Astellas joins Pfizer in emerging North Carolina hub, unveiling new $100M gene therapy manufacturing site

The small metropolis of San­ford, NC, was as soon as identified for its brick professional­duc­tion, however now could be fast­ly be­com­ing a hub within the biotech world. And now Astel­las Phar­ma­ceu­ti­cals is the lat­est to pitch its tent within the space.

The com­pa­ny’s gene ther­a­py department, which got here out of the ac­qui­si­tion of Au­dentes in 2019, has opened a brand new man­u­fac­tur­ing fa­cil­i­ty within the metropolis, com­pris­ing 135,000 sq. ft and shelling out $100 mil­lion. Astel­las de­signed the positioning to professional­vide clin­i­cal and com­mer­cial-scale man­u­fac­tur­ing ca­pa­bil­i­ties for its pipeline of AAV vec­tors for gene ther­a­pies, which in­cludes professional­grams from each Astel­las’s and Au­dentes’s port­fo­lios.

Wednes­day’s in­vest­ment will al­so sup­port glob­al sup­ply chain wants and in-house qual­i­ty con­trol check­ing, in addition to the cre­ation of greater than 200 jobs by means of 2026. Cur­lease­ly, round 50 peo­ple are al­prepared em­ployed on the web site.

Math­ew Pletch­er, di­vi­sion head of gene ther­a­py re­search and tech­ni­cal op­er­a­tions at Astel­las, stated that San­ford is an effective lo­ca­tion be­trigger it may professional­vide sufficient area for the ini­tial construct, however is al­so massive sufficient for any fu­ture ex­pan­sions if want­ed. Pletch­er al­so stated this transfer places Astel­las in an space that’s fast­ly be­com­ing a ma­jor hub for ge­internet­ic med­i­cine and man­u­fac­tur­ing.

Its new fa­cil­i­ty is simply down the highway from a 230-acre Pfiz­er man­u­fac­tur­ing web site that has been heav­i­ly in­vest­ing in gene ther­a­py ca­pa­bil­i­ties, ac­wire­ing to a re­port from NCbiotech. In 2021, Aben­za al­so se­lect­ed San­ford for a $200 mil­lion bi­o­log­ics plant that can even­tu­al­ly home round 24,000 sq. ft of biore­ac­tor ca­pac­i­ty.

“This space of North Automotive­oli­na is fast­ly be­com­ing a hub of ge­internet­ic med­i­cine and man­u­fac­tur­ing, and so you may take a look at it two methods. Sure, that cre­ates some com­pe­ti­tion for the work­drive, nevertheless it al­so speaks to the truth that now there’s a re­al nu­cle­us of ex­per­tise be­ing gen­er­at­ed,” Pletch­er stated.

As to why Astel­las felt it want­ed the plant, Pletch­er stated the com­pa­ny rec­og­nizes that AAV man­u­fac­tur­ing re­mains a choke level for the in­dus­strive, stat­ing there are nonetheless lim­i­ta­tions in terms of each ca­pa­bil­i­ty and ca­pac­i­ty. And as Astel­las strikes its ther­a­pies to­ward the clin­ic, the com­pa­ny will want extra ac­cess to clin­i­cal-grade ma­te­r­i­al that may sup­port a glob­al roll­out.

“Simply to make the ma­te­r­i­al… at value and to satisfy the targets and the wants of our develop­ing port­fo­lio, we had been go­ing to want greater than what we had in South San Fran­cis­co,” he stated.

Pletch­er al­so not­ed the brand new fa­cil­i­ty locations Astel­las close to ma­jor col­le­giate in­sti­tu­tions comparable to Duke and the Uni­ver­si­ty of North Automotive­oli­na. Whereas no for­mal re­la­tion­ships have been cast, Pletch­er hopes to lever­age this con­nec­tion to each iden­ti­fy tal­ent and pos­si­bly forge extra aca­d­e­m­ic half­ner­ships.

And whereas the com­pa­ny is com­mit­ted to its new lo­ca­tion, their South San Fran­cis­co fa­cil­i­ty will con­tin­ue to play a ma­jor function. San­ford will fo­cus pri­mar­i­ly on clin­i­cal sup­ply and even­tu­al com­mer­cial sup­ply, whereas the Cal­i­for­nia web site can work to assist sup­port its ear­ly port­fo­lio, as it’s clos­er to the cell and gene ther­a­py re­search hub.

Pletch­er sees the brand new plant as not only a strategy to roll out gene ther­a­py el­e­ments, however as a strategy to en­gage the biotech in­dus­strive as a way to half­ner with small­er com­pa­nies.

“The size and the scope of the in­vest­ment that Astel­las is mak­ing in gene ther­a­py, as rep­re­despatched­ed by this fa­cil­i­ty, simply speaks to its com­mit­ment to the area and the vi­sion of the im­por­tance of gene ther­a­py and the fu­ture of med­i­cine,” he stated. “After which ul­ti­mate­ly, what this web site al­lows us to do is to assume glob­al­ly, to assume broad­ly, to consider the place we will take our port­fo­lio and plat­type with­out hav­ing a few of the lim­i­ta­tions that I believe, par­tic­u­lar­ly within the biotech area, re­al­ly squeeze numerous these com­pa­nies.”