Belén Garijo (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA adds 350 work­ers at French site to build ca­pac­i­ty for 's­in­gle-use' tech for Covid-19 vac­cines, ther­a­pies

Ger­many’s Mer­ck KGaA has seen a growth spurt in re­cent months dri­ven by sky-high de­mand for Covid-19 drugs and vac­cines. Now, the com­pa­ny is flesh­ing out a French pro­duc­tion site to pro­duce one-and-done pro­duc­tion tech that can help Covid-19 man­u­fac­tur­ers scale up faster.

Mer­ck KGaA through its Mil­li­pore­Sig­ma sub­sidiary will in­vest near­ly $30 mil­lion and add 350 po­si­tions to its Mol­sheim, France fa­cil­i­ty to build ca­pac­i­ty for “sin­gle-use” tech­nol­o­gy, pre­assem­bled pro­duc­tion equip­ment that al­lows com­pa­nies to rapid­ly scale their own pro­duc­tion, Mer­ck KGaA said this week.

The ex­pan­sion will al­so add 18,300 square feet of man­u­fac­tur­ing space, in­clud­ing ISO7 or ISO5 clean­rooms, us­ing a mod­u­lar de­sign that won’t dis­rupt ex­ist­ing op­er­a­tions, the com­pa­ny said. Mer­ck KGaA ex­pects the new space to go on­line by the end of 2021.

Mer­ck KGaA paint­ed the ex­pan­sion as a move to meet in­creased de­mand for Covid-19 vac­cines and ther­a­peu­tics, where drug­mak­ers in the space have looked to quick­ly scale pro­duc­tion to meet glob­al de­mand. The Mol­sheim site is Mer­ck KGaA’s first EU site to pro­duce sin­gle-use tech, join­ing ex­ist­ing fa­cil­i­ties in WuXi Chi­na, and Dan­vers, MA, where the firm is al­so look­ing to dou­ble ca­pac­i­ty for sin­gle-use prod­ucts.

“In re­cent years, many bio­phar­ma­ceu­ti­cal man­u­fac­tur­ers have turned to sin­gle-use tech­nolo­gies for their flex­i­bil­i­ty, cost sav­ings, speed and re­duced risk, lead­ing to dou­ble-dig­it mar­ket growth for this seg­ment,” Chris Ross, Mer­ck KGaA’s in­ter­im sec­tor head of life sci­ence, said in a state­ment. “The coro­n­avirus pan­dem­ic has ac­cel­er­at­ed this trend, with most pro­grams us­ing sin­gle-use pro­duc­tion tem­plates.”

The Mol­sheim fa­cil­i­ty is the third largest in Mer­ck KGaA’s life sci­ence port­fo­lio, em­ploy­ing more than 1,700 work­ers of 32 dif­fer­ent na­tion­al­i­ties and pro­duc­ing more than 10,000 prod­ucts, the com­pa­ny said. More than 85% of the prod­ucts pro­duced on site are ex­port­ed glob­al­ly.

Once fo­cused on bio­mon­i­tor­ing and wa­ter pu­rifi­ca­tion, Mol­sheim will now see its mis­sion change as Mer­ck KGaA con­tin­ues to rapid­ly ex­pand fol­low­ing a big year for con­tract man­u­fac­tur­ers amid the pan­dem­ic.

In Jan­u­ary, Mer­ck KGaA an­nounced it would ac­quire mR­NA CD­MO AmpTec in Ham­burg, say­ing it plans to strength­en its own ca­pac­i­ties to de­vel­op and man­u­fac­ture mR­NA for cus­tomers to use in “vac­cines, treat­ments and di­ag­nos­tics ap­plic­a­ble in Covid-19 and many oth­er dis­eases.”

Just a month lat­er, the Darm­stadt, Ger­many-based com­pa­ny an­nounced it would boost its pro­duc­tion of lipids used to trans­port mR­NA vac­cines as part of a deal with Pfiz­er and Ger­man neigh­bor BioN­Tech for their Covid-19 shot. Lipid nanopar­ti­cles are a key de­liv­ery tech for mR­NA vac­cines, which re­quire sta­ble en­cap­su­la­tion to trav­el through the blood­stream.

Mer­ck’s ag­gres­sive ex­pan­sion is tak­ing place dur­ing the tran­si­tion in­to pow­er of Belén Gar­i­jo, named CEO in Sep­tem­ber and one of the few fe­male bio­phar­ma lead ex­ec­u­tives. Gar­i­jo is set to re­place long­time leader Ste­fan Os­chmann in May, pick­ing up his role and ex­ec­u­tive chair seat.

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.

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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:

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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.

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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.

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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.

JP Gabriel, Ocugen

JP Gabriel watched from the bleach­ers as the pan­dem­ic raged. Now head of sup­ply chain at Ocu­gen, he's ready to bat

The world was in the middle of the most pressing public health risk his generation had ever seen, and JP Gabriel felt like he was sitting on the sidelines. As a VP of biologics and mRNA manufacturing at Ultragenyx, Gabriel watched from the sidelines as players like Pfizer/BioNTech and Moderna used mRNA tech to chase their own Covid-19 vaccines.

This month, Gabriel got the chance to get his hands dirty against the pandemic — but it won’t be with mRNA.

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