Dur­ing End­points News' time in San Diego for #BIO22, it was hard to miss all the Sam­sung Bi­o­log­ics signs plas­tered along­side the high­way to the air­port, adorn­ing near­ly every lamp post. How­ev­er, ad­ver­tis­ing is not the on­ly place where Sam­sung is look­ing to spend.

Last month, it was re­port­ed that South Ko­rea’s Sam­sung Group raised spend­ing by more than 30% to KRW 450 tril­lion, or around $360 bil­lion, to in­vest in sev­er­al lines of busi­ness in­clud­ing elec­tron­ics and biotech, among oth­ers. Sam­sung Bi­o­log­ics CEO John Rim spoke to End­points at #BIO22 to dis­cuss how this in­vest­ment will af­fect the biotech arms of one of South Ko­rea’s largest con­glom­er­ates.

Rim said that a sig­nif­i­cant por­tion of that mon­ey will be in­vest­ed in­to biotech, but a hard fig­ure was not giv­en to End­points. Rim did in­di­cate that the com­pa­ny is build­ing out a plat­form that will be com­plet­ed around Oc­to­ber, with it com­ing ful­ly on­line next year on the back of the in­vest­ment.

Al­so, the com­pa­ny is in the process of pur­chas­ing ad­di­tion­al land, dubbed Bio Cam­pus Two, which will be ad­ja­cent to their cur­rent 60-acre cam­pus in Song­do, South Ko­rea. Rim said their cur­rent cam­pus is now ful­ly oc­cu­pied and is now in need of ex­pan­sion. This new cam­pus will be planned to be ful­ly staffed with­in the next 10 years and be 30% larg­er, Rim said. Ac­cord­ing to a reg­u­la­to­ry fil­ing, the com­pa­ny will spend around KRW 426 Bil­lion, or $347 mil­lion, to ac­quire the land for the new 80-acre cam­pus.

As drug man­u­fac­tur­ing star­tups gain more no­to­ri­ety with in­vestors, most no­tably with the re­cent deals sur­round­ing Re­silience, an­oth­er start­up is look­ing to take its next steps in the space on the back of a Se­ries B raise.

Boston-based Elek­trofi, which has been around since 2016, has net­ted a $40 mil­lion Se­ries B round, the com­pa­ny an­nounced Mon­day. Elek­trofi is pri­mar­i­ly fo­cused on man­u­fac­tur­ing sev­er­al kinds of med­i­cines in­clud­ing mon­o­clon­al an­ti­bod­ies, ther­a­peu­tic pro­teins and oth­er large mol­e­cule drugs.

Elek­trofi CEO Chase Coff­man told End­points News that the com­pa­ny has been work­ing to de­vel­op a new way to de­liv­er drugs, with a par­tic­u­lar fo­cus on an­ti­body-based ther­a­pies. The idea is to shift the set­ting of care from the clin­ic in­to the home with self-ad­min­is­tered ther­a­pies.

Coff­man said that Elek­trofi aims to stray from the paths of tra­di­tion­al biotech in the sense that the com­pa­ny is not de­vel­op­ing its pro­pri­etary suite of prod­ucts or pipelines.

“In­stead, what we're do­ing is we're team­ing up with ma­jor multi­na­tion­al bio­phar­ma­ceu­ti­cal com­pa­nies ... to de­vel­op new and im­proved at-home self-ad­min­is­ter sub­cu­ta­neous prod­ucts around their as­sets us­ing our de­liv­ery plat­form,” he said.

The com­pa­ny so far has man­aged to se­cure con­tracts with sev­er­al ma­jor com­pa­nies in­clud­ing Take­da and LEO Phar­ma, cen­tered around plas­ma and mon­o­clon­al an­ti­body pro­duc­tion, re­spec­tive­ly.

For the raise it­self, Coff­man said it came about very quick­ly with the com­pa­ny on­ly mar­ket­ing the raise around Jan­u­ary, which he stressed was crit­i­cal as the mar­ket gets ever more pre­car­i­ous for biotechs.

A Cal­i­for­nia-based CD­MO will be look­ing to ex­pand its ca­pa­bil­i­ties in its home state to keep up with mar­ket de­mand.

Avid Bioser­vices is ex­pand­ing its lab­o­ra­to­ries in Tustin, Cal­i­for­nia around its ca­pac­i­ty for its mam­malian cell busi­ness.

The in­vest­ment is priced at $6 mil­lion, and the 4,500-square-foot ex­pan­sion is ex­pect­ed to be com­plet­ed by the end of the year. No out­side funds were nec­es­sary and the com­pa­ny used cash on hand to fund the project. This ex­pan­sion tails oth­er in­vest­ments the com­pa­ny has made to in­crease process de­vel­op­ment ca­pac­i­ty in 2019 and 2022.

Ex­pand­ing its lab­o­ra­to­ries could sup­port an ad­di­tion­al $20 mil­lion in an­nu­al process de­vel­op­ment rev­enue, dou­bling the com­pa­ny’s cur­rent process de­vel­op­ment ca­pac­i­ty, ac­cord­ing to a state­ment.

“Avid is fo­cused on en­sur­ing that it al­ways has avail­able ca­pac­i­ty to meet the needs of its cus­tomers (cur­rent and fu­ture),” said Nick Green, CEO of Avid, in an email to End­points News. “This lat­est project will gen­er­ate ad­di­tion­al up­stream and down­stream process de­vel­op­ment ca­pac­i­ty at the front-end of the mam­malian cell busi­ness, which is crit­i­cal for the ef­fi­cient on-board­ing of new cus­tomer projects.”

This comes on the heels of Avid open­ing an an­a­lyt­i­cal and process de­vel­op­ment suite with­in the com­pa­ny’s cGMP man­u­fac­tur­ing fa­cil­i­ty. The launch of these is to ex­pand its CD­MO ser­vice of­fer­ing in­to the rapid­ly grow­ing cell and gene ther­a­py mar­ket, with the com­pa­ny look­ing to ful­fill those ca­pa­bil­i­ties in 2023.

The FDA com­plet­ed less than half (48%) of its reg­u­la­to­ry ac­tions for phar­ma fa­cil­i­ties des­ig­nat­ed as OAI or with an Of­fi­cial Ac­tion In­di­cat­ed, with­in 6 months of an in­spec­tion clos­ing, ac­cord­ing to the lat­est re­port from the agency on the ef­fects Covid-19 had on gen­er­al over­sight at man­u­fac­tur­ing sites last year.

The agency al­so lost pace in is­su­ing fi­nal fa­cil­i­ty clas­si­fi­ca­tion let­ters.

In FY 2021, the re­port not­ed FDA is­sued 70% of fi­nal fa­cil­i­ty clas­si­fi­ca­tion let­ters with­in 90 days of in­spec­tion clos­ing. By com­par­i­son, in FY 2019, 87% of fi­nal fa­cil­i­ty clas­si­fi­ca­tion let­ters were is­sued with­in 90 days of in­spec­tion clos­ing, and com­plet­ed 74% of reg­u­la­to­ry ac­tions for OAI fa­cil­i­ties.

Pan­dem­ic mit­i­ga­tion ef­forts such as trav­el re­stric­tions have im­pact­ed the num­ber of in­spec­tions con­duct­ed by the FDA as re­sources were be­ing di­vert­ed to the pan­dem­ic re­sponse.

The back­log at the FDA has been well doc­u­ment­ed. In 2021, the Gov­ern­ment Ac­count­abil­i­ty Of­fice de­tailed that the FDA did not con­duct any new in-per­son in­spec­tions of Covid-19 vac­cine man­u­fac­tur­ing plants be­fore is­su­ing the EUAs for Pfiz­er, Mod­er­na and J&J’s shots. Mean­while, the agency in­stead had to re­ly on his­tor­i­cal find­ings for the 18 man­u­fac­tur­ing sites.

While the FDA is­sued mea­sures on con­duct­ing vir­tu­al eval­u­a­tions to get a han­dle on the back­log, there were still ma­jor lim­i­ta­tions to the re­mote pro­gram, and it on­ly filled a frac­tion of the in­spec­tions in the agency’s back­log.

The num­bers for 2022 will most like­ly not im­prove too much as even ear­li­er this year, the FDA qui­et­ly an­nounced it once again paused all its non-mis­sion-crit­i­cal in­spec­tions in the US, but those in­spec­tions have since re­turned to nor­mal.

Amidst a hail of in­vest­ments com­ing from South Ko­re­an con­glom­er­ates in­to biotech, in­clud­ing Lotte and Sam­sung, SK is look­ing to get in on the ac­tion.

SK Pharmte­co, a CD­MO and sub­sidiary of the sec­ond-largest con­glom­er­ate in South Ko­rea, is in­vest­ing $35 mil­lion to ex­pand SK’s phar­ma­ceu­ti­cal man­u­fac­tur­ing plant in the Dublin sub­urb of Swords, Ire­land, in­clud­ing a new build­ing.

Ac­cord­ing to SK, the ex­pan­sion project will pro­vide an in­crease in the site’s man­u­fac­tur­ing ca­pac­i­ty and ca­pa­bil­i­ties, com­ing on­line some­time in 2024.

The first phase of the project will in­clude a new man­u­fac­tur­ing build­ing, which will aim to in­crease re­ac­tor vol­ume ca­pac­i­ty. The new build­ing will al­so con­tain fil­tra­tion and dry­ing equip­ment, as­so­ci­at­ed util­i­ties and the ca­pa­bil­i­ty for ad­di­tion­al man­u­fac­tur­ing lines and tech­nolo­gies in fu­ture phas­es of the project.

The ex­pan­sion will hap­pen over two phas­es, with ad­di­tion­al fund­ing for sub­se­quent phas­es. On com­ple­tion, the ex­pan­sion will re­sult in an over­all 50% in­crease in ca­pac­i­ty at the Swords cam­pus.

“With sub­stan­tial growth in our busi­ness base, this ex­pan­sion sup­ports SK biotek Ire­land’s po­si­tion as a key con­trib­u­tor to SKPT’s EU and world­wide busi­ness,” said Joyce Fitzhar­ris, pres­i­dent of SK biotek Ire­land, in a state­ment.  The new plant will be lo­cat­ed on the foot­print of a de­com­mis­sioned pro­duc­tion build­ing on-site, with­in prox­im­i­ty to SK’s oth­er site fa­cil­i­ties.

This is the sec­ond ma­jor ex­pan­sion project SK has em­barked on. In 2020, the Swords Cam­pus com­plet­ed a $30 mil­lion re­ac­tor ca­pac­i­ty ex­pan­sion.

The cam­pus has been around for 60 years as a small mol­e­cule API man­u­fac­tur­er, pro­duc­ing on­col­o­gy and car­di­ol­o­gy treat­ments.

Swiss-based CD­MO ten23 is on the move as it com­mits to ex­pand­ing its man­u­fac­tur­ing pres­ence in Switzer­land just af­ter an­nounc­ing an­oth­er ex­pan­sion ear­li­er this year.

The com­pa­ny is ex­pand­ing its swiss­fil­lon man­u­fac­tur­ing site in Visp, which was ac­quired in Oc­to­ber 2021. While the cost of the ex­pan­sion was not dis­closed to End­points News, the new build­ing will add over 5,000 square me­ters of space over four floors, or around 54,000 square feet. The com­pa­ny will al­so add 100 jobs.

In this new fa­cil­i­ty, ten23 health plans to build two more ster­ile man­u­fac­tur­ing lines, with the pos­si­bil­i­ty of adding a third. One of the new lines is a scaled-up ver­sion of its ex­ist­ing fill­ing line and will pro­vide GMP fill and fin­ish ca­pac­i­ty for com­mer­cial and clin­i­cal use. The to­tal ca­pac­i­ty of this line is es­ti­mat­ed to pro­duce 20 mil­lion units and the line is ex­pect­ed to be op­er­a­tional in 2024.

Ten23’s oth­er line will have the abil­i­ty to fill bulk con­tain­ers, both in liq­uid and lyophilized form, with two larg­er-scale freeze-dri­ers each at 12.5 square me­ters of shelf space, for both clin­i­cal and com­mer­cial use. The an­nu­al to­tal ca­pac­i­ty of this line is es­ti­mat­ed to serve around 12.5 mil­lion units.

The phys­i­cal su­per­struc­ture of the new build­ing is ex­pect­ed to be com­plet­ed by the end of sum­mer, but no time­line for the com­ple­tion of the in­ner build­out has been giv­en to End­points.

“The sig­nif­i­cant ex­pan­sion of our pro­duc­tion ca­pac­i­ty for sy­ringe and cap­sule fill­ing, and tech­ni­cal ca­pa­bil­i­ties of fill­ing and lyophiliza­tion of ster­ile prod­ucts in bulk vials, is a clear com­mit­ment for Switzer­land and will en­able our cus­tomers to pro­vide treat­ment op­tions for their pa­tients,” said ten23 CEO Hanns-Chris­t­ian Mahler.

As com­pa­nies both large and small are con­tin­u­ing to place bets on ra­di­oli­gand ther­a­pies, the man­u­fac­tur­ing in­dus­try is ex­pand­ing to ac­com­mo­date the ris­ing in­ter­est.

In­di­ana-based Spec­tron­Rx is plan­ning to con­struct a new fa­cil­i­ty for pro­duc­ing ac­tini­um-225, which has yet to win FDA ap­proval. Spec­tron­Rx has se­cured more than 10 acres in Bunker Hill, IN, a town halfway be­tween In­di­anapo­lis and South Bend. The square footage of the fa­cil­i­ty has not been fi­nal­ized, ac­cord­ing to the com­pa­ny, but it will aim to pro­duce Ac-225 for use in clin­i­cal tri­als and com­mer­cial sup­ply of can­cer-fight­ing ther­a­pies.

Ac­cord­ing to Spec­tron­Rx the com­pa­ny is in­vest­ing mil­lions of dol­lars in the project, putting put es­ti­mates north of $20 mil­lion, with plans to hire 25 new em­ploy­ees. The com­pa­ny said it has ap­plied for state eco­nom­ic de­vel­op­ment as­sis­tance to com­plete the project.

How­ev­er, while the com­pa­ny is push­ing for­ward with Ac-225 pro­duc­tion, the com­pound isn’t wide­ly used now.

“Al­though there’s cur­rent­ly no (FDA)-ap­proved treat­ment us­ing Ac-225, it’s show­ing great promise when it comes to the treat­ment of cer­tain types of can­cer, in­clud­ing prostate, breast, colon, brain, and neu­roen­docrine,” said John Zehn­er, CEO of Spec­tron­Rx in a state­ment.

In an email to End­points News, Sprec­tron­Rx pres­i­dent An­wer Rizvi said that us­ing Ac-225 is show­ing great promise for treat­ing cer­tain types of can­cer, in­clud­ing prostate, breast, colon, brain and neu­roen­docrine.

“But un­for­tu­nate­ly, there is a lim­it­ed sup­ply of Ac-225, with on­ly small amounts of it be­ing pro­duced by var­i­ous gov­ern­ment en­ti­ties. This lim­its the abil­i­ty of phar­ma com­pa­nies to per­form the R&D need­ed to ad­vance the use of this cru­cial ra­dionu­clide. And once treat­ments are ap­proved, sup­plies will be­come even more lim­it­ed with­out bet­ter pro­duc­tion, that’s why Spec­tron­Rx is build­ing this new fa­cil­i­ty,” he said.

Oth­er com­pa­nies have been bull­ish on man­u­fac­tur­ing the com­pound, es­pe­cial­ly in the Hoosier state.

Ear­li­er this year, bio­man­u­fac­tur­er Point re­ceived ac­tini­um-225 from the DOE’s Iso­tope Pro­gram to sup­port its ear­ly-stage pipeline and in-house man­u­fac­tur­ing of lutetium-177, a ra­dioac­tive med­i­cine that binds it­self to tu­mor cells at its new 80,000-square-foot site in In­di­ana that Point billed as one of the largest ra­di­oli­gand fa­cil­i­ties in the world.

As the world faces a grow­ing chal­lenge of pathogens re­sis­tant to an­tibi­otics, Sh­iono­gi and the GARDP have com­mit­ted to an ex­e­cu­tion of a li­cense and tech­nol­o­gy trans­fer agree­ment with the Clin­ton Health Ac­cess Ini­tia­tive (CHAI).

Ac­cord­ing to Sh­iono­gi, the col­lab­o­ra­tion agree­ment will aim to in­crease ac­cess to an­tibi­otics for coun­tries around the world, with an em­pha­sis on low­er- and mid­dle-in­come na­tions. The agree­ment will fo­cus on ce­fide­ro­col, an an­tibi­ot­ic for the treat­ment of se­ri­ous Gram-neg­a­tive bac­te­r­i­al in­fec­tions.

De­spite bumps in the road in get­ting the drug off the ground, ce­fide­ro­col was even­tu­al­ly added to the WHO’s mod­el list of es­sen­tial med­i­cines and does tar­get sev­er­al Gram-neg­a­tive WHO pri­or­i­ty pathogens. The drug was even­tu­al­ly ap­proved by the FDA in 2019 and by the EMA in 2020.

“Sh­iono­gi is com­mit­ted to en­sur­ing that ce­fide­ro­col is ac­ces­si­ble world­wide as a po­ten­tial treat­ment op­tion for cer­tain high­ly re­sis­tant Gram-neg­a­tive in­fec­tions,” said Takuko Sawa­da, SVP of the in­te­grat­ed dis­ease care di­vi­sion at Sh­iono­gi, in a state­ment.

Ac­cord­ing to Sh­iono­gi, the agree­ment will see GARDP man­u­fac­ture and com­mer­cial­ize ce­fide­ro­col through sub-li­censees to around 135 coun­tries that have de­layed ac­cess to new­er an­tibi­otics. The li­cense in­cludes all low-in­come coun­tries, low­er mid­dle- and up­per mid­dle-in­come coun­tries, and se­lect high-in­come coun­tries. The deal al­so in­cludes a sig­nif­i­cant pro­por­tion of the world’s pop­u­la­tion liv­ing in ar­eas most af­fect­ed by an­tibi­ot­ic re­sis­tance.

Fi­nan­cial de­tails of the deal were not dis­closed.

The agree­ment al­so in­cludes pro­vi­sions to work with min­istries of health and oth­er ex­perts to strength­en hos­pi­tal-based stew­ard­ship pro­grams that en­sure ap­pro­pri­ate use. These pro­vi­sions are es­pe­cial­ly im­por­tant to avoid fu­el­ing re­sis­tance to ce­fide­ro­col.

While some coun­tries are in the midst of on­go­ing ne­go­ti­a­tions with Covid-19 vac­cine sup­pli­ers now that the sup­ply of pan­dem­ic shots is start­ing to out­weigh de­mand, Mod­er­na is dou­bling down on pro­duc­tion in a Eu­ro­pean na­tion  — throw­ing more than half a bil­lion dol­lars to start things off.

Mod­er­na is in­vest­ing 500 mil­lion eu­ros in­to Spain — with the biotech con­firm­ing af­ter Spain's prime min­is­ter Pe­dro Sánchez tweet­ed out Tues­day.

In Eng­lish, it reads:

A Mod­er­na spokesper­son told End­points News in a state­ment that "Mod­er­na has a sig­nif­i­cant in­vest­ment in the coun­try through its man­u­fac­tur­ing part­ner­ship with ROVI and foot­print in Spain. In 2022, we ex­pect this in­vest­ment to be ap­prox­i­mate­ly $530 mil­lion."

Mod­er­na had pre­vi­ous­ly an­nounced a 10-year deal with Span­ish CMO Rovi back in Feb­ru­ary to in­crease man­u­fac­tur­ing ca­pac­i­ty for Mod­er­na's Covid-19 vac­cine Spike­vax, and po­ten­tial­ly uti­lize Rovi's plat­form for fu­ture mR­NA vac­cine can­di­dates. Fi­nan­cials of that Feb­ru­ary deal were not dis­closed.

Af­ter an in­spec­tion in Feb­ru­ary, the FDA has re­vealed con­cern­ing ob­ser­va­tions at a man­u­fac­tur­ing fa­cil­i­ty be­long­ing to Rentschler Bio­phar­ma in Ger­many.

The fa­cil­i­ty, a drug sub­stance man­u­fac­tur­ing site in the small south­ern Ger­man city of Laupheim, had nine ob­ser­va­tions not­ed by FDA in­spec­tors.

The first ob­ser­va­tion not­ed that the sim­u­lat­ed fill process had no RPM spec­i­fi­ca­tion for the pump and no doc­u­men­ta­tion for RPM set­tings dur­ing drug sub­stance dis­pens­ing to be avoid­ed. The process is al­so not con­trolled to an es­tab­lished spec­i­fi­ca­tion.

The in­spec­tion al­so found two redact­ed pieces of equip­ment hav­ing rings of dis­col­oration be­low the top of the as­sem­bly, with no root cause in­di­cat­ed and no for­mal risk as­sess­ment or cor­rec­tive ac­tion to ad­dress the dis­col­oration.

Lab­o­ra­to­ry pro­ce­dures or test­ing to as­sure com­pli­ance with es­tab­lished spec­i­fi­ca­tions and stan­dards are not avail­able, FDA said. Equip­ment and fa­cil­i­ty sys­tems in sup­port of man­u­fac­tur­ing were al­so not ad­e­quate­ly val­i­dat­ed.

The FDA found that re­ject­ed ma­te­ri­als are not al­ways con­trolled to pre­vent their unau­tho­rized use and re­ject­ed ma­te­ri­als were not al­ways con­trolled un­der quar­an­tine.

The com­pa­ny al­so failed to es­tab­lish an ad­e­quate sys­tem for mon­i­tor­ing en­vi­ron­men­tal con­di­tions of crit­i­cal process equip­ment, fa­cil­i­ties and equip­ment in sup­port of man­u­fac­ture.

This comes at a time when Rentschler is mak­ing sev­er­al moves. The com­pa­ny ex­pand­ed its site in Mass­a­chu­setts last year, and has been look­ing to bump up its in­vest­ment in cell and gene ther­a­pies over the next five years. The Ger­man CD­MO opened a new site at the Cell and Gene Ther­a­py Cat­a­pult in the UK, al­low­ing Rentschler to es­tab­lish the man­u­fac­tur­ing of vi­ral vec­tors for clin­i­cal sup­ply.

The FDA de­liv­ered a laun­dry list of cit­ed prob­lems to a Eu­ro­pean man­u­fac­tur­er with pro­duc­tion line is­sues that in­clud­ed mi­cro­bi­o­log­i­cal con­t­a­m­i­na­tion and im­prop­er clean­ing pro­ce­dures. The Form 483 was sent to Span­ish drug ma­te­ri­als man­u­fac­tur­er Bioiber­i­ca's ma­te­ri­als man­u­fac­tur­ing plant in Palafolls, north of Barcelona.

In an in­spec­tion be­tween Jan. 31 and Feb. 4 this year the FDA found that clean­ing pro­ce­dures for the equip­ment used in the drug sub­stance man­u­fac­tur­ing were not val­i­dat­ed as nec­es­sary to en­sure ad­e­quate clean­ing and con­t­a­m­i­na­tion pre­ven­tion mea­sure. The FDA al­so found mi­cro­bi­o­log­i­cal con­t­a­m­i­na­tion and a lack of es­tab­lished con­trol pro­ce­dures to mon­i­tor the out­put man­u­fac­tur­ing process­es that could po­ten­tial­ly cause vari­abil­i­ty in the drug sub­stance.

The plan­t's qual­i­ty con­trol unit al­so lacked the re­spon­si­bil­i­ty to ap­prove all pro­ce­dures or spec­i­fi­ca­tions around iden­ti­ty, strength, qual­i­ty and pu­ri­ty of sub­stances and had no writ­ten test­ing pro­gram to as­sess the sta­bil­i­ty char­ac­ter­is­tics.

The FDA found that writ­ten records of in­ves­ti­ga­tions in­to pre­vi­ous dis­crep­an­cies didn’t al­ways in­clude con­clu­sions and jus­ti­fied fol­low-ups. The in­spec­tors not­ed that was par­tic­u­lar­ly prob­lem­at­ic around in­ves­ti­ga­tions of mi­cro­bi­o­log­i­cal non-con­for­mi­ties for an un­named USP drug.

Bioiber­i­ca man­u­fac­tures a wide range of prod­ucts for an­i­mal, plant and hu­man health. For hu­mans, the com­pa­ny pro­duces Glu­cosamine API, sev­er­al he­parin com­pounds and Ten­dax­ion, among a slew of oth­er com­pounds.

This marks the first time the com­pa­ny has re­ceived a warn­ing from the FDA.

Re­genxbio is push­ing deep­er in­to the gene ther­a­py space with the open­ing of a new fa­cil­i­ty at its cam­pus in the Wash­ing­ton D.C., sub­urb of Rockville, MD.

Built in a year, the $65 mil­lion, 132,000-square-foot GMP fa­cil­i­ty will en­able the com­pa­ny to boost its man­u­fac­tur­ing of NAV Tech­nol­o­gy-based ade­no-as­so­ci­at­ed virus, or AAV, vec­tors at scales up to 2,000 liters. The fa­cil­i­ty will al­so im­ple­ment Re­genxbio’s plat­form sus­pen­sion cell cul­ture process.

“We be­lieve our in-house man­u­fac­tur­ing ca­pa­bil­i­ties will en­able us to rapid­ly tran­si­tion pro­duc­tion process­es across the prod­uct life­cy­cle, and ef­fi­cient­ly ad­vance new AAV Ther­a­peu­tics from re­search and ear­ly de­vel­op­ment to clin­i­cal pro­grams to com­mer­cial readi­ness, and in­to the hands of pa­tients who may ben­e­fit from these po­ten­tial one-time ad­min­is­tra­tion ther­a­pies,” said Re­genxbio’s CEO Ken Mills in a state­ment.

The site now in­cludes two in­de­pen­dent bulk drug sub­stance pro­duc­tion suites, a fi­nal drug prod­uct suite and in­te­grat­ed qual­i­ty con­trol labs, and pro­duc­tion at the site be­gan in May.

Mills said in an email to End­points News, that the com­pa­ny re­ceived $800,000 in fi­nanc­ing in­cen­tives from the gov­ern­ment of Mont­gomery Coun­ty and the state of Mary­land for the build­out of their head­quar­ters, which in­cludes the new man­u­fac­tur­ing cen­ter. Aside from an­oth­er es­ti­mat­ed $19.5 mil­lion in ten­ant im­prove­ment al­lowances, the rest of the project was fund­ed di­rect­ly by Re­genxbio. No debt was in­curred re­lat­ed to the build-out.

Last year, the com­pa­ny in­vest­ed more than $100 mil­lion in­to the build­out of its head­quar­ters in Rockville and the com­pa­ny has made over 200 hires in the past two years bring­ing its to­tal to over 400 peo­ple, with more than 100 ded­i­cat­ed to man­u­fac­tur­ing.

One of the ba­sic lessons in sci­ence class is that mi­to­chon­dria act as the pow­er­house of the cell. But LU­CA Sci­ence, a Japan­ese biotech, is look­ing to take it a step fur­ther.

The com­pa­ny is look­ing to har­ness the pow­er of mi­to­chon­dria to even­tu­al­ly cre­ate ther­a­pies for or­gan and tis­sue re­pair, and on Mon­day it closed a $30.3 mil­lion Se­ries B. Helmed by Rick Tsai, a Mer­ck and Al­ler­gan vet, LU­CA aims to re­search the mi­to­chon­dri­a's po­ten­tial in ob­stet­rics, res­pi­ra­to­ry, car­dio­vas­cu­lar, CNS, im­munol­o­gy and on­col­o­gy spaces.

Tsai ex­plains that the com­pa­ny us­es spe­cial mi­to­chon­dria that are dif­fer­ent from tra­di­tion­al meth­ods, as ex­tract­ed mi­to­chon­dria can be high­ly del­i­cate. As such, LU­CA has spent its time de­vel­op­ing a way to iso­late in­tact, func­tion­al mi­to­chon­dria. Tsai said that when the com­pa­ny’s mi­to­chon­dria are ex­tract­ed and thawed, the mem­brane po­ten­tial is still pre­served, al­low­ing for it to be ap­plied to fur­ther re­search and de­vel­oped in­to even­tu­al ther­a­pies.

Tsai not­ed that oth­er com­pa­nies and sci­en­tists work­ing in this field are fo­cused on us­ing the cur­rent­ly avail­able meth­ods for mi­to­chon­dria, main­ly as in­di­rect ap­proach­es to dis­ease treat­ment. What sets LU­CA apart, Tsai said, is how they ap­ply their mi­to­chon­dria for di­rect us­age.

“We can store it and then still main­tain the func­tion, so for the first time, we can ac­tu­al­ly use al­lo­gene­ic mi­to­chon­dria and make it off-the-shelf as the prod­uct,” he said. “This will open up doors for emer­gency sit­u­a­tions and many dif­fer­ent ther­a­pies and make it in­to like a bio­phar­ma­ceu­ti­cal prod­uct.”