Roche is plan­ning to make some changes to its sub­sidiary’s man­u­fac­tur­ing net­work in Cal­i­for­nia.

The Swiss phar­ma an­nounced Wednes­day that it plans to di­vest from Genen­tech’s man­u­fac­tur­ing fa­cil­i­ty in Va­cav­ille, CA, around 58 miles north­east of San Fran­cis­co. Ac­cord­ing to a state­ment from Roche, the move is part of a “broad­er strat­e­gy” to bring its man­u­fac­tur­ing ca­pa­bil­i­ties in line with its fu­ture pipeline. Roche is start­ing the process of find­ing a buy­er for the site but has not named any can­di­dates yet.

The Va­cav­ille plant, which has more than 427,000 square feet of space for man­u­fac­tur­ing, ware­hous­ing, lab­o­ra­to­ry ser­vice and of­fice space, was ac­quired by Genen­tech in 1994 and is one of the old­est pro­duc­tion sites in the Roche net­work, com­ing in­to the fold when Roche ac­quired Genen­tech over a decade ago. The site has been re­spon­si­ble for the large-scale man­u­fac­tur­ing of bi­o­log­i­cal med­i­cines.

“The Va­cav­ille site has a 25-year lega­cy of pro­duc­ing in­no­v­a­tive med­i­cines for mil­lions of pa­tients around the world. We aim to find a buy­er who shares our val­ues and re­spects the con­tri­bu­tions and ex­per­tise of our col­leagues at the fa­cil­i­ty,” Su­sanne Hunds­baek-Ped­er­sen, the glob­al head of phar­ma tech­ni­cal op­er­a­tions at Roche, said in the me­dia state­ment.

Hunds­baek-Ped­er­sen added that the process has no im­pact on op­er­a­tions or em­ploy­ees.

Roche’s state­ment said that Genen­tech is still com­mit­ted to large-scale pro­duc­tion at oth­er lo­ca­tions and will be sup­port­ed at one of its new­er fa­cil­i­ties. But as Roche and Genen­tech con­tin­ue to work on cell ther­a­pies and more per­son­al­ized vac­cines, they're look­ing to in­crease pro­duc­tion of these in­di­vid­u­al­ized med­i­cines and trim large-scale bi­o­log­ics man­u­fac­tur­ing.

Richard Paz­dur, di­rec­tor of the FDA’s On­col­o­gy Cen­ter of Ex­cel­lence, at­trib­ut­es the cur­rent short­age of two can­cer drugs to drug com­pa­nies that haven't in­vest­ed in build­ing out their pro­duc­tion ca­pac­i­ty.

In an in­ter­view with The Can­cer Let­ter, a week­ly can­cer pub­li­ca­tion, Paz­dur said that the cur­rent short­ages of cis­platin and car­bo­platin, a pair of drugs used to treat a wide range of can­cer pa­tients, are the re­sult of two prob­lems: man­u­fac­tur­ers not in­vest­ing in en­hanc­ing pro­duc­tion ca­pac­i­ty, and drug com­pa­nies be­ing de­pen­dent on one sup­pli­er of raw in­gre­di­ents. The cis­platin short­age fol­lowed an in­spec­tion that re­vealed qual­i­ty is­sues at a man­u­fac­tur­ing fa­cil­i­ty, which then led to the shut­down of pro­duc­tion. This led to a surge in car­bo­platin de­mand, cre­at­ing a sec­ondary short­age.

The short­ages are caus­ing on­col­o­gists across the US to ra­tion plat­inum-based drugs, ac­cord­ing to The Can­cer Let­ter.

To re­store the sup­ply of cis­platin, the FDA is of­fer­ing as­sis­tance to all man­u­fac­tur­ers to help boost pro­duc­tion, Paz­dur said. The reg­u­la­tor is al­so look­ing at “tem­po­rary im­por­ta­tion” op­tions to damp­en the sit­u­a­tion and ask­ing man­u­fac­tur­ers to give the FDA more da­ta about ex­pi­ra­tion dates for prod­ucts that have been dis­trib­uted.

How­ev­er, Paz­dur not­ed that the agency’s ju­ris­dic­tion to man­age short­ages is lim­it­ed. Cur­rent laws don't re­quire pro­duc­ers to re­port an in­crease in de­mand, and the FDA can­not tell man­u­fac­tur­ers what to make or how much to pro­duce — or con­trol the sup­ply chains for drugs.

Af­ter lin­ing up a string of part­ner­ships over the years, Dutch an­ti­body-drug con­ju­gate spe­cial­ist Synaf­fix has found a new home: Lon­za, the con­tract de­vel­op­ment and man­u­fac­tur­ing gi­ant.

Lon­za is pay­ing about $107 mil­lion (€100 mil­lion) in cash to ac­quire Synaf­fix, with up to $64 mil­lion (€60 mil­lion) in “ad­di­tion­al per­for­mance-based con­sid­er­a­tion” on the ta­ble. Synaf­fix’s ADC tech plat­form will now be­come part of Lon­za’s of­fer­ing for bio­phar­ma clients, lend­ing its bio­con­ju­gate tech­nolo­gies to not just AD­Cs but al­so tar­get­ed gene ther­a­py, im­mune cell en­gagers and oth­er ap­pli­ca­tions.

Com­pa­nies that li­cense Synaf­fix’s tech­nolo­gies can now tap in­to Lon­za’s tech­nol­o­gy and man­u­fac­tur­ing plat­form “as they progress in­to the late-stage clin­i­cal and com­mer­cial de­vel­op­ment phase,” Pe­ter van de Sande, Synaf­fix CEO, added.

Since its found­ing in 2010, Synaf­fix has made out-li­cens­ing its main fo­cus, at­tract­ing com­pa­nies from all cor­ners of the world — ADC Ther­a­peu­tics in Switzer­land, Am­gen in Thou­sand Oaks, CA, Macro­Gen­ics in Rockville, MD, Miraco­gen in Chi­na, Hum­ming­bird in Sin­ga­pore, among oth­ers.

With tools to aid in all as­pects of ADC de­vel­op­ment — at­tach­ing a pay­load to an an­ti­body, se­lect­ing the best pay­load, en­hanc­ing the po­ten­cy of the com­pound, ex­tend­ing its half-life and so on — Ul­rich Os­s­wald, Lon­za’s VP of li­cens­ing, called the Synaf­fix tech­nol­o­gy “the gold stan­dard.”

“The ac­qui­si­tion of Synaf­fix un­der­lines the strate­gic po­si­tion of bio­con­ju­gates with­in Lon­za’s port­fo­lio, ex­pands our of­fer­ing in this fast-grow­ing mar­ket and en­hances our val­ue propo­si­tion for clin­i­cal cus­tomers,” he said in a state­ment.

Green­Light Bio­science, the de­vel­op­er and man­u­fac­tur­er of RNA vac­cines and ther­a­peu­tics, is set to be ac­quired.

The com­pa­ny an­nounced ear­li­er this week that it would be ac­quired by a group of buy­ers led by Fall Line Cap­i­tal in a cash deal valu­ing Green­Light at around $45.5 mil­lion. Ac­cord­ing to a re­lease, Fall Line and the group agreed to ac­quire all of the shares of the com­pa­ny for $0.30 per share. The deal is ex­pect­ed to close some­time in the third quar­ter of this year.

A new­ly formed hold­ing com­pa­ny will own 100% of Green­Light and no longer trade on Nas­daq. Green­Light has al­so re­ceived $15 mil­lion in cash and $15 mil­lion in un­se­cured notes to give it some work­ing cap­i­tal for the time be­ing.

How­ev­er, no ma­jor de­tails were giv­en as to the com­pa­ny's fu­ture di­rec­tion, or if this ac­tion will lead to any lay­offs or ma­jor changes. End­points News reached out to Green­Light for more in­for­ma­tion but did not get a re­sponse.

While Green­Light has been mak­ing head­way with its Covid-19 mR­NA vac­cine, which start­ed test­ing in Rwan­da ear­li­er this year, the deal comes as the com­pa­ny has al­so hit some speed­bumps.

Green­Light has seen a falloff in its stock price GR­NA and has been rel­e­gat­ed to the pen­ny stock zone since Feb­ru­ary. Green­Light al­so re­duced staff by 25% last Oc­to­ber as part of a wider re­align­ment.

That de­ci­sion aimed to have Green­Light fo­cus on “near-term val­ue dri­vers” as well as give it more cash. It al­so in­te­grat­ed its “plat­form team” in­to re­spec­tive teams for plant and hu­man health, caus­ing a staff re­duc­tion.

Astel­las Phar­ma is sell­ing its man­u­fac­tur­ing plant in Mep­pel, the Nether­lands, to con­tract man­u­fac­tur­er Del­pharm.

Astel­las said last week it's trans­fer­ring the fa­cil­i­ty to Del­pharm as part of a wider shift for the phar­ma’s tech­nol­o­gy and man­u­fac­tur­ing busi­ness. As part of the deal, for which fi­nan­cial de­tails were not dis­closed, Del­pharm plans to con­tin­ue to pro­duce the prod­ucts that are made in the Mep­pel plant for Astel­las. The em­ploy­ees at the site will al­so trans­fer to Del­pharm as well. The deal is ex­pect­ed to close by the end of the year.

The Mep­pel plant cur­rent­ly has 332 em­ploy­ees and pro­duces tablets, gran­ule med­i­cines and cap­sules.

A Dr. Red­dy’s Lab­o­ra­to­ry sub­sidiary that of­fers CD­MO ser­vices is in­vest­ing in its pro­duc­tion ap­pa­ra­tus.

Au­ri­gene Phar­ma­ceu­ti­cal Ser­vices is look­ing to pro­duce ther­a­peu­tic pro­teins, an­ti­bod­ies and vi­ral vec­tors, in­vest­ing $40 mil­lion in­to an R&D and pi­lot-scale fa­cil­i­ty in Hy­der­abad, In­dia. The fa­cil­i­ty aims to meet the sup­ply and de­vel­op­ment needs of biotechs and plans to be op­er­a­tional by the first half of 2024.

“We see an in­creased out­sourc­ing de­mand from glob­al bio­phar­ma­ceu­ti­cal com­pa­nies," Au­ri­gene CEO Akhil Ravi said in a re­lease. "With this ex­pan­sion in bio­ther­a­peu­tics CD­MO, we will be po­si­tioned to pro­vide in­te­grat­ed ser­vices from clin­i­cal re­search to com­mer­cial man­u­fac­tur­ing for small and large mol­e­cules.”

Plas­ma­Gen Bio­sciences, a Ben­galu­ru, In­dia-based biotech, ​​has opened a new man­u­fac­tur­ing plant.

The FDA has warned the pub­lic that com­pound­ed ver­sions of pop­u­lar GLP-1 drugs Ozem­pic and We­govy may not in­clude the same in­gre­di­ents as the pre­scrip­tion med­ica­tions, and that has raised ques­tions about their safe­ty and ef­fec­tive­ness.

The reg­u­la­tor said Tues­day it has re­ceived re­ports of ad­verse events re­lat­ed to com­pound­ed ver­sions of semaglu­tide, the ac­tive in­gre­di­ent in Ozem­pic and We­govy. Some prod­ucts be­ing mar­ket­ed as semaglu­tide con­tain the salt for­ma­tion of semaglu­tide, which is not con­sid­ered safe or ef­fec­tive.

No­vo Nordisk’s Ozem­pic and We­govy, both of which con­tain semaglu­tide, are ap­proved to treat type 2 di­a­betes and obe­si­ty, and de­mand for the drugs has soared over the last two years, giv­en the abil­i­ty of both ther­a­pies to help peo­ple lose weight. That de­mand has cre­at­ed a sup­ply crunch, with both med­ica­tions on the FDA’s short­ages list.

Though com­pound­ing med­ica­tions is le­gal when drug short­ages oc­cur, the com­pound­ed ver­sions of drugs need to fol­low re­quire­ments set out in the Food, Drug, and Cos­met­ic Act.

“The agency is not aware of any ba­sis for com­pound­ing us­ing the salt forms that would meet the FD&C re­quire­ments for types of ac­tive in­gre­di­ents that can be com­pound­ed,” the reg­u­la­tor said.

The FDA said it con­tact­ed the Na­tion­al As­so­ci­a­tion of Boards of Phar­ma­cy last month, stat­ing its con­cerns with com­pound­ing phar­ma­cies us­ing the salt forms of semaglu­tide.

“We are not aware of any ba­sis for com­pound­ing a drug us­ing these semaglu­tide salts that would meet fed­er­al law re­quire­ments that lim­it the types of ac­tive in­gre­di­ents that can be used in com­pound­ing,” the FDA wrote in an April 27 let­ter.

Emer­gent BioSo­lu­tions, a vac­cine and ther­a­peu­tic man­u­fac­tur­er for de­fense pur­pos­es, is ce­ment­ing its small­pox vac­cine pro­duc­tion sta­tus by ink­ing a con­tract with the US gov­ern­ment.

On Tues­day, Emer­gent an­nounced that it has a con­tract to de­liv­er the ACAM200 small­pox vac­cine to the Strate­gic Na­tion­al Stock­pile. Emer­gent said in a re­lease that this op­tion is the third of nine an­nu­al con­tract ex­ten­sions, with this ex­ten­sion be­ing worth around $120 mil­lion. The con­tract is al­so a part of Emer­gent’s 10-year, $2 bil­lion deal with HHS’s Of­fice of the As­sis­tant Sec­re­tary for Pre­pared­ness and Re­sponse set up in 2019.

“This op­tion rep­re­sents the im­por­tance the US gov­ern­ment places in prepar­ing for the threat of small­pox. It al­so high­lights the val­ue placed by the US gov­ern­ment in main­tain­ing do­mes­tic man­u­fac­tur­ing ca­pa­bil­i­ties and the im­por­tance of pub­lic-pri­vate part­ner­ships in ad­dress­ing known and un­known pub­lic health threats,” Paul Williams, SVP and prod­ucts busi­ness head at Emer­gent, said in the re­lease.

Last Sep­tem­ber, the man­u­fac­tur­er se­cured the glob­al rights to Tem­bexa, buy­ing the small­pox an­tivi­ral from the North Car­oli­na-based biotech Chimerix. As a re­sult of the deal, Emer­gent took over Chimerix’s 10-year BAR­DA con­tract and will pro­duce 1.7 mil­lion dos­es of the drug, with the val­ue of the con­tract sit­ting at $680 mil­lion, as well as a “prod­uct pro­cure­ment” val­ued at $115 mil­lion. Ad­di­tion­al op­tions are val­ued at $551 mil­lion, at BAR­DA’s dis­cre­tion.

Emer­gent has an­oth­er small­pox treat­ment in its ar­se­nal. Vac­cinia Im­mune Glob­u­lin In­tra­venous (VI­GIV) is used to treat com­pli­ca­tions of small­pox vac­ci­na­tion. Emer­gent has pre­vi­ous­ly se­cured a con­tract op­tion with the US to man­u­fac­ture VI­GIV for more than $60 mil­lion.

UCB, a Brus­sels-based bio­phar­ma­ceu­ti­cal com­pa­ny, had sev­er­al is­sues cit­ed by FDA in­spec­tors at a man­u­fac­tur­ing fa­cil­i­ty in Bel­gium, but the com­pa­ny is not pan­ick­ing.

Ac­cord­ing to a 483 re­port, the FDA in­spect­ed UCB’s man­u­fac­tur­ing fa­cil­i­ty in Braine-l’Alleud, Bel­gium, be­tween April 17 and 21 of this year, with in­spec­tors find­ing three sig­nif­i­cant ob­ser­va­tions.

The FDA found is­sues with the qual­i­ty unit at the fa­cil­i­ty sur­round­ing its con­trol of doc­u­ments. The re­port said that UCB had “un­con­trolled” logs record­ing clean­ing ac­tiv­i­ties in clas­si­fied ar­eas, among oth­er ex­am­ples of “un­con­trolled” logs be­ing used. In­spec­tors al­so found shred­ded doc­u­ments at the fa­cil­i­ty but had no as­sur­ance that the ma­te­ri­als did not con­tain qual­i­ty doc­u­ments.

The re­port al­so said that the swab sam­ples af­ter the fill­ing of cer­tain sy­ringes were found to be in­ad­e­quate as cer­tain ar­eas, which were redact­ed in the re­port, were not swabbed af­ter man­u­fac­tur­ing. In­spec­tors al­so found an em­ploy­ee mov­ing their up­per body in­side a re­strict­ed ac­cess bar­ri­er (RABS), but on­ly left and right hands are al­lowed be­hind the RABS.

A UCB spokesper­son told End­points News that there are no open in­for­ma­tion re­quests or on­go­ing ques­tions from the FDA, and every­thing the agency brought up has been ad­dressed.