The small city of San­ford, NC, was once known for its brick pro­duc­tion, but now is quick­ly be­com­ing a hub in the biotech world. And now Astel­las is the lat­est to pitch its tent in the area.

The com­pa­ny’s gene ther­a­py branch, which came out of the ac­qui­si­tion of Au­dentes in 2019, has opened a new man­u­fac­tur­ing fa­cil­i­ty in the city, com­pris­ing 135,000 square feet and shelling out $100 mil­lion. Astel­las de­signed the site to pro­vide clin­i­cal and com­mer­cial-scale man­u­fac­tur­ing ca­pa­bil­i­ties for its pipeline of AAV vec­tors for gene ther­a­pies, which in­cludes pro­grams from both Astel­las and Au­dentes’ port­fo­lios.

Wednes­day’s in­vest­ment will al­so sup­port glob­al sup­ply chain needs and in-house qual­i­ty con­trol test­ing, as well as the cre­ation of more than 200 jobs through 2026. Cur­rent­ly, around 50 peo­ple are al­ready em­ployed at the site.

Math­ew Pletch­er, di­vi­sion head of gene ther­a­py re­search and tech­ni­cal op­er­a­tions at Astel­las, said that San­ford is a good lo­ca­tion be­cause it can pro­vide enough space for the ini­tial build, but is al­so large enough for any fu­ture ex­pan­sions if need­ed. Pletch­er al­so said this move puts Astel­las in an area that is quick­ly be­com­ing a ma­jor hub for ge­net­ic med­i­cine and man­u­fac­tur­ing.

Its new fa­cil­i­ty is just down the road from a 230-acre Pfiz­er man­u­fac­tur­ing site that has been heav­i­ly in­vest­ing in gene ther­a­py ca­pa­bil­i­ties, ac­cord­ing to a re­port from NCbiotech. In 2021, Abzena al­so se­lect­ed San­ford for a $200 mil­lion bi­o­log­ics plant that will even­tu­al­ly house around 24,000 square feet of biore­ac­tor ca­pac­i­ty.

“This area of North Car­oli­na is quick­ly be­com­ing a hub of ge­net­ic med­i­cine and man­u­fac­tur­ing, and so you can look at it two ways. Yes, that cre­ates some com­pe­ti­tion for the work­force, but it al­so speaks to the fact that now there is a re­al nu­cle­us of ex­per­tise be­ing gen­er­at­ed,” Pletch­er said.

As to why Astel­las felt it need­ed the plant, Pletch­er said the com­pa­ny rec­og­nizes that AAV man­u­fac­tur­ing re­mains a choke point for the in­dus­try, stat­ing there are still lim­i­ta­tions when it comes to both ca­pa­bil­i­ty and ca­pac­i­ty. And as Astel­las moves its ther­a­pies to­ward the clin­ic, the com­pa­ny will need more ac­cess to clin­i­cal-grade ma­te­r­i­al that can sup­port a glob­al roll­out.

“Just to make the ma­te­r­i­al… at cost and to meet the goals and the needs of our grow­ing port­fo­lio, we were go­ing to need more than what we had in South San Fran­cis­co,” he said.

Pletch­er al­so not­ed the new fa­cil­i­ty places Astel­las near ma­jor col­le­giate in­sti­tu­tions such as Duke and the Uni­ver­si­ty of North Car­oli­na. While no for­mal re­la­tion­ships have been forged, Pletch­er hopes to lever­age this con­nec­tion to both iden­ti­fy tal­ent and pos­si­bly forge more aca­d­e­m­ic part­ner­ships.

And while the com­pa­ny is com­mit­ted to its new lo­ca­tion, their South San Fran­cis­co fa­cil­i­ty will con­tin­ue to play a ma­jor role. San­ford will fo­cus pri­mar­i­ly on clin­i­cal sup­ply and even­tu­al com­mer­cial sup­ply, while the Cal­i­for­nia site can work to help sup­port its ear­ly port­fo­lio, as it is clos­er to the cell and gene ther­a­py re­search hub.

Pletch­er sees the new plant as not just a way to roll out gene ther­a­py el­e­ments, but as a way to en­gage the biotech in­dus­try as a means to part­ner with small­er com­pa­nies.

“The scale and the scope of the in­vest­ment that Astel­las is mak­ing in gene ther­a­py, as rep­re­sent­ed by this fa­cil­i­ty, just speaks to its com­mit­ment to the space and the vi­sion of the im­por­tance of gene ther­a­py and the fu­ture of med­i­cine,” he said. “And then ul­ti­mate­ly, what this site al­lows us to do is to think glob­al­ly, to think broad­ly, to think about where we can take our port­fo­lio and plat­form with­out hav­ing some of the lim­i­ta­tions that I think, par­tic­u­lar­ly in the biotech space, re­al­ly squeeze a lot of those com­pa­nies.”

Just as scientific innovation is essential to advancing health, systemic healthcare innovation is required to tackle health disparities. Factors outside of science – such as racism, discrimination, and lack of access to quality health care – create barriers that prevent some people from benefiting from hard-won scientific advancements. Innovation must go beyond science to address disparities in cancer care.

The last few decades have been years of amazing progress in how we approach cancer care: emphasizing regular screenings, early diagnoses and treatment with targeted therapies that are helping many patients live longer and healthier than ever before. We in the oncology community are proud of the hope we’ve brought to people facing this disease. However, the pandemic brought to light how health disparities can set us back from achieving our ultimate goal of eliminating cancer as a cause of death.

The new GSK has a new look. In a blend of familiar and modern, its vibrant orange brand color remains, while the now three letter-only name has been reimagined in a curvy contemporary logo update.

While the logo is the most visible change, the new GSK brand debuting Thursday is more than just a makeover. It’s a wholesale change for the 300-year-old company that, for the first time in its history, is no longer in the consumer healthcare business. The biopharma-only GSK has adopted a new purpose “to unite science, technology and talent to get ahead of disease together” as well as a new strategy, ambitions and revamped brand identity.

Regenxbio is pushing deeper into the gene therapy space with the opening of a new facility at its campus in the Washington D.C., suburb of Rockville, MD.

Built in a year, the $65 million, 132,000-square-foot GMP facility will enable the company to boost its manufacturing of NAV Technology-based adeno-associated virus, or AAV, vectors at scales up to 2,000 liters. The facility will also implement Regenxbio’s platform suspension cell culture process.

Emma Walmsley’s bet on making GSK a pure play Big Pharma innovator just cleared a major milestone. But the GSK team is not home free yet.

The global player announced that its adult RSV vaccine cleared a Phase III trial — AReSVi 006 — offering “exceptional protection” to 25,000 enrollees over the age of 60, setting up a planned rollout with regulators. But while GSK cheered this as a clear success, and a landmark first, it’s keeping the key figure on efficacy in preventing severe infections under wraps for now, leaving the next big question of how this will look to regulators and industry rivals still unanswered.

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For the second straight day, the FDA’s Cellular, Tissue and Gene Therapies adcomm voted unanimously in favor of FDA approving a bluebird bio gene therapy, this time by a 13-0 vote in favor of beti-cel as a potential treatment for a blood disorder known as β-thalassemia for those who require regular blood transfusions.

The second straight unanimous thumbs up opens the potential for two FDA approvals later this summer for bluebird — although the agency on Friday raised some manufacturing concerns for both therapies.

The UK’s National Institute for Health and Care Excellence, or NICE, on Friday agreed to cover Amarin’s controversial cholesterol drug Vascepa, amidst turbulence for Amarin.

Amarin and NICE agreed to a price of £144.21 per 120 soft capsules (or $181 for 30-day supply), according to Amarin. Low-price generic versions of Vascepa, known as icosapent ethyl, cost about $100 in the US, according to GoodRx.

It’s clear from #ASCO22 that biopharma audiences are back, live, at the big conferences. That’s encouraging, as we return to more face-to-face meetings to advance the work at hand. But go behind the busy center stage, and you’ll see plenty of worrying signs that biotech — though not Big Pharma — is in for a rough ride. And just when it ends is anyone’s guess right now.

Sentiment is one thing, data another. And there’s no denying that the numbers have changed dramatically. We asked DealForma chief Chris Dokomajilar to crunch the numbers a little bit early for H1, in order to get a look at the trends in play here during a watershed year for the biotech industry.

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Paul Hastings doesn’t offer the usual biotech executive cliches. The ones endorsed by the media consultant crowd. And sometimes the Nkarta CEO doesn’t even wait for a question before jumping straight to his answers, his truth, as he likes to call it. And that was the way we started our conversation about his first year as chair of BIO, and how the next year is shaping up. Hastings will join our panel on managing a biotech during turbulent times, which will be available in a live setting in San Diego, or online. You can register for that — along with a lineup of virtual events — here. — John Carroll

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