When Sid­dhartha Mukher­jee found­ed Vor Bio­phar­ma in 2016, he had the goal of rewrit­ing the book on stem cell trans­plants. To get there, Vor need­ed a leg up in clin­i­cal man­u­fac­tur­ing — and now it has one.

Vor will build an in-house clin­i­cal man­u­fac­tur­ing fa­cil­i­ty next to its Cam­bridge, MA head­quar­ters, which is is an­tic­i­pat­ed to be up and run­ning in 2022, the com­pa­ny said Thurs­day. The out­lay is all out of pock­et, but Vor says the build­out won't im­pact its cash run­way, which is suf­fi­cient to ear­ly 2023.

The site will sup­port the de­vel­op­ment of en­gi­neered hematopoi­et­ic stem cells (eHSC) and CAR-T can­di­dates for pa­tients with hema­to­log­i­cal ma­lig­nan­cies. It will sup­port clin­i­cal man­u­fac­tur­ing for Vor’s cell ther­a­py pro­grams, with the com­pa­ny plan­ning to add “sev­er­al dozen” em­ploy­ees over the next few years to build off of Vor’s al­ready-ex­ist­ing lease at its Cam­bridge site near the Alewife train sta­tion.

CTO Sadik Kas­sim told End­points News in an in­ter­view Wednes­day that there were three main rea­sons for Vor de­vel­op­ing its own in-house man­u­fac­tur­ing process. For starters, if Vor were to con­tin­ue to out­source to CMOs and CD­MOs, the com­pa­ny would be giv­ing away trade se­crets and with them, any com­pet­i­tive ad­van­tage it may hold.

“The best way to con­trol clin­i­cal de­vel­op­ment is by con­trol­ling man­u­fac­tur­ing in­ter­nal­ly, so the soon­er you do that, the bet­ter po­si­tion you are in long term for en­abling a reg­is­tra­tion tri­al and even a po­ten­tial com­mer­cial launch,” he said.

Life sci­ences con­glom­er­ate Dana­her Corp. DHR has struck a deal to buy the fast-grow­ing Alde­vron, one of the world’s top man­u­fac­tur­ers of hot­ly sought-af­ter plas­mid DNA, mR­NA and re­com­bi­nant pro­teins for the bur­geon­ing world of vac­cine and drug­mak­ers push­ing some game-chang­ing tech­nolo­gies.

Buy­out talks set the stage for Dana­her to set­tle on a $9.6 bil­lion cash pact to ac­quire the pri­vate Far­go, ND-based com­pa­ny — a key sup­pli­er for a dis­rup­tive new Covid vac­cine as well as a host of gene and cell ther­a­py and CRISPR gene edit­ing play­ers — found­ed by Michael Cham­bers and CSO John Bal­lan­tyne as a crew of 2 back in 1998.

At the start of the year, drug gi­ant Bay­er telegraphed its in­tent to ramp up pro­duc­tion of con­tra­cep­tives to help sup­port coun­tries in need. Now, the com­pa­ny is build­ing a new plant in Fin­land and mod­ern­iz­ing an ex­ist­ing plant to help reach that goal.

The project will cost $303 mil­lion and ex­pand the com­pa­ny’s foot­print in Turku, Fin­land’s old­est city. The plant is ex­pect­ed to go on­line by 2025.

“One of these goals is to pro­vide 100 mil­lion women in de­vel­op­ing coun­tries with ac­cess to mod­ern pre­ven­tion and fam­i­ly plan­ning by the end of 2030,” Bay­er Nordic CEO Miri­am Hol­stein said in a state­ment. "In this way, we can in­flu­ence women’s health and so­cial sta­tus, ed­u­ca­tion and fam­i­ly size."

In Jan­u­ary, Bay­er an­nounced the goal of pro­vid­ing con­tra­cep­tion to 100 mil­lion women in low- and mid­dle-in­come coun­tries by 2030. The need for mod­ern  con­tra­cep­tion is un­met for more than 200 mil­lion women, and Covid-19 has made ac­cess to fam­i­ly plan­ning ser­vices even more dif­fi­cult in cer­tain parts of the world, Bay­er said.

The ini­tia­tive has the po­ten­tial to save the lives of 100,000 moth­ers, and pre­vent chil­dren from dy­ing through the pre­ven­tion of un­in­tend­ed preg­nan­cies, the drug­mak­er said.

“We know from the da­ta: when women can plan and space their preg­nan­cies, they are bet­ter able to raise health­i­er fam­i­lies and con­tin­ue to make an eco­nom­ic con­tri­bu­tion,” Bay­er’s head of sus­tain­abil­i­ty Frank Strelow said in a state­ment.

Mod­er­na is turn­ing to one of its Covid-19 vac­cine com­peti­tors to fill its open CMO slot, but this time, it's not the vac­cine ex­pe­ri­ence they're af­ter.

Paul Bur­ton, who's spent 16 years at J&J, most re­cent­ly as chief glob­al med­ical af­fairs of­fi­cer of Janssen, will take over as Mod­er­na CMO on Ju­ly 6.

With an eye to­ward a fu­ture be­yond the pan­dem­ic, the mR­NA biotech went with Bur­ton, who earned his MD and PhD de­grees in Lon­don, as he of­fers ex­pe­ri­ence on a range of ther­a­peu­tic ar­eas, as well as work as a car­dio­tho­racic sur­geon and lead­ing tech projects with Ap­ple.

“Paul’s ex­per­tise across mul­ti­ple ther­a­peu­tic ar­eas and his proven track record lever­ag­ing da­ta sci­ence and dig­i­tal tech­nolo­gies to reimag­ine med­ical en­gage­ment will be in­valu­able," Mod­er­na CEO Stéphane Ban­cel said in a state­ment. "I look for­ward to work­ing with Paul and re-in­vent­ing how med­ical af­fairs should be built and run in a dig­i­tal world.”

Bur­ton will have big shoes to fill even as for­mer CMO Tal Zaks, who cashed out tens of mil­lions in stock be­fore his de­par­ture, will be leav­ing af­ter on­ly six years. Zaks, with sig­nif­i­cant fi­nan­cial and clin­i­cal help from the US gov­ern­ment, led Mod­er­na to its Covid-19 vac­cine suc­cess, cul­mi­nat­ing in the de­vel­op­ment of one of the most lu­cra­tive and life-sav­ing prod­ucts in bio­phar­ma his­to­ry.

In his last quar­ter­ly in­vestor call for the com­pa­ny, Zaks ran down the com­pa­ny’s post-Covid-19 pipeline, in­clud­ing a long list of vac­cines for CMV, RSV, and HIV and tri­als for can­cer vac­cines and rare dis­ease drugs. Ban­cel made clear that they were turn­ing over a new leaf.

A Ger­man CD­MO spe­cial­iz­ing in vi­ral man­u­fac­tur­ing is ex­pand­ing its op­er­a­tions in Eu­rope by build­ing out an ex­ist­ing plant — and soon, it will be its own land­lord, too.

Viba­log­ics has be­gun the first stage of a $50 mil­lion ex­pan­sion of its Cux­haven, Ger­many fa­cil­i­ty, the com­pa­ny an­nounced. It will al­so buy the site out­right from the cur­rent own­er.

The CD­MO spe­cial­izes in the pro­duc­tion of on­colyt­ic virus­es and vi­ral vec­tor-based vac­cines and gene ther­a­py prod­ucts. The ex­pan­sion will add an­oth­er 100,000 square feet at the site for qual­i­ty batch re­lease and sta­bil­i­ty stud­ies, drug prod­uct fill-fin­ish and process de­vel­op­ment.

The site ex­pan­sion will ac­com­mo­date ad­di­tion­al BSL-2 clas­si­fied ar­eas that fea­ture 500-liter sin­gle-use biore­ac­tors for vi­ral-de­rived prod­ucts, in or­der to scale ca­pac­i­ty ef­fi­cient­ly. It will al­so have ad­di­tion­al cell-pro­duc­tion suites and 32,000 square feet of har­vest, fil­tra­tion and pu­rifi­ca­tion tech­nol­o­gy, and an­oth­er 32,000 square feet of ware­house and of­fice space.

Viba­log­ics pres­i­dent Ste­fan Bey­er said in a press re­lease:

In No­vem­ber 2020, the com­pa­ny an­nounced it would in­vest an­oth­er $150 mil­lion in­to its 110,000-square-foot fa­cil­i­ty in Boxbor­ough, MA, in an ef­fort to one day mass pro­duce hun­dreds of gene and cell ther­a­pies. The an­nounce­ment came just about a year af­ter Tom Hochuli came over from Lon­za to take over as CEO.

De­liv­er­ing mR­NA ef­fec­tive­ly and safe­ly in­to the cell is one of the tough­est chal­lenges for ex­pand­ing the use of the ther­a­peu­tics that have tak­en off in pop­u­lar­i­ty as of late. A deal be­tween Ger­many-based spe­cial­ty chem­i­cals com­pa­ny Evonik and Stan­ford Uni­ver­si­ty will help de­vel­op a poly­mer-based de­liv­ery sys­tem for Evonik to li­cense and com­mer­cial­ize.

The com­pa­ny will work with uni­ver­si­ty sci­en­tists to scale up the syn­the­sis and for­mu­la­tion to de­vel­op or­gan se­lec­tive de­liv­ery based on a syn­thet­ic poly­mer through a sys­tem dubbed as CART that was de­vel­oped by Stan­ford pro­fes­sors Robert Way­mouth, Paul Wen­der and Ronald Levy.

Once com­plet­ed, the tech­nol­o­gy will be made avail­able for GMP use in clin­i­cal-stage de­vel­op­ment, and even­tu­al­ly com­mer­cial­ly, if all goes ac­cord­ing to plan. mR­NA de­liv­ery is a lead­ing ob­sta­cle in can­cer im­munother­a­py, pro­tein re­place­ment and gene edit­ing. High­er ups at Evonik think that the com­pa­ny is well-po­si­tion to take on many of the in­dus­try's un­met needs.

The deal is good for three years, and Evonik an­nounced that it hopes the move will help the com­pa­ny in­crease its nu­tri­tion and care di­vi­sion's share of sys­tem so­lu­tions from 20% to more than 50% by 2030.

Evonik's port­fo­lio con­sists of lipid nanopar­ti­cles and cus­tom lipids, for­mu­la­tion de­vel­op­ment and the man­u­fac­tur­ing of clin­i­cal sam­ples and com­mer­cial prod­ucts. Evonik's LNP-based de­liv­ery sys­tems are pro­ject­ed to bring in about $5 bil­lion to the com­pa­ny by 2026, the com­pa­ny says. It ac­quired Tran­f­ser­ra Nanosciences in 2016, and then man­u­fac­tur­er Wilshire Tech­nolo­gies in 2020.

Pres­i­dent Joe Biden's ad­min­is­tra­tion has or­dered an­oth­er round of shots.

Mod­er­na and the US gov­ern­ment have reached a deal that will pro­vide the com­pa­ny with an­oth­er 200 mil­lion dos­es of its Covid-19 vac­cine, and in­clude the op­tion to pur­chase oth­er can­di­dates from the com­pa­ny's pipeline, Mod­er­na an­nounced Wednes­day. The agree­ment brings the to­tal num­ber of Mod­er­na shots to 500 mil­lion. An­oth­er 110 mil­lion will be de­liv­ered in Q4 of 2021 and 90 mil­lion are ex­pect­ed in Q1 of 2021.

As of June 14, the US has re­ceived 217 mil­lion dos­es from Mod­er­na.

“We ap­pre­ci­ate the col­lab­o­ra­tion with the U.S gov­ern­ment for these ad­di­tion­al dos­es of the Mod­er­na COVID-19 vac­cine, which could be used for pri­ma­ry vac­ci­na­tion, in­clud­ing of chil­dren, or pos­si­bly as a boost­er if that be­comes nec­es­sary to con­tin­ue to de­feat the pan­dem­ic,” CEO Stéphane Ban­cel said in a press re­lease.

Tiny UAE is the glob­al leader in per capi­ta terms, and now, it's get­ting a boost from Mod­er­na and a na­tion­al in­vest­ment com­pa­ny to help dis­trib­ute the vac­cine and fu­ture boost­er shots once au­tho­rized.

Ma­gen­ta In­vest­ments, a phar­ma­ceu­ti­cal and health­care com­pa­ny that is a part of a UAE in­vest­ment and in­dus­tri­al con­glom­er­ate, an­nounced plans to dis­trib­ute the shots in 2021 and 2022. The com­pa­ny is a ma­jor play­er in im­prov­ing health in the Mid­dle East and Africa, it said, and is a part of Mawarid Hold­ing In­vest­ment and the Emi­rates Busi­ness Group.

Sil­i­con Val­ley syn­thet­ic bi­ol­o­gy play­er and Roche col­lab­o­ra­tor Sen­ti Bio has been hush-hush about much of its sci­ence since it was found­ed in 2016, but the com­pa­ny made noise Tues­day when it an­nounced it signed a lease agree­ment to build out a com­mer­cial-scale man­u­fac­tur­ing fa­cil­i­ty in Alame­da, CA.

The 92,000 square-foot fa­cil­i­ty will be built with the goal of pro­vid­ing clin­i­cal- and com­mer­cial-scale man­u­fac­tur­ing for off-the-shelf CAR nat­ur­al killer cell can­di­dates. The site will sup­port clin­i­cal tri­als for SEN­TI-202 for acute myeloid leukemia and SEN­TI-301 for he­pa­to­cel­lu­lar car­ci­no­ma. In-house man­u­fac­tur­ing will help Sen­ti main­tain con­trol over sup­ply and qual­i­ty, and is be­ing de­signed to pro­vide end-to-end man­u­fac­tur­ing, as well as stor­age for the fi­nal prod­uct, the com­pa­ny said.

“If our clin­i­cal pro­grams are suc­cess­ful, we be­lieve this fa­cil­i­ty could sup­port the man­u­fac­tur­ing of mul­ti­ple fu­ture prod­uct can­di­dates at both clin­i­cal and com­mer­cial scale,” CTO and co-founder Philip Lee said in a state­ment. “With­in this fa­cil­i­ty, we en­vi­sion bring­ing to­geth­er the lat­est tech­nolo­gies and ex­cep­tion­al man­u­fac­tur­ing tal­ent. We look for­ward to pur­su­ing our goal of cre­at­ing al­lo­gene­ic cell ther­a­pies that can be man­u­fac­tured from healthy donor cells in ad­vance of clin­i­cal use, and then stored in frozen vials to be de­liv­ered rapid­ly to pa­tients in an off-the-shelf man­ner.”

Sen­ti Bio signed a col­lab­o­ra­tion with Blue­Rock in May to de­vel­op mol­e­c­u­lar sen­sors and di­als the com­pa­ny can pro­gram in­to cell ther­a­pies. The com­pa­ny has yet to dis­close any more of its pro­grams yet, ex­cept to say the dis­eases and cell types fall un­der the cat­e­go­ry of im­munol­o­gy, neu­rol­o­gy and car­di­ol­o­gy.

While the UAE leads the world with the high­est per­cent­age of res­i­dents vac­ci­nat­ed, neigh­bor­ing Sau­di Ara­bia — home to near­ly 35 mil­lion peo­ple — has lagged be­hind sig­nif­i­cant­ly. On Fri­day, Mod­er­na an­nounced that it has part­nered with the Sau­di phar­ma­ceu­ti­cal com­pa­ny Tabuk to man­u­fac­ture its jab and fu­ture vari­ant-spe­cif­ic boost­ers in the coun­try.

Tabuk will hold mar­ket­ing au­tho­riza­tion for the vac­cine in Sau­di Ara­bia, and the agree­ment gives them the pos­si­bil­i­ty of dis­trib­ut­ing fu­ture Mod­er­na mR­NA prod­ucts.

Sau­di Ara­bia has vac­ci­nat­ed just 6% of its pop­u­la­tion. The coun­try has had a steady num­ber of around 1,000 cas­es per day since May 20. Since the start of the pan­dem­ic, 7,503 Sau­di Ara­bi­ans have died from the virus, while 461,000 peo­ple have test­ed pos­i­tive.

“As part of our role and mis­sion in Tabuk to de­liv­er unique health so­lu­tions and pre­serve lives for the peo­ple of Sau­di Ara­bia and coun­tries we op­er­ate in es­pe­cial­ly dur­ing the cur­rent pan­dem­ic, our part­ner­ship with Mod­er­na comes in as an ev­i­dent choice to fur­ther sup­port our mis­sion in line with Sau­di vi­sion 2030 re­gard­ing biotech­nol­o­gy in as­so­ci­a­tion with such a dis­tin­guished & renowned com­pa­ny as Mod­er­na," said Mo­hammed Al­hag­bani, the pres­i­dent of As­tra In­dus­tri­al Group, which owns Tabuk.

Mod­er­na has been busy. The com­pa­ny an­nounced a plan to pro­duce as many as 3 bil­lion dos­es of its vac­cine per year, in a move that CEO Stéphane Ban­cel said in an in­ter­view with End­points News was dri­ven by the com­pa­ny's sense of oblig­a­tion in help­ing the rest of the world with vac­cines. At the start of May, though it was late to the par­ty, Mod­er­na pledged 500 mil­lion dos­es to Gavi, the vac­cine al­liance.

Yet an­oth­er com­pa­ny has vol­un­tar­i­ly re­called lots of gener­ic met­formin hy­drochlo­ride, mark­ing the ninth re­call since the start of the year for the Type 2 di­a­betes drug.

Viona Phar­ma­ceu­ti­cals has is­sued a re­call for two lots of its 750 mg ex­tend­ed-re­lease tablets, the FDA said. The prod­uct was re­called af­ter there were lev­els of ni­troso­di­methy­lamine — ND­MA for short — above the ac­cept­able dai­ly lim­it. ND­MA has can­cer-caus­ing po­ten­tial, and is some­times found in meats, dairy prod­ucts and veg­eta­bles.

So far, there have been no re­ports of neg­a­tive side ef­fects from this drug. The af­fect­ed tablets are white to off-white col­ored, cap­sule shaped and un­coat­ed tablets with a ZC on one side and 20 on an­oth­er. The af­fect­ed prod­ucts are in 100-tablet bot­tles, and man­u­fac­tured by Cadi­la Health­care Lim­it­ed in Ahmed­abad, In­dia, in No­vem­ber 2019.

In Jan­u­ary, Nos­trum Lab­o­ra­to­ries twice vol­un­tar­i­ly re­called its gener­ic met­formin. In No­vem­ber 2020, a batch of 500 mg tablets were re­called for the same rea­son. The two batch­es af­fect­ed have an ex­pi­ra­tion date of Oc­to­ber 2021.

Met­formin is used to con­trol glu­cose lev­els in adults with type 2 di­a­betes mel­li­tus. At least eight man­u­fac­tur­ers have re­moved the drug from shelves for el­e­vat­ed ni­trosamine lev­els in the past year. Any­one who has re­ceived some of the af­fect­ed lots of met­formin should con­tin­ue to take their med­ica­tion and con­tact their doc­tor for ad­vise on pur­su­ing fur­ther treat­ment, the FDA says.

"It could be dan­ger­ous for pa­tients with this se­ri­ous con­di­tion to stop tak­ing their met­formin with­out first talk­ing to their health­care pro­fes­sion­als," the re­call no­tice says.