Marc Casper, Thermo Fisher CEO

Ther­mo Fish­er com­pletes $76M cell cul­ture man­u­fac­tur­ing site near Buf­fa­lo, NY

Ther­mo Fish­er has com­plet­ed the ex­pan­sion of one of its man­u­fac­tur­ing fa­cil­i­ties in New York, tak­ing an­oth­er step for­ward in its broad­er in­vest­ment plan for sites in the US and glob­al­ly.

The $76 mil­lion ex­pan­sion of its dry pow­der me­dia man­u­fac­tur­ing fa­cil­i­ty in Grand Is­land, New York, just north of Buf­fa­lo, will al­low more ca­pac­i­ty to sup­port Ther­mo Fish­er’s glob­al sup­ply and ex­tend its ca­pa­bil­i­ties for ma­te­ri­als used in vac­cines and bi­o­log­ic ther­a­py de­vel­op­ment and man­u­fac­tur­ing.

The Grand Is­land ex­pan­sion was an­nounced ear­li­er last year as part of the com­pa­ny’s $650 mil­lion in­vest­ment in­to sev­er­al in­fra­struc­ture projects to in­crease its bio­pro­cess­ing pro­duc­tion. That in­vest­ment in­cludes site ex­pan­sions across the US, UK, Sin­ga­pore and Chi­na.

“Our ex­pand­ed Grand Is­land site rep­re­sents a sig­nif­i­cant mile­stone in our in­vest­ment to dou­ble our to­tal man­u­fac­tur­ing ca­pac­i­ty by the end of 2023. With the har­mo­nized ca­pa­bil­i­ties of our glob­al man­u­fac­tur­ing sites that en­able us to prove equiv­a­len­cy in man­u­fac­tur­ing, we’re able to sup­port cur­rent de­mand while prim­ing for fu­ture growth and con­tin­u­ous­ly en­hanc­ing our cus­tomer ex­pe­ri­ence glob­al­ly,” said Kate Torchilin, pres­i­dent of bi­o­log­i­cals and chem­i­cals at Ther­mo Fish­er, in a state­ment.

The ex­pan­sion adds more than 45,000 square feet of man­u­fac­tur­ing space for the pro­duc­tion of Gib­co Ad­vanced Gran­u­la­tion Tech­nol­o­gy (AGT) and dry pow­der me­dia as well as cell cul­tures and liq­uid sup­ple­ments.

Ac­cord­ing to the com­pa­ny, the ad­di­tion­al space will al­so help ac­cel­er­ate the de­vel­op­ment and pro­duc­tion of bio­ther­a­peu­tics and vac­cines, and al­low process ca­pa­bil­i­ties and equip­ment to pro­vide pro­duc­tion re­dun­dan­cy and short­en prod­uct man­u­fac­tur­ing lead times.

The Grand Is­land ex­pan­sion is ex­pect­ed to add 100 em­ploy­ees across roles in R&D, op­er­a­tions, man­u­fac­tur­ing, HR, en­gi­neer­ing and main­te­nance. Ther­mo Fish­er cur­rent­ly em­ploys more than 1,600 peo­ple at the Grand Is­land site and more than 3,000 peo­ple across the state of New York.

Ac­cord­ing to Ther­mo Fish­er, the site has been in op­er­a­tion for more than 60 years and home to Gib­co cell prod­ucts, which are wide­ly used in bio­man­u­fac­tur­ing world­wide.

Ear­li­er this year Ther­mo Fish­er opened a $44 mil­lion fa­cil­i­ty in Og­den, Utah, that will man­u­fac­ture high­ly cus­tomiz­able bio­process con­tain­er sys­tems as a part of the spend­ing spree.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Yuling Li, Innoforce CEO

In­no­force opens new man­u­fac­tur­ing site in Chi­na

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.

Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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Val­neva's chikun­gun­ya vac­cine on track for FDA nod af­ter long-term an­ti­body da­ta

The chikungunya virus met its match in Valneva’s vaccine candidate, VLA1553, according to data from an antibody persistence trial released today.

The trial found that 99% of 363 participants retained neutralizing antibodies 12 months after a single dose of vaccine in the company’s earlier, larger Phase III trial, called VLA1553-301. The participants from the long-term study will continue to be monitored for at least five years.