Fu­ji­film's CD­MO arm plots mas­sive $2B plant in the US for broad range of ther­a­peu­tics

Buoyed by in­ter­est from ma­jor Covid-19 vac­cine mak­ers for its vi­ral-vec­tor ca­pa­bil­i­ties, Fu­ji­film’s CD­MO arm has looked to rapid­ly build its US foot­print to meet de­mand. Now, just days af­ter un­veil­ing plans for a new HQ in the Boston area, Fu­ji­film is putting down a mas­sive down pay­ment on an­oth­er US site.

Fu­ji­film will spend $2 bil­lion by 2025 to build a large-scale cell cul­ture pro­duc­tion plant near one of its ex­ist­ing fa­cil­i­ties as the Japan­ese CD­MO looks to ex­pand and scale its US foot­print. The newest plant will help boost Fu­ji­film Diosynth Biotech­nolo­gies’ cu­mu­la­tive growth by 20% by March 2026, the com­pa­ny said.

Fu­ji­film said in a press re­lease Thurs­day that the fa­cil­i­ty will be built as an ex­ten­sion of an ex­ist­ing US site, but didn’t pro­vide fur­ther de­tails. Grant­ed, that doesn’t leave too many op­tions, as Diosynth Biotech­nolo­gies cur­rent­ly op­er­ates on­ly in Col­lege Sta­tion, Texas, and Mor­risville, North Car­oli­na.

On Tues­day, the con­glom­er­ate an­nounced a new head­quar­ters in the bustling Boston area, which will be­gin lim­it­ed vi­ral-vec­tor man­u­fac­tur­ing op­er­a­tions lat­er this year be­fore it’s ful­ly op­er­a­tional in 2023.

A com­pa­ny spokesper­son told End­points News in an email Thurs­day that no fur­ther de­ci­sions have been made on where ex­act­ly the site will be.

Re­gard­less, it sig­ni­fies a marked ex­pan­sion for Fu­ji­film, which has sought since 2017 to in­crease its foot­print in the bio­phar­ma man­u­fac­tur­ing realm. That year, the spot­light was on ex­pand­ing mon­o­clon­al an­ti­body fa­cil­i­ties, and in 2018, the con­glom­er­ate ven­tured to re­gen­er­a­tive med­i­cine by buy­ing two com­pa­nies spe­cial­iz­ing in cell-cul­ture me­dia. More re­cent ex­pan­sions, in­clud­ing Tues­day’s, in­di­cate a more gen­er­al fo­cus on meet­ing un­met med­ical needs.

Ken­ji Sukeno

With the new site sched­uled to be­gin op­er­a­tions in the spring of 2025, the CD­MO will have a drug sub­stance pro­duc­tion line ca­pac­i­ty of eight 20,000-liter biore­ac­tors for mam­malian cells, a ful­ly au­to­mat­ed fill-fin­ish sys­tem, and a pack­ag­ing line for as­sem­bling sy­ringes and au­to­mat­ic-pack­ag­ing equip­ment.

“The Unit­ed States is the world’s biggest mar­ket for bio­phar­ma­ceu­ti­cals,” Fu­ji­film Pres­i­dent Ken­ji Sukeno said in a state­ment. “I am pleased that through this large in­vest­ment in the U.S.A we are able to sup­port the de­vel­op­ment and man­u­fac­tur­ing of new drugs that can help ful­fill un­met med­ical needs.”

Mar­tin Mee­son

Fu­ji­film Diosynth Biotech­nolo­gies CEO Mar­tin Mee­son said the newest fa­cil­i­ty will house the ca­pac­i­ty to turn out a broad range of ther­a­pies in the com­ing years.

“We are lever­ag­ing our strengths in process de­vel­op­ment and man­u­fac­tur­ing for a wide range of bio­phar­ma­ceu­ti­cals such as an­ti­bod­ies, re­com­bi­nant pro­teins, gene ther­a­pies and vac­cines,” he said.

Fu­ji­film said it’s set a tar­get of $2 bil­lion by its fis­cal year end­ing in March 2025 for its fa­cil­i­ties in Col­lege Sta­tion and Teesside, UK. By the fol­low­ing year, it ex­pects the afore­men­tioned 20% growth rate to kick in.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Werner Lanthaler, Evotec CEO

Evotec strength­ens its French con­nec­tion, pledg­ing to drop $120M in­to Toulouse plant for Covid-19 an­ti­bod­ies

Much of the recent focus on manufacturing capacity for Covid-19 has been on vaccines, and for good reason, too. But countries are also hoping to build a big enough footprint to produce pandemic-level monoclonal antibodies, and now France is working with Germany’s Evotec to stay prepared.

Evotec will lay out $120 million with a $60 million boost from multiple French governments and investors to build a new biologics facility in Toulouse that will expand its capacity to produce therapeutic antibodies for Covid-19, the German CDMO and biotech said this week.

Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Bay­er plots a ma­jor facelift at Berke­ley cam­pus, un­cork­ing a 30-year, $1.2B plan to dri­ve cell and gene ther­a­pies

Bayer first set roots in Berkeley back in 1974, when it was still operating as Miles Labs. The site has pumped out three hemophilia A treatments for distribution worldwide; but now, as the pharma continues its cell and gene therapy push, it has something bigger in mind.

Bayer is planning a 30-year revamp at the campus, which includes 918,000 square feet in new buildings and double the jobs, according to a report by the Bay Area Council Economic Institute.

LLS backs 5 new can­cer drug projects with up to $50M; Trodelvy con­tin­ues to im­press with more TNBC da­ta

The Leukemia and Lymphoma Society has tapped 5 new early-stage projects to back with up to $10 million each in fresh investments. The 5 biotechs are:

— Caribou, headed by Rachel Haurwitz and co-founded by Jennifer Doudna, is working on next-gen, off-the-shelf CAR-Ts to replace the patient-derived cells now in use.

— The LLS supported NexImmune’s IPO, helping fund its work on nanoparticles that can gin up an immune response directed at cancer cells. The biotech has 2 projects now in Phase I trials.

Steffen Schuster, ITM CEO

Ra­dio­phar­ma re­mains hot as Ger­many's ITM rais­es $109M to ad­vance neu­roen­docrine can­cer pro­gram

The world of radiopharmaceuticals has been heating up over the last few years, and Thursday saw another company focused on the field pull in a new nine-figure raise.

Germany’s ITM, or Isotopen Technologien München, scored a $109 million round of loan financing to push forward its precision oncology pipeline and fund late-stage development for its lead program. As part of the agreement, the loan will convert to shares in the event of future financial or corporate transactions, ITM said.