Novartis' manufacturing hub in Stein, Switzerland (Novartis)

UP­DAT­ED: Swiss CD­MO Celonic finds a home at No­var­tis' Stein hub, plans to add 250 new jobs cen­tered on next-gen drugs

The out­sourc­ing mar­ket for cell and gene ther­a­pies has stayed red-hot in re­cent months as some of the biggest CD­MOs — and even ma­jor drug­mak­ers — are div­ing in. Now, a Swiss CD­MO wants a big­ger piece of the ac­tion, and it’s look­ing to set up shop in No­var­tis’ fledg­ling life sci­ences hub in Stein.

Celonic plans to build a 91,500-square-foot man­u­fac­tur­ing cen­ter fo­cused on cell and gene ther­a­pies, next-gen vac­cines and oth­er “in­no­v­a­tive” drugs as part of a two-part ex­pan­sion at No­var­tis’ Rhine Val­ley hub, the CD­MO said last week.

The ex­pan­sion will add rough­ly 250 work­ers at the site, Celonic said, as well as up to 20 man­u­fac­tur­ing clean rooms, and lab and of­fice space. The fa­cil­i­ty is set to open in Q2 2022, Celonic said.

Celonic makes the third drug­mak­er to call No­var­tis’ Life Sci­ence Park Rhein­tal in Stein — for­mer­ly just a pro­duc­tion site — home. The area cur­rent­ly hosts both No­var­tis and Lon­za, Celonic said, with as many as 2,000 em­ploy­ees work­ing there.

In news that didn’t make much of a wave state­side, No­var­tis an­nounced in mid-Feb­ru­ary that it planned to shift its Stein lo­ca­tion in­to a life sci­ences hub as part of an ef­fort to drum up in­vest­ment in the Rhine Val­ley and es­tab­lish a cen­ter of pro­duc­tion for cell and gene ther­a­pies. No­var­tis it­self has in­vest­ed around $217 mil­lion in ex­pan­sions in Stein and Schweiz­er­halle in 2020 and 2021, adding to its own foot­print in the re­gion.

A No­var­tis spokesper­son said the firm was on the hunt for oth­er com­pa­nies to jump on board.

“We are ba­si­cal­ly open to all types of com­pa­nies for well-known large com­pa­nies as well as for small or medi­um-sized start-ups,” the spokesper­son told End­points News. “We are cur­rent­ly in talks with po­ten­tial part­ners whether there is in­ter­est in mov­ing to Stein and ben­e­fit­ing from our wide range of ser­vices. It is im­por­tant to know that this is a process that will take place over the next few years and that the change will be grad­ual.”

Of course, cell and gene ther­a­pies are not a new tar­get of in­vest­ment in the con­tract man­u­fac­tur­ing space, with some of the biggest CD­MOs mak­ing mas­sive down pay­ments on the tricky-to-make ther­a­peu­tics.

Late last month, out­sourc­ing gi­ant Catal­ent dove even fur­ther in­to the field with its ac­qui­si­tion of plas­mid DNA spe­cial­ist Del­phi Ge­net­ics and the launch of man­u­fac­tur­ing ser­vices in that space at its Rockville, MD fa­cil­i­ty. Del­phi, found­ed in 2001 and head­quar­tered near Catal­ent’s fa­cil­i­ty in Gos­selies, Bel­gium, will add a 17,000 square-foot fa­cil­i­ty to the Catal­ent fold spe­cial­iz­ing in all stages of clin­i­cal plas­mid sup­ply.

Back in Feb­ru­ary 2020, Catal­ent shelled out $315 mil­lion for cell ther­a­py spe­cial­ist MaS­Ther­Cell Glob­al and its 32,000 square-foot fa­cil­i­ty in Hous­ton along with a 25,000 square-foot fa­cil­i­ty in Gos­selies. MaS­Ther­Cell al­so plot­ted a 60,000 square-foot ad­di­tion in Bel­gium that’s set to open in fall 2021.

In Oc­to­ber of last year, Catal­ent ac­quired an­oth­er Gos­selies cell and gene ther­a­py play­er, Bone Ther­a­peu­tics, and its 31,000-square-foot site for a mea­ger $14 mil­lion. A month ear­li­er, Catal­ent out­lined its plans to in­fuse $130 mil­lion in­to its cell and gene ther­a­py man­u­fac­tur­ing fa­cil­i­ty in Har­mans, MD, specif­i­cal­ly tar­get­ing late clin­i­cal-stage sup­ply.

Mean­while, even the big drug­mak­ers are writ­ing checks to dou­ble down in the space. In Feb­ru­ary, Bris­tol My­ers Squibb said it will add a 244,000 square-foot cell ther­a­py man­u­fac­tur­ing fa­cil­i­ty at its De­vens, MA site as it looks to grow its pro­duc­tion ca­pac­i­ty around new­ly ap­proved liso-cel and, po­ten­tial­ly, ide-cel in the com­ing weeks.

The 89-acre De­vens site in the Boston area will hold the fourth in-house cell ther­a­py man­u­fac­tur­ing site for Bris­tol, along­side fa­cil­i­ties in Both­ell, WA; and War­ren and Sum­mit, NJ. Bris­tol al­so counts con­tract part­ners in the EU and Japan as part of its cell ther­a­py net­work.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

Endpoints Premium

Premium subscription required

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

Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

Endpoints Premium

Premium subscription required

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

Werner Lanthaler, Evotec CEO

Evotec strength­ens its French con­nec­tion, pledg­ing to drop $120M in­to Toulouse plant for Covid-19 an­ti­bod­ies

Much of the recent focus on manufacturing capacity for Covid-19 has been on vaccines, and for good reason, too. But countries are also hoping to build a big enough footprint to produce pandemic-level monoclonal antibodies, and now France is working with Germany’s Evotec to stay prepared.

Evotec will lay out $120 million with a $60 million boost from multiple French governments and investors to build a new biologics facility in Toulouse that will expand its capacity to produce therapeutic antibodies for Covid-19, the German CDMO and biotech said this week.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 107,500+ biopharma pros reading Endpoints daily — and it's free.

Why re­mote drug man­u­fac­tur­ing eval­u­a­tions won't re­al­ly re­duce FDA's back­log of in­spec­tions

For the first several months of the pandemic last spring, the FDA continued to plow through its user fee-enabled work on new drug and biologic applications, meeting nearly all of its goal dates.

But by last fall and into the winter, complete response letters and other delays began arriving in companies’ mailboxes as the agency struggled to catch up to a growing backlog of both domestic and foreign drug manufacturing inspections.

Endpoints Premium

Premium subscription required

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

From left: James Brown, Michael Chambers, John Ballantyne

Alde­vron founders back a biotech start­up that's look­ing to end the moral de­bate over cell lines once and for all

For millions of Catholics around the world, the development of new vaccines to combat Covid-19 has sparked a moral dilemma. All the approved vaccines in use relied — in some fashion — on cell lines that were derived from aborted fetal tissue.

While church leaders accepted the vaccines and recommended their use to end the pandemic, a number also highlighted their preference for the mRNA vaccines from Pfizer/BioNTech and Moderna over the J&J and AstraZeneca shots, which they noted were more heavily dependent on cell lines that they found morally objectionable.

House Committee on Oversight and Reform Chairwoman Carolyn Maloney (Getty Images)

House De­moc­rats call on Emer­gent ex­ecs to tes­ti­fy on qual­i­ty is­sues next month

The House Oversight Committee is investigating Covid-19 vaccine producer Emergent BioSolutions, which secured a $628 million US government contract to make AstraZeneca and J&J vaccines despite “a long, documented history” of quality control issues, Democrats said in a letter to the contract manufacturer’s executives.

Emergent’s Baltimore plant, which was shuttered on Monday by FDA, has been embroiled in controversy after being forced to destroy millions of AstraZeneca and J&J doses due to an ingredient mix-up and possible contamination.