Fu­ji­film con­tin­ues CD­MO ex­pan­sion, break­ing ground on $435M UK site

Fu­ji­film’s CD­MO arm, Fu­ji­film Diosynth, has been on a roll this month as the com­pa­ny has re­cent­ly bro­ken ground on a ma­jor project in Eu­rope and it ap­pears to be keep­ing up the mo­men­tum.

Fu­ji­film Diosynth an­nounced that it has kicked off an ex­pan­sion project for its mi­cro­bial man­u­fac­tur­ing fa­cil­i­ty at its cam­pus in the town of Billing­ham, UK, in the north­east of Eng­land.

The 20,000 square-foot, £400 mil­lion ($435 mil­lion) ex­pan­sion will add clean rooms, pu­rifi­ca­tion suites and a pack­ing area along with more space for the man­u­fac­tur­ing it­self.

Ac­cord­ing to Fu­ji­film Diosynth, the project is slat­ed to be com­plet­ed at the end of next year or the be­gin­ning of 2024 and will boost the man­u­fac­tur­ing ca­pac­i­ty by 70%. Once com­plet­ed, it will al­so look to cre­ate around 350 jobs.

When the ex­pan­sion was an­nounced last year, the site was ex­pect­ed to fea­ture four 2,000L biore­ac­tors and two 500L sin­gle-use biore­ac­tors to make mon­o­clon­al and nov­el an­ti­body treat­ments in a cell cul­ture fa­cil­i­ty.

Paul Found

“Through in­no­va­tion and the uti­liza­tion of high-through­put tech­nolo­gies, we con­tin­u­al­ly strive to in­crease our renowned mi­cro­bial process de­vel­op­ment ser­vices to com­ple­ment our ex­ten­sive man­u­fac­tur­ing ex­pe­ri­ence,” Paul Found, the COO of the UK site, said in a state­ment.

This comes as Fu­ji­film Diosynth kicked off the con­struc­tion for a $1.6 bil­lion ex­pan­sion project at the com­pa­ny’s site in Den­mark to in­crease cell cul­ture pro­duc­tion as well as to boost ca­pa­bil­i­ties at a fa­cil­i­ty in Texas. The com­pa­ny is al­so look­ing to make an in­vest­ment of $850 mil­lion to­tal across its sites in the US and the UK.

Fu­ji­film’s Billing­ham fa­cil­i­ty has al­so been a key play­er in Covid-19 vac­cine pro­duc­tion, serv­ing as No­vavax’s con­tract part­ner in pro­duc­ing the anti­gen com­po­nent for its vac­cine.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Rahul Singhvi, Resilience CEO

Q&A: Re­silience boss Rahul Singhvi talks $2B US bio­man­u­fac­tur­ing ini­tia­tive and post Se­ries D deals

When the Biden administration announced last week, through an executive order, that it is investing $2 billion into domestic efforts to increase biotechnology and biomanufacturing efforts, a lot of ears perked up in the wider manufacturing world. Funding is going towards manufacturing infrastructure, training, R&D and security measures, among others, something that domestic manufacturers are bullish about.

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An­oth­er Cipla site lands a Form 483 over clean­ing is­sues and QC con­trols

A Cipla drug manufacturing site in India has once again landed in the crosshairs of FDA inspectors.

The facility in question is Cipla’s drug manufacturing facility in the village of Verna, in the state of Goa in India’s southwest. In a sign that foreign inspections might ramp up again, the FDA’s visit from Aug. 16 to Aug. 22 uncovered six observations.

The 11-page report noted that environmental monitoring at the site did not properly ensure that microbial contaminants were not making any impact in the aseptic filling areas. It also found that procedures meant to stop microbial contamination were not adequately conducted in aseptic areas of the facility.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Phil Sharp, Nobel Prize laureate (L), and John Carroll, Endpoints News co-CEO (via Michael Last)

The End­points 11: Fire­side chat with No­bel Prize lau­re­ate Phil Sharp

On Thursday evening in Boston I had the great good fortune to talk about the creation of the biotech industry with Nobel Prize-winning scientist Phil Sharp. I learned quite a bit about the early days of Genentech, Biogen and Alnylam, which all helped birth this unusual drug development ecosystem. And that’s why we can do things like the Endpoints 11. Here’s my talk with Phil Sharp, which you can either watch or read below.

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Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.