $40 mil­lion Se­ries A from the PXV Fund. In 2021, the com­pa­ny got an even big­ger boost as it racked up a $120 mil­lion Se­ries B.

The Colum­bus area has al­so been grow­ing for biotech man­u­fac­tur­ing as Am­gen broke ground on a $365 mil­lion plant in New Al­bany, OH last year. In May, Am­pli­fy­Bio re­ceived $150 mil­lion to es­tab­lish a new 350,000 square-foot fa­cil­i­ty.

The round for Forge was led by Dri­ve Cap­i­tal and Ais­ling Cap­i­tal, along with a strate­gic in­vestor who was not dis­closed.

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.