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.

Sta­da to place $50M+ in­vest­ment in a new fa­cil­i­ty in Ro­ma­nia

While Romania may conjure up images of vast mountain ranges and tales of medieval kings, one generic manufacturer has broken ground on a new facility there.

German pharma company Stada said Monday that it has placed a €50 million ($51.9 million) investment into a 100,000 square-meter (1.08 million square-foot) site in Turda, Romania, a city in the Southeast of the country. According to a Stada spokesperson in an email to Endpoints News, the company has developed only 281,500 square feet of the site so far.

Vac­cine doc­u­ments, young lead­ers and mar­ket tur­moil: End­points' 10 biggest sto­ries of 2022

It’s been a volatile year in the world of biopharma. Market declines reset M&A valuations, and may be beginning to tempt bigger buyers back into dealmaking. Russia’s war in Ukraine disrupted drug sales and clinical trials. A new generation of young biotech leaders emerged in the Endpoints 20(+1) Under 40. And as capital runs dry in a tough environment for raising new funds, companies big and small are taking a look at their headcounts and operations for ways to make it through lean times.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.

That stinging early rebuke pointed straight down the path to a corrosive in-house agency review of Spectrum’s attempt to land an accelerated approval for the oral EGFR TKI and a public whipping that included a classic takedown by none other than Richard Pazdur, who slammed the company for “poor drug development” that led to confusion over the dose needed for a slice of NSCLC patients harboring HER2 exon 20 insertion mutations.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

FDA tells Catal­ent to fix is­sues at two man­u­fac­tur­ing sites on its own

The CDMO Catalent will have to fix issues at two manufacturing plants in the US and Europe that were subject to inspections by the FDA this summer, giving the company room to correct the issues without facing further regulatory action.

The FDA gave Catalent a “voluntary action indicated” response to two inspections at the contract manufacturer’s site in Bloomington, IN, and Brussels, Belgium. Fixing the issues on its own is a preferable outcome to facing an “official action indicated” response, meaning that an official warning would be sent out or a sit-down with the FDA would be required.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; 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.

As you start planning for #JPM23, we hope you will consider joining Endpoints News for our live and virtual events. For those who are celebrating Thanksgiving, we hope you are enjoying the long weekend with loved ones. And if you’re not — we’ll see you next week!

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

Albert Bourla, Pfizer CEO (John Thys/POOL/AFP via Getty Images)

Pfiz­er CEO un­der fire from UK watch­dog over vac­cine com­ments — re­port

Pfizer CEO Albert Bourla told the BBC last December that he had “no doubt in my mind that the benefits, completely, are in favor” of vaccinating 5- to 11-year-olds for Covid-19. Almost a year later, those comments have reportedly landed him in trouble with a UK pharma watchdog.

Children’s advocacy group UsForThem filed a complaint with the UK’s Prescription Medicines Code of Practice Authority (PMCPA) last year accusing Bourla of making “disgracefully misleading” statements during the BBC interview, including one that “Covid in schools is thriving.” At the time, UK regulators had not yet cleared the vaccine for the 5 to 11 age group, though the vaccine did have a positive opinion from the EMA’s human medicines committee.

Sanofi's new headquarters, La Maison Sanofi, in Paris (Credit: Luc Boegly)

Sanofi wel­comes 500 staffers to new Paris HQ af­ter €30M ren­o­va­tion

When Paul Hudson took the helm at Sanofi back in 2019, he promised to reinvent the pharma giant — including its Paris headquarters. This week, the company set up shop in new “state-of-the-art” digs.

La Maison Sanofi, as the new HQ is called, is officially open for business, Hudson announced on Monday. The 9,000-square-meter (just under 97,000-square-foot) space accommodates 500 employees across the company’s government and global support functions teams, including finance, HR, legal and corporate affairs — and it was built with environmental sustainability and hybrid work in mind.

Rachael Rollins (Charles Krupa/AP Images)

US seeks jail time for co-CEO of New Eng­land com­pound­ing cen­ter af­ter dead­ly 2012 fun­gal out­break

The US attorney for the district of Massachusetts late last week called on the state’s district court to sentence the former co-owner of the now-defunct New England Compounding Center to 18 months of jail time for his role in the center’s quality deviations that led to more than 100 people dead from a fungal meningitis outbreak.

Gregory Conigliaro was convicted of conspiring with more than a dozen others at NECC to deceive the FDA and misrepresent the fact that the center was only dispensing drugs pursuant to patient-specific prescriptions.

Post-Brex­it UK trade re­port shows 'wor­ry­ing' signs for life sci­ences

The UK life sciences industry has always been a a bright spot for its American trade partners, but a new report from the UK government’s Board of Trade raises some fresh concerns about the UK life sciences in the post-Brexit environment.

The report, published Monday, showed that life science-related trade between the UK and its US and European partners declined, sometimes substantially, over the last five years. For instance, UK life sciences exports from 2016-2021 declined by 17% to Spain, -14% to Italy, -13% to Poland, and -11% to Germany.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.