Kite Phar­ma gets FDA to sign off on new Cal­i­for­nia-based vec­tor man­u­fac­tur­ing fa­cil­i­ty

Kite Phar­ma just got FDA ap­proval to kick off op­er­a­tions at a new man­u­fac­tur­ing cam­pus.

The can­cer-fo­cused, CAR-T cell ther­a­py play­er made the an­nounce­ment Mon­day, say­ing that the fed­er­al reg­u­la­to­ry agency gave the green light to Kite’s 100,000 square-foot, retro­vi­ral vec­tor man­u­fac­tur­ing fa­cil­i­ty in Ocean­side, CA.

Kite’s glob­al head of tech­ni­cal op­er­a­tions Chris Mc­Don­ald tells End­points News that the fa­cil­i­ty has been in the works for about four years, af­ter Kite teamed up with its par­ent com­pa­ny Gilead. Gilead ac­quired Kite Phar­ma for just shy of $12 bil­lion in 2017.

Chris Mc­Don­ald

Kite has em­ployed 100 work­ers fo­cused on vi­ral vec­tors in the fa­cil­i­ty, and since the build­ing is lo­cat­ed on Gilead’s cam­pus, the par­ent phar­ma will be pro­vid­ing lo­gis­ti­cal sup­port, such as cafe­te­ria staff and build­ing se­cu­ri­ty. The build­ing al­so touts two man­u­fac­tur­ing suites: One is ful­ly ded­i­cat­ed on retro­vi­ral vec­tors in cur­rent com­mer­cial prod­ucts, and the oth­er is set aside for fu­ture ex­pan­sion for pipeline prod­ucts and po­ten­tial­ly dif­fer­ent types of vec­tors.

Vi­ral vec­tors, ac­cord­ing to Mc­Don­ald, are a key in­gre­di­ent need­ed for Kite to make the CAR-T cell ther­a­pies that the biotech has got­ten ap­proved to make for pa­tients, such as Yescar­ta and Tecar­tus. The vec­tors are the in­gre­di­ent that en­code the chimeric anti­gen re­cep­tor in­to a pa­tient’s T cells.

Mc­Don­ald added that the Gilead sub­sidiary is look­ing at au­tomat­ing part of the man­u­fac­tur­ing process so that Kite can be­come more ef­fi­cient. Per Mc­Don­ald:

I think right now, if you went in­to any lab in any uni­ver­si­ty, you’re gonna see staff work­ing un­der a biosafe­ty cab­i­net, you know, mak­ing prod­ucts, etc. And it’s a very man­u­al process and staff are bound quite a bit in asep­tic gown­ing. What we’re work­ing on is re­al­ly de­vel­op­ing an au­toma­tion plat­form that will take a lot of the man­u­al steps away and au­to­mate them and al­so close the man­u­fac­tur­ing process, so that we don’t have to op­er­ate asep­ti­cal­ly, which is a huge ben­e­fit for our staff  — dri­ves a lot of ef­fi­cien­cy.

The op­er­a­tions chief not­ed that this was just on the man­u­fac­tur­ing side. On top of that, the phar­ma is in­ves­ti­gat­ing po­ten­tial op­tions to au­to­mate qual­i­ty con­trol test­ing, as every batch Kite makes is for on­ly one pa­tient.

The Ocean­side site is just the newest ad­di­tion to Kite’s group of man­u­fac­tur­ing fa­cil­i­ties — in­clud­ing oth­ers in Cal­i­for­nia, the Nether­lands, and in Mary­land.

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.

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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.

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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.

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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!

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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.

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.

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Merck targets vaccine-hesitant parents in its latest 'Why Vaccines' campaign. (Image: Shutterstock)

Mer­ck­'s lat­est 'Why Vac­ci­nes' cam­paign seeks to bet­ter in­form vac­cine-hes­i­tant moms

From Hollywood couple endorsements to targeted equity efforts, Merck has been pushing the value of vaccinations, especially since the Covid-19 pandemic disruption. Now the pharma is turning to a new target — vaccine-hesitant parents, and moms in particular.

Merck’s “Why Vaccines” latest social media and digital campaign spotlights real-life new moms who have questions about vaccinating their children.

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