Man­u­fac­tur­ing roundup: Ace­to re­brands to Actylis; WuXi STA opens an­oth­er fa­cil­i­ty

A New York-based man­u­fac­tur­er has re­brand­ed af­ter net­ting sev­er­al ac­qui­si­tions in the past few years.

Ace­to, a man­u­fac­tur­er of in­gre­di­ents and raw ma­te­ri­als, has re­brand­ed to Actylis. The move will bring all 10 ac­qui­si­tions the com­pa­ny has made in the past sev­er­al years un­der one ban­ner.

“Actylis unites mul­ti­ple in­dus­try spe­cial­ists with a wide range of ca­pa­bil­i­ties in­to a new, glob­al en­ter­prise with a unique hy­brid ap­proach that is greater than the sum of its parts. This con­sol­i­da­tion en­ables us to of­fer cus­tomers across di­verse lo­ca­tions and in­dus­tries high­ly flex­i­ble, cus­tomized so­lu­tions ad­dress­ing their spe­cif­ic needs while as­sur­ing re­li­able on-time de­liv­ery of the high-qual­i­ty in­gre­di­ents es­sen­tial to their suc­cess,” said CEO Gilles Cot­ti­er in a state­ment.

With all the com­pa­nies now un­der one name, the com­pa­ny now boasts a head­count of over 850 staff with a pres­ence in 10 coun­tries.

The com­pa­ny ac­quired Irish com­pa­ny A&C Bio Buffer last year to help bol­ster its Covid-19 re­lief ef­forts and ex­pand its man­u­fac­tur­ing ca­pa­bil­i­ties.

WuXi STA con­tin­ues its ex­pan­sion dri­ve with the open­ing of an oral drug man­u­fac­tur­ing site

WuXi STA is keep­ing up its mo­men­tum by open­ing an­oth­er site in its man­u­fac­tur­ing chain.

The com­pa­ny an­nounced it has opened its high po­ten­cy oral drug prod­uct man­u­fac­tur­ing site at its cam­pus in Wuxi, Chi­na. Ac­cord­ing to the com­pa­ny, this move al­lows it to man­u­fac­ture high-po­ten­cy drug can­di­dates as well as build out its ca­pac­i­ty for more drug pro­duc­tion.

The fa­cil­i­ty can cov­er a wide range of ser­vices in­clud­ing wet and dry gran­u­la­tion, tablet com­pres­sion and coat­ing and cap­sule fill­ing. WuXi STA ex­pects the fa­cil­i­ty to man­u­fac­ture 400 mil­lion ta­bles and 200 mil­lion cap­sules an­nu­al­ly.

The fa­cil­i­ty will al­so al­low it to pro­vide a net­work for R&D ser­vices and man­u­fac­tur­ing of high po­ten­cy ac­tive phar­ma­ceu­ti­cal in­gre­di­ents in­to com­mer­cial prod­ucts. The com­pa­ny is al­so plan­ning to open an­oth­er high po­ten­cy parental pro­duc­tion plant at the WuXi cam­pus in Q3 of next year.

“As our glob­al part­ners and cus­tomers seek ac­cel­er­at­ed path­ways for new drug de­vel­op­ment, WuXi STA is com­mit­ted to fur­ther en­hanc­ing our in­te­grat­ed plat­form to en­able more health­care break­throughs that ben­e­fit pa­tients world­wide,” said WuXi STA CEO Mingzhang Chen, in a state­ment.

WuXi STA’s re­cent ex­pan­sion projects in­clude the build­ing of a 190-acre man­u­fac­tur­ing cam­pus in Mid­dle­town, DE, along with the open­ing of sev­er­al oth­er pro­duc­tion fa­cil­i­ties in Chi­na.

Chi­nese CD­MO plans for a build­ing project in Jiang­su Province

Asym­chem, a CD­MO that has a pres­ence on three con­ti­nents, is look­ing much clos­er to home for its next project.

Ac­cord­ing to a doc­u­ment sub­mit­ted to the Hong Kong Stock Ex­change, Asym­chem it is plan­ning to con­struct a site at the Jiang­su Taix­ing Eco­nom­ic De­vel­op­ment Zone, a de­vel­op­ment area along the banks of the Yangtze Riv­er out­side of Shang­hai.

The site will even­tu­al­ly house R&D op­er­a­tions as well as the man­u­fac­tur­ing of chem­i­cals and small mol­e­cule drug prod­ucts. The to­tal in­vest­ment that is planned for the site is planned to be with­in the range of RMB4,000,000,000 to RMB5,000,000,000 ($559.8 mil­lion to $669.77 mil­lion).

Asym­chem plans to fund the project with its cash or by “self-rais­ing funds”, but no de­tails have been re­leased. De­tails on size, em­ploy­ee count, or when con­struc­tion will start have al­so not been re­leased.

Nu­cle­us Bi­o­log­ics pulls back the cur­tain on new San Diego cell cul­ture man­u­fac­tur­ing site

A San Diego cell cul­ture pro­duc­er has opened a new fa­cil­i­ty.

Nu­cle­us Bi­o­log­ics, a provider of cell cul­ture me­dia prod­ucts, has cut the rib­bon on its newest fa­cil­i­ty. The com­pa­ny’s new 19,884-square-foot fa­cil­i­ty has two pow­der and four liq­uid clean­rooms to boost cell cul­ture man­u­fac­tur­ing.

Nu­cle­us said that it can in­crease its pro­duc­tion to 2.5 mil­lion liters of prod­uct per year.

“We have seen rapid growth in both the cell and gene ther­a­py in­dus­try and our busi­ness and are ex­pand­ing man­u­fac­tur­ing and clean­room ca­pac­i­ty to sup­port our ther­a­py cus­tomers to speed the time from dis­cov­ery to cure,” said David Shee­han CEO of Nu­cle­us Bi­o­log­ics, in a state­ment.

The move is one of the lat­est for the com­pa­ny as it has ex­pand­ed to 70 staff mem­bers and has net­ted deals with Cy­ti­va and with one of its spin­offs Sto­ic Bio.

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Tim Van Hauwermeiren, argenx CEO

Ar­genx pur­chas­es $100M+ FDA pri­or­i­ty re­view vouch­er from blue­bird bio

Argenx’s Vyvgart is due for a speedy review at the FDA, thanks to a $102 million priority review voucher (PRV).

The Netherland-based biotech picked up the PRV from bluebird bio, the companies announced on Wednesday. PRVs shorten a drug’s FDA review period from 10 months to 6 months, though they often sell on the open market for around $100 million each.

Argenx plans on using the express ticket on efgartigimod, its neonatal Fc receptor (FcRn) blocker marketed as Vyvgart for adults with generalized myasthenia gravis (gMG). While Vyvgart won its first approval last December for the chronic neuromuscular disease — which is characterized by difficulties with facial expression, speech, swallowing and breathing — CEO Tim Van Hauwermeiren said in a news release that he plans to “be active in fifteen disease targets by 2025.”

Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Emily Leproust, Twist Bioscience CEO

Twist Bio­science’s 'fac­to­ry of the fu­ture' in Ore­gon could de­liv­er with com­pet­i­tive pric­ing, SVB Se­cu­ri­ties says

The synthetic DNA manufacturer Twist Bioscience has given a peek behind the curtain to several analysts into its “factory of the future” as well as insight into the cost structure, workflow and technology at the site.

The 110,000-square-foot manufacturing site in the city of Wilsonville, OR, just south of Portland, which was announced back in 2020, will double Twist’s production capacity and bring around 400 jobs to the area.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Lil­ly's Covid-19 mAb no longer au­tho­rized due to Omi­cron sub­vari­ants, FDA says

The FDA on Wednesday announced that Eli Lilly’s Covid-19 drug bebtelovimab is no longer authorized to treat Covid-19 because of the rising numbers of two new subvariants that the drug does not work against.

The Centers for Disease Control and Prevention last week published new estimates that the combined proportion of Covid-19 cases caused by the Omicron subvariants BQ.1 and BQ.1.1 are greater than 57% nationally, and already above 50% in all individual regions but one.

Digital render of CPI's Medicines Manufacturing Innovation Centre in Glasgow, Scotland (Image: uk-cpi.com)

CPI opens the doors to a new $100M+ man­u­fac­tur­ing fa­cil­i­ty in Scot­land

A manufacturing site that has received interest and investments from large pharma companies and the UK government is opening its doors in Scotland.

The manufacturer CPI (Centre for Process Innovation) has opened a new £88 million ($105 million) “Medicines Manufacturing Innovation Centre” in Glasgow, Scotland, to accelerate the development of manufacturing tech and solve longstanding challenges in medicine development and manufacturing.

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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