Man­u­fac­tur­ing roundup: As­traZeneca widens part­ner­ship in Abu Dhabi; Mod­er­na fi­nal­izes its part­ner­ship with the UK

UK-based As­traZeneca and Abu Dhabi-based G42 Health­care have inked a strate­gic man­u­fac­tur­ing deal to make drugs in the cap­i­tal of the Unit­ed Arab Emi­rates.

The man­u­fac­tur­ing deal will fo­cus on R&D and “lo­cal­iz­ing” in­dus­tries to pro­duce phar­ma prod­ucts, as As­traZeneca al­so has “on­go­ing ef­forts” with the De­part­ment of Health of Abu Dhabi.

Abu Dhabi has un­veiled plans to dou­ble the size of its man­u­fac­tur­ing sec­tor by 2031, and this deal plays in­to that fore­cast, as both G42 and As­traZeneca col­lab­o­rate to boost ex­ports of drug prod­ucts and col­lab­o­rate on re­search projects.

“We are now tak­ing our com­pre­hen­sive ex­ist­ing part­ner­ship with G42 Health­care to new heights, ac­cel­er­at­ing it across lo­cal man­u­fac­tur­ing, re­search, in­no­va­tion and sus­tain­abil­i­ty,” said Sameh ElFan­gary, the clus­ter pres­i­dent for GCC and Pak­istan at As­traZeneca, in a state­ment.

This is al­so not the first deal be­tween the UK-based phar­ma and G42. The two kicked off with a “de­c­la­ra­tion of col­lab­o­ra­tion” in late 2021, and this past sum­mer, G42 signed a let­ter of in­tent with As­traZeneca to ex­pand col­lab­o­ra­tion in di­ag­nos­tics and clin­i­cal re­search.

While the two par­ties are look­ing to in­crease man­u­fac­tur­ing in Abu Dhabi, they’ve re­mained mum on the de­tails of their deal, and they’ve giv­en no in­di­ca­tion of what is be­ing pro­duced or when man­u­fac­tur­ing is set to be­gin. End­points News reached out to As­traZeneca for fur­ther com­ment but did not re­ceive a re­sponse by press time.

Mod­er­na makes head­way with UK gov­ern­ment deal 

In the sum­mer, Mod­er­na looked to open a large-scale mR­NA man­u­fac­tur­ing cen­ter to pro­duce Covid-19 vac­cines and oth­er vac­cines for flu and RSV, and while the de­tails on where the fa­cil­i­ty will be built are still not con­firmed, the UK gov­ern­ment and the vac­cine mak­er have tak­en a step for­ward in mak­ing that cen­ter a re­al­i­ty, but no de­tails on when or where it will be built have been re­vealed.

How­ev­er, on Thurs­day, Mod­er­na did an­nounce the “fi­nal­iza­tion” of a strate­gic part­ner­ship with the UK gov­ern­ment. Mod­er­na CEO Stephane Ban­cel said in a state­ment that the new fa­cil­i­ty will plan to pro­vide the UK with ac­cess to pan­dem­ic re­sponse ca­pa­bil­i­ties with its Covid-19 vac­cines and “fu­ture res­pi­ra­to­ry virus vac­cine can­di­date” ac­cess.

Once the site, called the Mod­er­na In­no­va­tion and Tech­nol­o­gy Cen­ter, comes on­line, it will plan to pro­vide ac­cess to do­mes­ti­cal­ly-man­u­fac­tured mR­NA vac­cines for res­pi­ra­to­ry virus­es, pend­ing reg­u­la­to­ry ac­tion. Al­so, the MITC will sup­port the UK in glob­al ef­forts to re­duce the im­pact of fu­ture pan­demics.

Once op­er­a­tional, the Mod­er­na In­no­va­tion and Tech­nol­o­gy Cen­tre (MITC) is in­tend­ed to pro­vide ac­cess to a do­mes­ti­cal­ly man­u­fac­tured port­fo­lio of fu­ture mR­NA vac­cines against res­pi­ra­to­ry virus­es, pend­ing reg­u­la­to­ry as­sess­ment and li­cen­sure. In ad­di­tion, the fa­cil­i­ty is in­tend­ed to pro­vide the UK with di­rect ac­cess to pan­dem­ic re­sponse ca­pa­bil­i­ties, which will sup­port the UK in its glob­al ef­forts as part of its “100 Days Mis­sion” to re­duce the im­pact of fu­ture pan­demics. As part of the ten-year part­ner­ship, Mod­er­na will al­so sup­port the UK’s mR­NA health and sci­ence ecosys­tem.

“When con­struct­ed, our fa­cil­i­ty will har­ness mR­NA sci­ence with the aim of de­vel­op­ing and man­u­fac­tur­ing vac­cines that have the po­ten­tial to ad­dress fu­ture threats posed by res­pi­ra­to­ry virus­es.” said Dar­ius Hugh­es, gen­er­al man­ag­er at Mod­er­na for the UK, in a state­ment.

BioN­Tech’s man­u­fac­tur­ing fa­cil­i­ty in Rwan­da read­ies for kick-off

BioN­Tech’s ef­forts to have a man­u­fac­tur­ing fa­cil­i­ty in Africa for mR­NA are now tak­ing a clos­er step to re­al­i­ty.

The six ship­ping con­tain­ers, dubbed BioN­Tain­ers, for its man­u­fac­tur­ing fa­cil­i­ty in the Rwan­dan cap­i­tal of Ki­gali, have fin­ished con­struc­tion in Eu­rope and have un­der­gone qual­i­ty checks by BioN­Tech. The com­pa­ny said that the con­tain­ers are now be­ing pre­pared for ship­ment to Ki­gali and are ex­pect­ed to ar­rive some­time in the first quar­ter of 2023.

Mean­while, BioN­Tech is con­tin­u­ing the de­vel­op­ment and the build of the man­u­fac­tur­ing fa­cil­i­ty it­self in Ki­gali, which will house the BioN­Tain­ers, and will be a part of a de­cen­tral­ized man­u­fac­tur­ing net­work in the African con­ti­nent. BioN­Tech is plan­ning to ship the con­tain­ers to Sene­gal and po­ten­tial­ly South Africa. The vac­cines that are pro­duced in BioN­Tech’s African net­work will be ded­i­cat­ed to pa­tients liv­ing in African Union mem­ber states.

In­vest­ment firm KKR snaps up Japan­ese CD­MO

The in­vest­ment firm KKR has inked an agree­ment to ac­quire all the shares of the Japan­ese-based CD­MO Bushu Phar­ma from BPEA EQT.

Bushu man­u­fac­tures prod­ucts such as oral med­i­cines and in­jecta­bles as well as clin­i­cal tri­al ma­te­ri­als for the glob­al mar­ket but has a fo­cus on Japan and oth­er na­tions in Asia, in­clud­ing Chi­na. KKR plans to work with Bushu’s man­age­ment to ex­pand its of­fer­ings in in­jecta­bles as well as in­vest in “ca­pac­i­ty ex­pan­sion” and qual­i­ty con­trol.

The deal is ex­pect­ed to close in the first quar­ter of 2023.

“We see sig­nif­i­cant de­mand for strate­gic and re­li­able so­lu­tions to ad­dress a range of chal­lenges fac­ing the glob­al health­care in­dus­try. By lever­ag­ing KKR’s deep ex­pe­ri­ence in health­care, tech, and sup­ply chain so­lu­tions, we aim to help Bushu Phar­ma to fur­ther scale its best-in-class busi­ness and to dri­ve growth and tech­ni­cal in­no­va­tion that will ul­ti­mate­ly ben­e­fit pa­tients in Japan and around the world,” said Hi­ro Hi­ra­no, the CEO of KKR Japan in a state­ment.

Alvotech hand­ed a new date for FDA de­ci­sion on Hu­mi­ra biosim­i­lar

The Ice­landic biosim­i­lar pro­duc­er Alvotech has been grant­ed a new Biosim­i­lar User Fee Amend­ment (Bs­U­FA) goal date, set for April 13 of next year, for its orig­i­nal BLA for AVT02 as a biosim­i­lar for Hu­mi­ra.

The ap­proval of the ap­pli­ca­tion will re­quire the “sat­is­fac­to­ry” re­sult of a rein­spec­tion of its fa­cil­i­ty in Reyk­javik, Ice­land. Alvotech said in its an­nounce­ment it is work­ing with the FDA to sched­ule the in­spec­tion for the first quar­ter of the new year. The key re­quire­ment for ap­proval, ac­cord­ing to Alvotech, is the same as for the orig­i­nal BLA, which is hav­ing a sat­is­fac­to­ry out­come of the rein­spec­tion of the fa­cil­i­ty.

Mean­while, in a state­ment, Alvotech Founder Robert Wess­man is re­main­ing con­fi­dent about the an­tic­i­pat­ed launch of AVT02 in the US on Ju­ly 1 of next year.

 KBI nets a li­cense from Swiss reg­u­la­tors for its ex­pand­ed fa­cil­i­ty in Gene­va

KBI Bio­phar­ma has been giv­en a reg­u­la­to­ry es­tab­lish­ment li­cense from Swissmedic, the na­tion’s au­thor­i­ty for med­i­cines, for its ex­pand­ed mam­malian cell man­u­fac­tur­ing fa­cil­i­ty in Gene­va.

The des­ig­na­tion, ac­cord­ing to KBI, shows that the ex­pan­sion com­plies with cGMP stan­dards. The thumbs up from the Swiss reg­u­la­tors al­so come af­ter the fa­cil­i­ty was ex­pand­ed in Ju­ly of 2022. The ex­pand­ed 8,733 square foot ex­pan­sion in­cludes a new man­u­fac­tur­ing line for cells as well as ac­com­mo­dat­ing its CD­MO ser­vices.

“It’s crit­i­cal for our drug de­vel­op­ment clients mov­ing in­to phase one and phase two clin­i­cal tri­als to con­fi­dent­ly part­ner with trust­ed cGMP-cer­ti­fied man­u­fac­tur­ers for their growth and fu­ture suc­cess. This li­cense is a crit­i­cal com­po­nent of KBI’s stream­lined and cost-ef­fec­tive so­lu­tions to help world­wide biotech­nol­o­gy com­pa­nies op­ti­mize their process­es and ad­vance their in­no­v­a­tive ther­a­pies,” said KBI COO Mike Lan­dau, in a state­ment.

Asym­chem opens the doors to a new R&D fa­cil­i­ty in Mass­a­chu­setts

The Chi­nese CD­MO Asym­chem has opened a new fa­cil­i­ty in the Boston sub­urb of Woburn, Mass­a­chu­setts.

The new site will be cen­tered on pro­vid­ing “ear­ly-stage” re­search and de­vel­op­ment ser­vices such as chem­i­cal process de­vel­op­ment, and the de­vel­op­ment of small mol­e­cules, pep­tides and oligonu­cleotides, among oth­er ser­vices.

Asym­chem’s new site has 6,000 square feet of lab space and can ex­pand in­to an ad­di­tion­al 4,500 square feet of space. Some labs will be on­line in the first quar­ter of 2023, but oth­ers won’t be ready un­til the third quar­ter.

“Asym­chem has been work­ing dili­gent­ly in re­cent years to bring biotech clients an even more well-round­ed CMC ex­pe­ri­ence when man­ag­ing ear­ly-stage projects. The com­pa­ny’s ex­pan­sion to Boston has be­come an in­te­gral part of this jour­ney to bet­ter serve Asym­chem’s na­tion­al and glob­al part­ners.” Said Hao Hong, the CEO of Asym­chem Group, in a state­ment.

For­mu­lat­ed So­lu­tions ac­quires site in Ten­nessee for drug pro­duc­tion

The Flori­da-based con­tract man­u­fac­tur­er For­mu­lat­ed So­lu­tions has ac­quired a 43-year-old 455,000-square-foot site in Cleve­land, TN, and is ap­proved by the FDA.

The site, once the deal is com­plet­ed, will man­u­fac­ture nasal sprays, and, ac­cord­ing to For­mu­lat­ed So­lu­tions, the site has “ex­ten­sive” pro­duc­tion and pack­ag­ing ca­pa­bil­i­ties. The two-build­ing site sits on 60 acres and has had sev­er­al im­prove­ments over the years to be able to ful­fill sev­er­al man­u­fac­tur­ing needs.

No de­tails were giv­en on the cost of the site or the head­count at the fa­cil­i­ty.  The com­pa­ny cur­rent­ly has a 220,000-square-foot man­u­fac­tur­ing site in cen­tral Flori­da.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

UK gov­ern­ment, pri­vate in­vestors dole out $340M+ to drug, di­ag­nos­tic man­u­fac­tur­ers

The government of the United Kingdom is giving out grants to several manufacturers that have a presence in England, Wales and Northern Ireland.

The government announced that four companies, including Ipsen, contract manufacturer Pharmaron, DNA manufacturer Touchlight and diagnostic test producer Randox, will receive a total of £277 million ($341.1 million). According to a release from the UK government, this represents the first portion of grants from the Life Sciences Innovative Manufacturing Fund.

Phar­maron ex­pand­ing Liv­er­pool man­u­fac­tur­ing fa­cil­i­ty with a $186M+ price tag

Liverpool may be known for rock and roll and premier league football, but the China-based contract manufacturer Pharmaron is looking to make it a bigger hub for cell and gene therapy manufacturing.

As part of Pharmaron’s further commitment to Merseyside county, it plans to build an 8,000-square-meter facility, or around 86,000 square feet, which includes a boost to the manufacturing capacity of 3,500 square meters, or 37,600 square feet. The price tag for the expansion will be £151 million ($186 million), with Pharmaron receiving a grant from the UK Government’s Life Sciences Innovation Manufacturing Fund (LSIMF).

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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