Fu­ji­film's CD­MO carves foothold in Boston biotech hub with new HQ fo­cused on vi­ral vec­tors, gene ther­a­pies

On the heels of a red-let­ter year for con­tract man­u­fac­tur­ers, Japan’s Fu­ji­film has seen its CD­MO arm — Fu­ji­film Diosynth Biotech­nolo­gies — earn in­ter­est from ma­jor Covid-19 vac­cine mak­ers for its vi­ral-vec­tor ca­pa­bil­i­ties. Now, the drug­mak­er is look­ing to lock down its US foot­print in the bustling Boston biotech hub.

Fu­ji­film will in­vest rough­ly $40 mil­lion (or 4 bil­lion yen) in a new head­quar­ters in the greater Boston area for its CD­MO arm, which will al­so func­tion as its third vi­ral-vec­tor man­u­fac­tur­ing site.

The Boston fa­cil­i­ty, Fu­ji­film’s sec­ond US lo­ca­tion, is set to be­gin process de­vel­op­ment analy­ses and ex­per­i­ments for con­di­tion­ing cell cul­ti­va­tion by the fall of 2021. The ca­pac­i­ty for drug sub­stance man­u­fac­tur­ing in ear­ly-stage clin­i­cal tri­als will come lat­er, in fall 2023, the com­pa­ny said in a press re­lease.

Fu­ji­film al­so has a vi­ral-vec­tor plant in Texas — that fa­cil­i­ty opened in 2014 and has since un­der­gone a $120 mil­lion ex­pan­sion to fur­ther in­crease man­u­fac­tur­ing ca­pac­i­ty. In Oc­to­ber, the com­pa­ny al­so an­nounced plans for a gene ther­a­py site in the UK, which it said would be op­er­a­tional by this spring.

The ef­forts to ramp up its im­pact in vi­ral-vec­tor ther­a­peu­tics is the lat­est in Fu­ji­film’s years-long in­vest­ments across bio­phar­ma man­u­fac­tur­ing. In 2017, the spot­light was on ex­pand­ing mon­o­clon­al an­ti­body fa­cil­i­ties, and the year af­ter, the con­glom­er­ate ven­tured to re­gen­er­a­tive med­i­cine by buy­ing two com­pa­nies spe­cial­iz­ing in cell-cul­ture me­dia.

Now, the newest CD­MO in­vest­ment is aimed at an ul­ti­mate goal of ful­fill­ing un­met med­ical needs, Fu­ji­film se­nior ex­ec­u­tive vice pres­i­dent Takatoshi Ishikawa said in a state­ment.

“The strength of Fu­ji­film’s Bio CD­MO busi­ness lies in its wide-range of ca­pa­bil­i­ties: process de­vel­op­ment for a va­ri­ety of bio­phar­ma­ceu­ti­cal such as an­ti­bod­ies, re­com­bi­nant pro­tein, gene ther­a­py, vac­cines, on­colyt­ic virus and more, along with flex­i­ble fa­cil­i­ties that can adapt to small or large scale man­u­fac­tur­ing of drug sub­stances, for­mu­la­tion and pack­ag­ing,” he said.

Fu­ji­film — par­ent com­pa­ny, not the CD­MO — in re­cent months has pur­sued a Covid-19 niche for flu drug Avi­gan, a drug thought ear­ly in the Covid-19 pan­dem­ic to be promis­ing. Two weeks ago, how­ev­er, the Japan­ese health min­istry de­ter­mined that it found da­ta on the drug’s ef­fec­tive­ness to be in­con­clu­sive.

Al­so known as favipi­ravir, the drug showed im­prove­ment in non-se­vere Covid-19 cas­es af­ter 11.9 days, short­er than the 14.7 days for those in a place­bo group, ac­cord­ing to a 156-per­son tri­al test. Per Japan­ese me­dia re­ports, though, the tri­al was open-la­bel and some of the cri­te­ria were un­clear, lead­ing to the hes­i­tan­cy from state reg­u­la­to­ry agen­cies.

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.

Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”

JP Gabriel, Ocugen

JP Gabriel watched from the bleach­ers as the pan­dem­ic raged. Now head of sup­ply chain at Ocu­gen, he's ready to bat

The world was in the middle of the most pressing public health risk his generation had ever seen, and JP Gabriel felt like he was sitting on the sidelines. As a VP of biologics and mRNA manufacturing at Ultragenyx, Gabriel watched from the sidelines as players like Pfizer/BioNTech and Moderna used mRNA tech to chase their own Covid-19 vaccines.

This month, Gabriel got the chance to get his hands dirty against the pandemic — but it won’t be with mRNA.

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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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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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Covid-19 man­u­fac­tur­ing roundup: Mary­land looks to grow biotech ca­pac­i­ty with $400M check; Rus­sia lands sec­ond Sput­nik V part­ner this week

A Maryland real estate project has added three new biotech-focused manufacturing and research buildings to an office park to keep up with demand created by the pandemic, the Washington Business Journal reported.

The Milestone Business Park — located off of I-270 in Germantown, MD — will see the new buildings and a total of 532,000 square feet as the campus rebrands to Milestone Innovation Park.

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.

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