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.