Con­tract man­u­fac­tur­ing com­pa­ny Catal­ent is cut­ting around 600 jobs in Mary­land, Texas, and a ma­jor man­u­fac­tur­ing fa­cil­i­ty in Bloom­ing­ton, IN.

Ac­cord­ing to a re­port from a lo­cal news site, The Bloom­ing­ton­ian, the man­u­fac­tur­er an­nounced in an email sent out to em­ploy­ees that it will be cut­ting 400 po­si­tions at the In­di­ana fa­cil­i­ty. The com­pa­ny will al­so cut 77 jobs by Jan. 15 of next year at a cell ther­a­py fa­cil­i­ty in Web­ster, TX, just out­side of Hous­ton. In Mary­land, the com­pa­ny is re­duc­ing staff at two lo­ca­tions, with 82 jobs be­ing elim­i­nat­ed at Catal­ent’s fa­cil­i­ty in Gaithers­burg, and 53 in Rockville. The lay­offs go in­to ef­fect at those lo­ca­tions on Jan. 14.

In a state­ment, Catal­ent said it had in­creased its ca­pac­i­ties dur­ing the Covid-19 pan­dem­ic and was now rolling back some of that ex­pan­sion.

A Catal­ent al­so spokesper­son told End­points News:

The com­pa­ny said it will of­fer "sev­er­ance and job tran­si­tion sup­port" to af­fect­ed work­ers as well as try to de­ploy as many as pos­si­ble to oth­er open roles in Catal­en­t's net­work, in Bloom­ing­ton's case.

Covid-19 trail­blaz­er Pfiz­er has con­firmed its com­mit­ment to a large ex­pan­sion project on the Emer­ald Isle.

The New York-based com­pa­ny an­nounced on Thurs­day that it will make a €1.2 bil­lion ($1.26 bil­lion) cap­i­tal in­vest­ment in­to its man­u­fac­tur­ing site at Grange Cas­tle in Dublin.

The ex­pan­sion of the site marks Pfiz­er’s largest ex­pan­sion in­vest­ment in Ire­land to date. The ex­pan­sion in­cludes the con­struc­tion of a new fa­cil­i­ty on the premis­es as well as adding in more lab­o­ra­to­ry space and will ul­ti­mate­ly dou­ble the ca­pac­i­ty for “bi­o­log­i­cal drug sub­stance man­u­fac­tur­ing” in the on­col­o­gy and rare dis­ease space as well as in­flam­ma­tion, im­munol­o­gy and in­ter­nal med­i­cines.

The project is cur­rent­ly in the “pre­lim­i­nary de­sign phase,” and con­struc­tion is slat­ed to start in 2024, with com­ple­tion com­ing in 2027. Pfiz­er an­tic­i­pates around 400-500 em­ploy­ee roles will be added, bring­ing its to­tal num­ber of em­ploy­ees in the coun­try to around 5,500.

This is not the first move that Pfiz­er has made at Grange Cas­tle as last year it in­vest­ed €40 mil­lion ($42.1 mil­lion) in­to the site to bring it in­to Pfiz­er's Covid-19 man­u­fac­tur­ing net­work, adding around 75 jobs as well. The site, along with three oth­er man­u­fac­tur­ing fa­cil­i­ties in Ire­land, cur­rent­ly pro­duces med­i­cines and vac­cines for arthri­tis, in­flam­ma­tion, pain, can­cer and an­ti-in­fec­tives, among oth­ers.

Mike Mc­Der­mott, the chief glob­al sup­ply of­fi­cer at Pfiz­er, said in a state­ment:

With the US star­ing down sev­er­al drug short­ages this year, one in par­tic­u­lar is now catch­ing law­mak­er­s' at­ten­tion.

A bi­par­ti­san group of sen­a­tors sent a let­ter to HHS Sec­re­tary Xavier Be­cer­ra and FDA com­mis­sion­er Robert Califf ex­press­ng “strong con­cern” about the amox­i­cillin short­age for pa­tients and gen­er­al pub­lic health. Sens. Amy Klobuchar (D-MN), Sher­rod Brown (D-OH), Ed Markey (D-MA) and Bill Cas­sidy (R-LA) are push­ing for FDA and HHS to start work­ing more force­ful­ly to ad­dress the amox­i­cillin short­age along with the oth­er drug short­ages.

The let­ter says, in part:

The let­ter not­ed that amox­i­cillin, of­ten used to treat pe­di­atric ill­ness­es, is in short sup­ply due to a “record high lev­el of res­pi­ra­to­ry ill­ness­es” that spiked de­mand for it and oth­er med­i­cines, lead­ing to de­lays in care.

Erin Fox, the se­nior phar­ma­cy di­rec­tor at the Uni­ver­si­ty of Utah Health, not­ed that while sen­a­tors such as Klobuchar have been vo­cal about drug short­ages for years, the sit­u­a­tion is not cut and dried.

“FDA can’t make any drug com­pa­ny make any drug no mat­ter how crit­i­cal or life-sav­ing. This is re­al­ly up to the gener­ic drug mak­ers to make these prod­ucts. Most of the com­pa­nies refuse to pro­vide a re­al rea­son for what is go­ing on - and they don’t have to do so pub­licly,” Fox told End­points News via email.

The CD­MO Catal­ent will have to fix is­sues at two man­u­fac­tur­ing plants in the US and Eu­rope that were sub­ject to in­spec­tions by the FDA this sum­mer, giv­ing the com­pa­ny room to cor­rect the is­sues with­out fac­ing fur­ther reg­u­la­to­ry ac­tion.

The FDA gave Catal­ent a "vol­un­tary ac­tion in­di­cat­ed" re­sponse to two in­spec­tions at the con­tract man­u­fac­tur­er's site in Bloom­ing­ton, IN, and Brus­sels, Bel­gium. Fix­ing the is­sues on its own is a prefer­able out­come to fac­ing an "of­fi­cial ac­tion in­di­cat­ed" re­sponse, mean­ing that an of­fi­cial warn­ing would be sent out or a sit-down with the FDA would be re­quired.

The man­u­fac­tur­er of the “Dog­gy­bone DNA” syn­thet­ic vec­tor has net­ted deals with big names, the lat­est of which is a grant from the Bill & Melin­da Gates Foun­da­tion to help fur­ther Touch­light’s “pre­clin­i­cal de­vel­op­ment” of its vac­cine plat­form.

The vac­cine pro­gram aims to build on ev­i­dence that the syn­thet­ic DNA the com­pa­ny pro­duces can pro­duce strong an­ti­bod­ies and durable T cell re­spons­es fol­low­ing vac­cine ad­min­is­tra­tion.

Ac­cord­ing to the Gates Foun­da­tion, the grant is list­ed at over $2.4 mil­lion and will last for 17 months.

Touch­light said in its an­nounce­ment that its “core fo­cus” is to pro­vide CD­MO ser­vices to ge­net­ic med­i­cine pro­duc­ers. Its Dog­gy­bone DNA prod­uct is al­ready be­ing used in vi­ral vec­tor and mR­NA pro­duc­tion, as well as oth­er DNA vac­cines.

In the sum­mer, Touch­light inked a non-ex­clu­sive patent li­cense agree­ment with Pfiz­er. The deal gave Pfiz­er rights to Touch­light’s DNA prod­uct, to man­u­fac­ture and com­mer­cial­ize mR­NA-based vac­cines and ther­a­peu­tics as well as DNA vac­cines and gene ther­a­pies.

Ex­per­ic, a clin­i­cal sup­ply ser­vices com­pa­ny and CD­MO for the bio­phar­ma in­dus­try, has closed on a Se­ries B fund­ing round, giv­ing the com­pa­ny an­oth­er $14 mil­lion.

The com­pa­ny, which pro­duces a range of prod­ucts, in­clud­ing tablets, cap­sules and dry pow­der prod­ucts, has ex­pe­ri­enced a healthy amount of growth in the past year and has a grow­ing de­mand for for­mu­la­tion, de­vel­op­ment and man­u­fac­tur­ing ser­vices for its pow­er drug prod­ucts and clin­i­cal tri­al sup­plies, which led for the need to raise more funds.

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.

Ac­cord­ing to CPI, the new site is a col­lab­o­ra­tion be­tween the com­pa­ny and 24 oth­er part­ner or­ga­ni­za­tions in phar­ma, acad­e­mia and gov­ern­ment. The site al­so has found­ing part­ners that in­clude GSK, As­traZeneca, the Uni­ver­si­ty of Strath­clyde, and two UK gov­ern­ment agen­cies: UK Re­search and In­no­va­tion and the Scot­tish En­ter­prise, which in­vest­ed £16 mil­lion ($19.1 mil­lion). Oth­er in­vest­ment part­ners in­clude names such as No­var­tis, Pfiz­er, Al­ny­lam, PwC and Siemens, among oth­ers.

UK Gov­ern­ment Min­is­ter for Scot­land John La­m­ont said that £28 mil­lion ($33.4 mil­lion) was giv­en to the fa­cil­i­ty by the UK Gov­ern­ment, through In­no­vate UK.

The site is us­ing what CPI calls a “grand chal­lenge” mod­el that com­bines ideas from both the phar­ma and tech­nol­o­gy sec­tors to at­tack is­sues such as de­vel­op­ing more sus­tain­able man­u­fac­tur­ing process­es.

CPI al­so said that the new site is fore­cast­ed to gen­er­ate £200 mil­lion ($238.6 mil­lion) in ad­vanced man­u­fac­tur­ing tech­nolo­gies over the first five years of op­er­a­tion and cre­ate around 100 jobs as well. The site will al­so plan to take on “start-up risks” that are in­volved with drug de­vel­op­ment, such as com­pli­ance with the reg­u­la­to­ry re­quire­ments for the de­vel­op­ment of new tech.

Dave Tu­dor, the man­ag­ing di­rec­tor of med­i­cines man­u­fac­tur­ing, bi­o­log­ics and qual­i­ty at CPI, said in a state­ment:

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.

In a vis­it to the site by an­a­lysts from SVB Se­cu­ri­ties, Twist’s se­nior man­age­ment shared that the site will not on­ly ex­pand the man­u­fac­tur­ing ca­pac­i­ty for Twist, but it can al­so add new prod­uct ca­pa­bil­i­ties.

Ac­cord­ing to SVB’s analy­sis, the fac­to­ry cur­rent­ly has four “DNA writ­ers” which can each pro­duce around $50 mil­lion in an­nu­al rev­enue, and the fa­cil­i­ty has the room to add eight more. The fac­to­ry al­so pro­vides Twist with the space need­ed to ac­cel­er­ate pro­duc­tion speed more than its oth­er fa­cil­i­ty in San Fran­cis­co, CA.

Man­age­ment al­so told SVB that its prod­ucts can spend up to 50% of their time in stor­age, but the new fac­to­ry will ad­dress this by “con­sol­i­dat­ing in­stru­men­ta­tion and stream­lin­ing in the process.” This will be cru­cial if Twist plans to launch its “Fast Gene” prod­uct in 2023, which is go­ing to ac­cel­er­ate de­liv­ery time for its ex­ist­ing prod­ucts.

The analy­sis al­so em­pha­sized that the com­pa­ny is fo­cused on qual­i­ty con­trol and re­duc­ing er­rors. Be­cause the DNA is writ­ten on a sil­i­con chip plat­form, and these chips are man­u­fac­tured in-house, it lends more process con­trol. It was al­so re­port­ed that each chip that is made un­der­goes “ex­ten­sive” qual­i­ty con­trol and has been reach­ing an even low­er er­ror rate.

Biotech man­u­fac­tur­ing pi­o­neer Re­silience said Tues­day af­ter­noon that it is pur­chas­ing an Ohio-based man­u­fac­tur­ing site from As­traZeneca and build­ing a new part­ner­ship with the UK-based phar­ma.

The fa­cil­i­ty is based in the town of West Chester, OH, just north of Cincin­nati. Re­silience will pro­duce “se­lect” As­traZeneca med­i­cines at the fa­cil­i­ty as part of the sup­ply agree­ment. The fi­nan­cial terms of the agree­ment weren't dis­closed, but the deal is ex­pect­ed to close ear­ly next year.

By ac­quir­ing the West Chester plant, Re­silience will get all the site's phys­i­cal as­sets, re­tain its lead­er­ship and around 500 em­ploy­ees, and plan to in­vest in the work­force and the wider fa­cil­i­ty.

The site it­self is around 580,000 square feet and is equipped with many man­u­fac­tur­ing ca­pa­bil­i­ties, in­clud­ing asep­tic fill­ing, in­spec­tion, pack­ag­ing, cold-chain op­er­a­tions, au­toin­jec­tors, and a vir­tu­al re­al­i­ty train­ing cen­ter.

“We en­vi­sion the West Chester site as our glob­al cen­ter of ex­cel­lence for com­mer­cial drug prod­uct man­u­fac­tur­ing that will pro­duce a wide range of life-sav­ing med­i­cines,” said Re­silience CEO Rahul Singhvi in a state­ment.

Re­silience and As­traZeneca al­so an­nounced on Tues­day that both com­pa­nies will es­tab­lish a long-term bio­man­u­fac­tur­ing re­la­tion­ship to sup­port As­traZeneca's port­fo­lio, with As­traZeneca gain­ing ac­cess to Re­silience’s end-to-end man­u­fac­tur­ing ser­vices.

The ad­di­tion of the West Chester site now gives Re­silience close to two mil­lion square feet of bio­man­u­fac­tur­ing space.

And this move al­so comes dur­ing a pe­ri­od of rapid ex­pan­sion for Re­silience. Af­ter grab­bing $625 mil­lion in Se­ries D fi­nanc­ing this sum­mer, the com­pa­ny quick­ly inked deals with MD An­der­son and the Mayo Clin­ic to es­tab­lish man­u­fac­tur­ing op­er­a­tions at the med­ical cen­ters to try and quick­ly turn around the pro­duc­tion of ther­a­pies.

The Fo­s­un Phar­ma­ceu­ti­cal Group may be con­sid­er­ing the sale of a com­pa­ny it took a stake in just a few years ago.

Ac­cord­ing to a re­port from Bloomberg News on Tues­day, Fo­s­un is con­sid­er­ing the sale of the In­di­an-based in­jectable CD­MO Gland Phar­ma Ltd. af­ter it had re­port­ed­ly re­ceived in­ter­est from po­ten­tial buy­ers.

Bloomberg said in its re­port that Fo­s­un has been work­ing with an ad­vis­er as it in­for­mal­ly “gauges in­ter­est” in its con­trol­ling stake in Gland. Oth­er com­pa­nies and buy­out firms are in the be­gin­ning stages of look­ing at Gland, but no de­tails have emerged on any po­ten­tial buy­ers, the re­port says. The pub­li­ca­tion lists the mar­ket val­ue of Gland at around $3.8 bil­lion.

Fo­s­un bought its con­trol­ling stake in Gland in 2017, buy­ing a 74% stake in the com­pa­ny for $1.1 bil­lion. The Chi­nese phar­ma had orig­i­nal­ly want­ed an 86% stake but was cut back af­ter the In­di­an gov­ern­ment want­ed to ve­to the orig­i­nal plan.

The news has perked up the ears of in­vestors as Fo­s­un and Gland have seen a rise in their stock prices to­day by 3% and 7% re­spec­tive­ly.

How­ev­er, de­spite the re­port­ed in­ter­est in Gland, it is com­ing as a bit of a sur­prise to the man­u­fac­tur­er.

In a let­ter to the Bom­bay Stock Ex­change on Tues­day, Gland clar­i­fied that it is “not aware of any such in­for­ma­tion” that Fo­s­un is con­sid­er­ing the sale of shares of Gland.

“The Com­pa­ny is not in re­ceipt of any com­mu­ni­ca­tion in this re­gard from its Pro­mot­er(s) and is un­able to com­ment on the same,” Gland’s let­ter said.

The UK life sci­ences in­dus­try has al­ways been a a bright spot for its Amer­i­can trade part­ners, but a new re­port from the UK gov­ern­men­t's Board of Trade rais­es some fresh con­cerns about the UK life sci­ences in the post-Brex­it en­vi­ron­ment.

The re­port, pub­lished Mon­day, showed that life sci­ence-re­lat­ed trade be­tween the UK and its US and Eu­ro­pean part­ners de­clined, some­times sub­stan­tial­ly, over the last five years. For in­stance, UK life sci­ences ex­ports from 2016-2021 de­clined by 17% to Spain, -14% to Italy, -13% to Poland, and -11% to Ger­many.

As Brex­it came in­to force in Jan. 2020, the trade re­port notes a "gen­er­al de­cline" in the UK’s man­u­fac­ture of life sci­ence prod­ucts, with ex­ports af­fect­ed, adding:

Claire Machin, the UK bio­phar­ma in­dus­try group's ex­ec­u­tive di­rec­tor of in­ter­na­tion­al pol­i­cy, not­ed in a state­ment that the re­port "cap­tures wor­ry­ing signs that we may be falling be­hind our glob­al com­peti­tors."

She al­so not­ed that the man­u­fac­ture of life sci­ence prod­ucts has seen a rapid de­cline in re­cent years, with the UK falling from 4th to 98th place in over­all trade bal­ance for phar­ma­ceu­ti­cals since 2010.

While Ro­ma­nia may con­jure up im­ages of vast moun­tain ranges and tales of me­dieval kings, one gener­ic man­u­fac­tur­er has bro­ken ground on a new fa­cil­i­ty there.

Ger­man phar­ma com­pa­ny Sta­da said Mon­day that it has placed a €50 mil­lion ($51.9 mil­lion) in­vest­ment in­to a 100,000 square-me­ter (1.08 mil­lion square-foot) site in Tur­da, Ro­ma­nia, a city in the South­east of the coun­try. Ac­cord­ing to a Sta­da spokesper­son in an email to End­points News, the com­pa­ny has de­vel­oped on­ly 281,500 square feet of the site so far.

The site will act as a “sup­ply-chain hub” and ini­tial­ly have nine man­u­fac­tur­ing lines for pro­duc­ing med­i­cines such as tablets and cap­sules and have the abil­i­ty to sup­ply 100 mil­lion packs per year. The fa­cil­i­ty will sup­ply med­i­cines for dis­eases such as di­a­betes, high cho­les­terol and hy­per­ten­sion.

The site will al­so aim to sup­ply a mul­ti­tude of prod­ucts across Eu­rope and will have sig­nif­i­cant ware­hous­ing ca­pa­bil­i­ties.

The ul­ti­mate goal of the fa­cil­i­ty, ac­cord­ing to the Sta­da spokesper­son, is to grow the com­pa­ny’s pres­ence and strength­en the se­cu­ri­ty of med­i­cines in Eu­rope. The com­pa­ny ex­pects to start op­er­a­tions at the fa­cil­i­ty by the end of 2024 and is ex­pect­ing to hire around 375 work­ers.

The Sta­da spokesper­son al­so told End­points that fac­tors such as the pan­dem­ic and oth­er chal­lenges have shown that hav­ing a “ro­bust” med­i­cines sup­ply chain in Eu­rope is vi­tal.

“Through this ma­jor in­vest­ment, Sta­da is fur­ther strength­en­ing its com­mit­ment to act­ing as a re­li­able sup­pli­er of med­i­cines that sup­port health­care sys­tems through­out Eu­rope,” the spokesper­son said to End­points.

The Dan­ish phar­ma gi­ant No­vo Nordisk is mak­ing a ma­jor ex­pan­sion close to home.

The com­pa­ny an­nounced on Tues­day that it plans to in­vest 5.4 bil­lion Dan­ish kro­ner ($747.2 mil­lion) in­to ex­pand­ing its ex­ist­ing fa­cil­i­ties in its home­town of Bagsværd, Den­mark, a sub­urb of Copen­hagen. Those plans al­so in­clude the con­struc­tion of a new plant.

A No­vo Nordisk spokesper­son did not con­firm the size of the new plant to End­points News by press time. How­ev­er, they did tell End­points that de­spite the ex­pan­sion of ex­ist­ing fa­cil­i­ties, the man­u­fac­tur­ing of ac­tive phar­ma­ceu­ti­cal in­gre­di­ents (API) is cur­rent­ly on­go­ing to sup­port clin­i­cal tri­als. The ex­pan­sions are ex­pect­ed to be fi­nal­ized and ful­ly op­er­a­tional in Au­gust of next year for pu­rifi­ca­tion. The new fa­cil­i­ty, which is cen­tered around fer­men­ta­tion and re­cov­ery, is ex­pect­ed to be fi­nal­ized in Au­gust 2024.

No­vo Nordisk al­so plans to cre­ate more ca­pac­i­ty for R&D ac­tiv­i­ties and the pro­duc­tion of APIs, main­ly to sup­ply its clin­i­cal tri­als as well as pro­vide room for fu­ture de­vel­op­ment for its in­jecta­bles and oral med­i­cines, in­clud­ing in the di­a­betes and obe­si­ty treat­ment space, ac­cord­ing to the spokesper­son.

“This in­vest­ment in ex­pand­ing our clin­i­cal API ca­pac­i­ty in Bagsværd is an im­por­tant step to en­sure the con­tin­u­ous progress of our de­vel­op­ment pipeline. In­creas­ing our API ca­pac­i­ty in R&D will be a key en­abler in bring­ing new in­no­va­tions to the mar­ket, and meet the fu­ture de­mand of our pa­tients,” said Jes­per Bøv­ing, se­nior vice pres­i­dent of CMC de­vel­op­ment at No­vo Nordisk, in a state­ment.

As the Japan­ese con­glom­er­ate Fu­ji­film con­tin­ues to in­vest heav­i­ly in its CD­MO arm, one of its man­u­fac­tur­ing di­vi­sions is tee­ing up a ma­jor in­vest­ment.

Fu­ji­film Irvine Sci­en­tif­ic an­nounced on Tues­day that par­ent Fu­ji­film is mak­ing a $188 mil­lion in­vest­ment to build a cell cul­ture me­dia man­u­fac­tur­ing site in the Re­search Tri­an­gle Park in North Car­oli­na. The new site will mark Fu­ji­film Irvine’s fifth man­u­fac­tur­ing site glob­al­ly and its sec­ond in the US.

The 250,000-square-foot site will sit on 64 acres in the re­search park and pro­duce dry pow­der and liq­uid me­dia, with the ca­pac­i­ty to man­u­fac­ture 800,000 kilo­grams per year of dry pow­der and 3.3 mil­lion liters per year of liq­uid me­dia. The site will al­so have a ca­pac­i­ty of 40,000 liters per day of wa­ter for in­jec­tion.

Both the land de­vel­op­ment and con­struc­tion are slat­ed to start in 2023, with pro­duc­tion start­ing in 2025. The com­pa­ny will al­so look to hire around 100 work­ers for the site.

“The cell cul­ture me­dia that will be man­u­fac­tured at this new site in North Car­oli­na will help en­sure a steady sup­ply of raw ma­te­ri­als for bi­o­log­ics, cell and gene ther­a­pies, and oth­er key med­i­cines that are es­sen­tial to hu­man health. The ad­di­tion­al pro­duc­tion ca­pac­i­ty will en­sure we meet the pro­ject­ed de­mand for cell cul­ture me­dia from our cus­tomers world­wide,” said Yu­ta­ka Ya­m­aguchi, Fu­ji­film Irvine Sci­en­tif­ic’s CEO, in a state­ment.