Fujifilm Diosynth adds on at its NC hub, bolstering lab space with plans to bring on 145 new jobs

New year, same Fu­ji­film Diosynth.

The CD­MO gi­ant hit the ground run­ning at full speed this year, an­nounc­ing it will ex­pand its Bio­Process In­no­va­tion Cen­ter in Re­search Tri­an­gle Park, NC. The move will dou­ble its ex­ist­ing lab­o­ra­to­ry foot­print in the Tar Heel State, and add an­oth­er 145 skilled jobs to the site by 2024. An­oth­er 89,000 square feet will be added, which will al­low for a more ro­bust com­mer­cial process.

The ex­pan­sion will al­so sup­port its process char­ac­ter­i­za­tion pro­grams, and com­ple­ment op­er­a­tions at its UK fa­cil­i­ty. It’s ex­pect­ed to be op­er­a­tional by 2024.

‘As lead­ers in process de­vel­op­ment, we are de­light­ed to be adding this ad­di­tion­al ca­pac­i­ty to sup­port our grow­ing pipeline of cus­tomers,’ the site’s COO Chris­tine Van­nais said in a state­ment. ‘The cut­ting-edge lab­o­ra­to­ry equip­ment and au­toma­tion tools, com­bined with the deep tech­ni­cal ex­per­tise of our sci­en­tif­ic com­mu­ni­ty will al­low us to bet­ter serve our part­ners to rapid­ly gen­er­ate and as­sess da­ta to un­der­stand com­plex mol­e­cules, along with the process­es used in their man­u­fac­ture.’

The BIC opened in May 2016 as a three-sto­ry, 62,000-square-foot fa­cil­i­ty for process in­ven­tion, de­sign and de­vel­op­ment.

The up­grade is big news for the re­gion as two de­vel­op­ers just an­nounced plans for a $1 bil­lion biotech hub in near­by Mor­risville, with enough space for both man­u­fac­tur­ing and R&D work. That site will have re­tail space and out­door recre­ation ar­eas. No fu­ture ten­ants have been named yet so far. Three weeks ago, the com­pa­ny an­nounced that it would in­vest an­oth­er $300 mil­lion in­to its Bryan-Col­lege Sta­tion, TX fa­cil­i­ty, a move that will cre­ate an­oth­er 150 jobs. That in­vest­ment will fea­ture a $1.5 mil­lion grant from the Texas En­ter­prise Fund. The ex­pan­sion will add 138,000 square feet to the cam­pus and sev­er­al 500- and 2,000-liter biore­ac­tors.

In the fall, Fu­ji­film Diosynth dumped $2 bil­lion in­to a head­quar­ters in North Car­oli­na and an­oth­er $454 mil­lion in its UK sup­ply chain. The project will re­sult in the large-scale cell cul­ture man­u­fac­tur­ing of bulk drug sub­stance. The site will have eight 20,000-liter biore­ac­tors, and the po­ten­tial to add an­oth­er 24.

CPhI ex­perts pre­dict­ed in the fall that CMOs will ac­count for four of the top five man­u­fac­tur­ing ca­pac­i­ties by the year 2025, and near­ly half of all ca­pac­i­ty will shift to large ca­pac­i­ty vol­ume. Fu­ji­film is right at the top of that list, along­side Lon­za, Sam­sung Bi­o­log­ics and WuXi Bi­o­log­ics.

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Decentralized clinical trials (DCTs) were traditionally utilized in an isolated fashion prior to the COVID-19 pandemic. To continue their research within the constraints of the pandemic, sponsors and clinical investigators pivoted to a decentralized model out of necessity. At the onset, regulatory agencies offered some guidance on the digital approaches that are acceptable to ensure DCT approaches are applied in a way that maintains patient safety, as well as data quality and integrity.

Exscientia CEO Andrew Hopkins and Sanofi CEO Paul Hudson

Drug R&D has for years had an abysmal track record of success, with the vast majority of drug candidates never making it to market. The promise of AI to shorten the discovery time for new drugs and up their chances of success has more big drugmakers buying in — and Sanofi is the latest.

Sanofi will pay $100 million upfront with a potential $5.2 billion in downstream milestones for access to up to 15 small molecule drugs from Exscientia, a red-hot UK deep learning company at the forefront of the so-called ‘AI-discovered’ drug R&D movement, the partners said Friday.

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Scott Clarke, Ambagon Therapeutics CEO

The saying goes necessity is the mother of invention — and few areas of drug development are in greater need than oncology. A new startup is now repurposing promising technology to tackle the hardest-to-drug proteins, and a suite of big-name backers are buying in.

Ambagon Therapeutics launched Friday with an $85 million A round and a world-class group of researcher-founders building what are known as ‘molecular glues’ to crack the code on a class of elusive cellular proteins, the biotech said.

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A district court in Texas will likely tie up the FDA’s FOIA office for months, as the court ruled late Thursday that the agency must release all documents related to its review of Pfizer-BioNTech’s Covid-19 vaccine.

The order from district judge Mark Pittman, handed down late Thursday, notes that while the Court recognizes the ‘unduly burdensome’ challenges that this FOIA request may present to the FDA, there also ‘may not be’ a more important issue at the FDA right now than the pandemic, the Pfizer vaccine, getting every American vaccinated, and making sure to the American public that the process was not rushed.

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Aligos Therapeutics took a beating Thursday after reporting it is stopping development on its lead program for chronic hepatitis B.

The biotech’s shares $ALGS closed down 57% and fell into penny stock territory Thursday, following a morning press release saying Aligos’ ALG-010133 program did not prove efficacious at the dose tested in a Phase I study. Additionally, the company concluded that higher doses were also unlikely to be effective, and ultimately decided to axe the candidate altogether.

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Roger Perlmutter, Eikon CEO

Roger Perlmutter hasn’t wasted any time since announcing his supposed retirement from Merck in October 2020. After leaving his perch as one of the most successful R&D chiefs in Big Pharma, he’s now snatching a cool half-billion dollars to develop ‘a battery of innovative tools’ for drug discovery at the young startup Eikon Therapeutics.

Eikon closed on a $517.8 million Series B round on Thursday morning, bringing the Hayward, CA-based company’s total raise to more than $668 million.

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Eric Easom, CEO of AN2 Therapeutics

After starting up with a $12 million Series A in 2019, California outfit AN2 Therapeutics issued its first press release in over 2 years — and its second ever: The ultra-quiet biotech has raised an $80 million Series B and added a pair of directors to boot.

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Cytokinetics stumbled a bit with its closely watched lead heart drug over the last year or so, losing two pharma partners after missing a key secondary endpoint in a Phase III study. But things are looking up in 2022, as Royalty Pharma is reaching a little deeper into its wallet to bolster that program and another heart candidate.

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Merck signed a pair of collaborations with Absci aiming to bolster its AI research capabilities, the companies announced Friday. The first is a relatively modest deal on Merck’s end — there are no details about the upfront or milestone payments but the duo said it could lead to more.

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