A rendering of Thermo Fisher's new standalone, 130,000 square-foot facility to be built in Greenville, NC (Thermo Fisher)

Look­ing for an edge in vac­cines, Ther­mo Fish­er plots ma­jor ex­pan­sions across glob­al man­u­fac­tur­ing sites in its port­fo­lio

In a big year for con­tract man­u­fac­tur­ers, Mass­a­chu­setts’ Ther­mo Fish­er Sci­en­tif­ic has emerged as a lead­ing part­ner for drug­mak­ers fight­ing the Covid-19 pan­dem­ic, par­tic­u­lar­ly in di­ag­nos­tics and ther­a­peu­tics. Now, buoyed by that suc­cess and look­ing to scale up its vac­cine of­fer­ings, Ther­mo Fish­er is plot­ting big ex­pan­sion across its glob­al port­fo­lio.

Ther­mo Fish­er will ex­pand its fa­cil­i­ties in Greenville, NC; Fer­enti­no and Mon­za, Italy; and Swin­don, Eng­land, to ex­pand its range of of­fer­ings for cus­tomers”whether it’s an emerg­ing biotech work­ing on a vac­cine for a nov­el virus or a high-vol­ume phar­ma­ceu­ti­cal man­u­fac­tur­er de­liv­er­ing nec­es­sary med­i­cines at scale,” a spokesper­son told End­points News.

Ther­mo is keep­ing the cap­i­tal out­lay for the projects un­der wraps, but here’s more about each site’s ex­pan­sion:

Greenville, NC: A new, stand­alone 130,000-square-foot build­ing which com­pris­es two live-virus fill­ing lines (op­er­a­tional in 2022), and sev­en oth­er new lines in­clud­ing com­mer­cial-scale liq­uid fill­ing lines and a de­vel­op­ment line for liq­uid and lyophilized drug prod­ucts and sy­ringes (op­er­a­tional in 2021).

Fer­enti­no, Italy: A 28,000-square-foot de­vel­op­ment build­ing will of­fer new ca­pac­i­ty for one flex­i­ble line of de­vel­op­ment projects and small-scale com­mer­cial man­u­fac­tur­ing (op­er­a­tional in 2022), with the space to add fu­ture ca­pa­bil­i­ties. The site will al­so add on a new high-ca­pac­i­ty com­mer­cial liq­uid fill­ing line that will be op­er­a­tional in 2021.

Mon­za, Italy: This site will ex­pand its ster­ile fill-fin­ish line ca­pac­i­ty, with three new lines ex­pect­ed to be op­er­a­tional in 2021, in­clud­ing one high-ca­pac­i­ty line for liq­uid and lyophilized fill­ing, one pre-filled sy­ringe/pre-filled car­tridge line for medi­um batch pro­duc­tion and one flex­i­ble mul­ti-pur­pose line for low vol­ume fill­ing of vials, pre-filled sy­ringes and pre-filled car­tridges in nest and tub con­fig­u­ra­tions.

Swin­don, Eng­land: The Swin­don ex­pan­sion will ac­tu­al­ly re­vamp the ex­ist­ing 30,000-square-foot site in­to a new, full-scale com­mer­cial man­u­fac­tur­ing fa­cil­i­ty, the spokesper­son said. The site, which will be op­er­a­tional in 2021, will add one pro­duc­tion line for liq­uid and one line for lyophilized — in ad­di­tion to “ex­ten­sive” cold-chain stor­age for vac­cines that re­quire ul­tra-low tem­per­a­tures.

The ex­pan­sions make clear the ever-grow­ing need for vi­able and ster­ile vac­cine pro­duc­tion, even out­side of the cur­rent break­neck ef­forts to pro­duce a Covid-19 vac­cine. Ther­mo Fish­er has wad­ed in­to that race as well, agree­ing in Sep­tem­ber to pro­duce In­ovio’s Covid-19 vac­cine (INO-4800) be­gin­ning in 2021.

Al­so on the Covid-19 front, Ther­mo Fish­er in May en­tered in­to a deal with Cal­i­for­nia-based Hu­mani­gen to help scale up man­u­fac­tur­ing of the biotech’s lenl­izum­ab, a clin­i­cal-stage can­di­date for cy­tokine storms that the com­pa­ny is test­ing in pa­tients with more se­vere cas­es of the res­pi­ra­to­ry virus. In Sep­tem­ber, Ther­mo Fish­er agreed to a deal with the US gov­ern­ment to pro­duce the vi­ral trans­port me­dia tubes need­ed to trans­port Covid-19 test sam­ples.

Pri­or to the four ex­pan­sion sites an­nounced this week, the com­pa­ny al­so an­nounced re­cent­ly an ex­pan­sion in Sin­ga­pore that in­cludes a high-speed ster­ile line for live-virus fill­ing. Ther­mo Fish­er al­so agreed to a joint ven­ture with In­no­force to build a new phar­ma­ceu­ti­cal ser­vices fa­cil­i­ty in Hangzhou, Chi­na that fo­cus­es on in­te­grat­ed bi­o­log­ics drug sub­stance and ster­ile drug prod­uct de­vel­op­ment and man­u­fac­tur­ing.

Both of those sites are ex­pect­ed to be com­plet­ed in 2022.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Covid-19 roundup: Mod­er­na dou­bles down on Covid-19 with new boost­er tri­als; Aus­tralia plans do­mes­tic pro­duc­tion of As­traZeneca vac­cine amid dis­tri­b­u­tion lag

As Merck bows out of the global race to develop vaccines for Covid-19, Moderna is doubling down to make sure they can quell new variants that have recently emerged and quickly spread.

The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

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News brief­ing: Jef­frey Lei­den to chair Tmu­ni­ty board of di­rec­tors; Op­di­vo wins new ap­proval in ad­vanced RCC

Longtime Vertex CEO Jeffrey Leiden is taking on a new role.

Leiden has been appointed chairman of Tmunity’s board of directors, the company announced Monday. The move comes about a year and a half after Leiden announced he’d be stepping down from his position at Vertex.

Vertex saw immense growth under Leiden, leading the company from its exit out of hepatitis C, when cures were moving in, and into cystic fibrosis. The company’s cystic fibrosis triple combo therapy Trikafta is already its best-seller, reaching the distinction just six weeks after launch and recording the strongest first quarter of sales for any drug, per some estimates.

Ron Cooper, Albireo CEO

Al­bireo just ad­vanced down to the 10-yard line at the FDA. And Ron Coop­er’s team is get­ting prepped for the next big play

When Albireo Pharma’s board $ALBO moved to bring in Ron Cooper as the CEO more than 5 years ago, the development-stage company went with an experienced commercial player who had a big-time position on his resume after running Bristol Myers’ commercial ops in Europe.

Now, after successfully navigating a pivotal study, putting them in a foot race with a rival toward an FDA OK, Cooper is getting a boost from regulators on the last drive back to an arena he understands completely.

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