A joint ven­ture be­tween Vi­t­ri­an, a provider of bio­man­u­fac­tur­ing fa­cil­i­ties, and the Howard Hugh­es Cor­po­ra­tion will bring man­u­fac­tur­ing fa­cil­i­ties to the Hous­ton sub­urb of the Wood­lands, TX.

Ac­cord­ing to a press re­lease, the area has sev­er­al com­pa­nies near­by, in­clud­ing Mil­li­pore Sig­ma and KBI Bio­phar­ma. The joint ven­ture aims to meet the needs of lo­cal com­pa­nies by pro­vid­ing a man­u­fac­tur­ing fa­cil­i­ty in the Wood­lands for use by lo­cal biotechs and CD­MOs as well.

Ac­cord­ing to Vi­t­ri­an co-founder and man­ag­ing prin­ci­pal Scott Nudel­man, the com­pa­ny pre­vi­ous­ly part­nered with Cel­lipont Bioser­vices on its new HQ and man­u­fac­tur­ing site in the Wood­lands area, which is lead­ing to a deep­er com­mit­ment lo­cale. How­ev­er, no oth­er de­tails on the new project have been re­vealed as of yet.

“The dy­nam­ic en­vi­ron­ment and ameni­ty base cre­at­ed and nur­tured by Howard Hugh­es pro­vides a unique place to at­tract and re­tain life sci­ence com­pa­nies and their work­force,” Nudel­man said in the re­lease.

UK’s NHS opens a new cell and gene ther­a­py pro­duc­tion site

The Na­tion­al Health Ser­vice’s Blood and Trans­plant (NHS­BT) di­vi­sion has opened the new fa­cil­i­ty, dubbed the Clin­i­cal Biotech­nol­o­gy Cen­tre, lo­cat­ed out­side the city of Bris­tol, UK. The new cen­ter was es­tab­lished with a £10 mil­lion ($12.1 mil­lion) grant from the UK gov­ern­ment.

The new site is de­signed to make clin­i­cal-grade prod­ucts for cell and gene ther­a­py R&D. It will al­so man­u­fac­ture prod­ucts for dis­eases such as sick­le cell, cys­tic fi­bro­sis and some forms of can­cer.

“The CBC will help the UK grow its cell and gene ther­a­py in­dus­try in a rapid­ly grow­ing in­ter­na­tion­al mar­ket. We won’t be de­sign­ing the treat­ments, but we will be man­u­fac­tur­ing them to the right scale and clin­i­cal grade. Cell and gene ther­a­py is a grow­ing area for the health­care sec­tor and part of our di­rec­tion of trav­el as an or­gan­i­sa­tion,” said Lil­ian Hook, the NHS­BTs di­rec­tor of cell, aphaere­sis and gene ther­a­pies, in a re­lease.

Ever­green Ther­ag­nos­tics nets $15M in its lat­est fund­ing round

The New Jer­sey-based ra­dio­phar­ma­ceu­ti­cal CD­MO Ever­green Ther­ag­nos­tics has wrapped up a $15 mil­lion Se­ries B raise.

On the back of the fund­ing, the CD­MO is launch­ing a new unit of its busi­ness, dubbed Ever­green Dis­cov­ery. This unit will be fo­cused on de­vel­op­ing new ra­dio­phar­ma­ceu­ti­cals for can­cer ther­a­py. The com­pa­ny has al­so hired Thomas Rein­er as its chief sci­en­tif­ic of­fi­cer, who pre­vi­ous­ly served as the head of ra­di­oli­gand ther­a­py drug dis­cov­ery at Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions, a No­var­tis com­pa­ny. Ever­green Dis­cov­ery will al­so be based in a new re­search fa­cil­i­ty near Prince­ton, NJ some­time in the third quar­ter of this year.

“Launch­ing Ever­green Dis­cov­ery rep­re­sent­ed the next log­i­cal step for us, and we are ex­cit­ed to have re­cruit­ed Thomas as a leader of this new team. With Ever­green Dis­cov­ery, we will de­vel­op nov­el ra­dio­phar­ma­ceu­ti­cals to ad­dress some of the most ur­gent un­met clin­i­cal needs,” said James Cook, Pres­i­dent and CEO of Ever­green Ther­ag­nos­tics, in a re­lease.

Ever­green will al­so use the cash to pre­pare for the launch of Ga-68 DOTA­TOC if it is ap­proved. The CD­MO will be build­ing out its com­mer­cial ca­pa­bil­i­ties and staffing as well as prepar­ing in­ven­to­ry.

Sai Life Sci­ences sets up a new UK lab

Sai Life Sci­ences has es­tab­lished a GMP “Ki­lo Lab” at its fa­cil­i­ty in Man­ches­ter, UK, al­low­ing the com­pa­ny to of­fer drug sub­stance sup­plies to its cus­tomers.

The new lab will have the ca­pac­i­ty to pro­duce up to 35 liters of prod­uct, with room to add more ca­pac­i­ty in the fu­ture, along with space for oth­er an­a­lyt­i­cal ser­vices to cus­tomers.

“The new lab, lo­cat­ed clos­er to our cus­tomers, has been set up with com­pre­hen­sive cGMP con­trols and world-class in­fra­struc­ture. The fa­cil­i­ty will com­bine with our ex­per­tise in route scout­ing, process chem­istry and scale-up, to help our part­ners ac­cel­er­ate their drug dis­cov­ery and de­vel­op­ment jour­neys by re­duc­ing time to first-in-hu­man clin­i­cal tri­als,” said Sai Life Sci­ences COO Sauri Gud­laval­leti, in a state­ment.

Two French com­pa­nies part­ner up

The bio­ther­a­peu­tics CD­MO GTP Bioways and the CRO Tex­cell, which spe­cial­izes in as­say de­vel­op­ment and GMP bank­ing, are en­gag­ing in a part­ner­ship to pro­vide end-to-end ser­vices to sup­port the de­vel­op­ment of ther­a­peu­tics to cus­tomers across the globe.

The part­ner­ship will see GTP Bioways pro­vide bio­man­u­fac­tur­ing and de­vel­op­ment ser­vices for cus­tomers ,while Tex­cell will pro­vide greater in­ter­na­tion­al reach for the part­ner­ship with its of­fices and lab­o­ra­to­ries in France as well as Chi­na, Japan, the US and Ger­many.

“Tex­cell and GTP Bioways share the same busi­ness phi­los­o­phy. We are both sci­ence-dri­ven and cus­tomer-cen­tric com­pa­nies and be­lieve in em­pa­thy, in­tegri­ty, and trans­paren­cy to build the suc­cess of our cus­tomer’s pro­grams. It is thus quite nat­ur­al that our long busi­ness re­la­tion­ship turned in­to a deep­er part­ner­ship,” said Alain Sain­sot, pres­i­dent of GTP Bioways in a re­lease.

Por­ton Ad­vanced So­lu­tions inks deal with Ben­nu Bio­ther­a­peu­tics

The cell and gene ther­a­py CD­MO Por­ton Ad­vanced So­lu­tions has se­cured a strate­gic part­ner­ship with Ben­nu Bio­ther­a­peu­tics with a goal to boost the de­vel­op­ment of T-cell ther­a­pies for tu­mors and au­toim­mune dis­eases.

The terms of the agree­ment will see Pro­ton pro­vid­ing CD­MO ser­vices for mul­ti­ple pipelines in cell and gene ther­a­py, how­ev­er, the fi­nan­cial terms of the time­line of the deal were not dis­closed.

“Through our end-to-end Cell and Gene Ther­a­py CD­MO, Por­ton Ad­vanced aims to help Ben­nu Bio­ther­a­peu­tics de­vel­op mul­ti­ple pipelines for cell ther­a­py prod­ucts, ac­cel­er­ate the de­vel­op­ment of in­no­v­a­tive drugs such as TIL, and bring these ben­e­fi­cial drugs to mar­ket as soon as pos­si­ble,” said Yangzhou Wang, CEO of Pro­ton Ad­vanced, in a re­lease.

Cell One Part­ners and the Cen­ter for Break­through Med­i­cines form a strate­gic part­ner­ship

The con­sult­ing out­fit Cell One Part­ners and the CD­MO Cen­ter for Break­through Med­i­cines (CBM) have formed a strate­gic part­ner­ship to com­mer­cial­ize cell and gene ther­a­pies.

The deal will aim to com­bine Cell One’s strate­gic ca­pa­bil­i­ties and guid­ance of cell and gene ther­a­py biotechs with the man­u­fac­tur­ing of the Cen­ter for Break­through Med­i­cines.

“A strate­gic part­ner­ship with Cell One Part­ners pro­vides CGT de­vel­op­ers ac­cess to Cell One Part­ners’ vir­tu­al C-Suite ex­ec­u­tives and strate­gic ad­vi­sors and ac­cess to CBM’s ex­pan­sive ca­pac­i­ty, breadth of CGT tech­nolo­gies, R&D, process de­vel­op­ment and GMP man­u­fac­tur­ing ex­per­tise, al­low­ing in­no­va­tors to fo­cus on re­search, ex­tend cash run­way, sim­pli­fy a com­plex sup­ply chain, and ac­cel­er­ate the de­vel­op­ment and man­u­fac­tur­ing of their ther­a­pies,” said Jen­nifer Man­ning the SVP of glob­al strate­gic part­ner­ships at CBM, in a re­lease.

Om­ni­aBio to man­u­fac­ture Cata­ma­ran Bio’s cell ther­a­pies

The Cana­di­an man­u­fac­tur­er Om­ni­aBio will be de­vel­op­ing and pro­duc­ing Cata­ma­ran Bio’s al­lo­genic CAR-NK cell ther­a­pies that are de­signed to treat sol­id tu­mors.

The deal will see Om­ni­aBio de­vel­op cell ther­a­py at its sites in Toron­to, which al­lows the man­u­fac­tur­er to go be­tween de­vel­op­ment and man­u­fac­tur­ing on a clin­i­cal scale. No oth­er de­tails on the deal were re­leased.

“This col­lab­o­ra­tion will al­low us to de­vel­op scal­able process­es for the ro­bust GMP man­u­fac­ture of our off-the-shelf CAR-NK cell ther­a­pies,” says Alvin Shih, Cata­ma­ran Bio’s CEO in a re­lease.

Al­ca­mi names new chief man­u­fac­tur­ing of­fi­cer

Al­ca­mi has ap­point­ed Jamie Iu­di­ca to the po­si­tion of chief man­u­fac­tur­ing of­fi­cer.

Iu­di­ca has over 25 years of ex­pe­ri­ence in the phar­ma­ceu­ti­cal world, hav­ing pre­vi­ous­ly served as chief man­u­fac­tur­ing of­fi­cer at Is­tari On­col­o­gy. He has al­so served in sev­er­al man­u­fac­tur­ing and lead­er­ship po­si­tions at com­pa­nies such as Pfiz­er, Hos­pi­ra and Xel­lia Phar­ma­ceu­ti­cals.

“Jamie’s ex­ten­sive ex­per­tise in drug prod­uct man­u­fac­tur­ing op­er­a­tions will be in­te­gral as we ex­pand the Al­ca­mi man­u­fac­tur­ing and op­er­a­tions foot­print,” said Al­ca­mi CEO Patrick Walsh, in a state­ment.

Al­ca­mi al­so an­nounced that COO Ken Do­ma­gal­s­ki will re­tire lat­er this year.

Ju­bi­lant Hol­lis­ter­Sti­er an­nounces a new pres­i­dent

Ju­bi­lant Hol­lis­ter­Sti­er has named Chris Preti as its new pres­i­dent.

Preti has 25 years of ex­pe­ri­ence in R&D, sales, mar­ket­ing and op­er­a­tions. He was most re­cent­ly the pres­i­dent of Hol­lis­ter­Sti­er Al­ler­gy and has al­so held po­si­tions at Glax­o­SmithK­line.

“This is an ex­cit­ing time to join Ju­bi­lant Hol­lis­ter­Sti­er, as the com­pa­ny con­tin­ues to ex­pand its ca­pac­i­ty to ad­dress grow­ing in­dus­try de­mand for the high-qual­i­ty ser­vices we pro­vide,” Preti said in a state­ment emailed to End­points News.

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Catalent will be manufacturing a low-cost version of the opioid overdose treatment naloxone as part of a contract with Harm Reduction Therapeutics.

Catalent plans to manufacture the treatment at its facility in Morrisville, NC. No financial details on the deal were disclosed.

Harm Reduction was granted priority review status for the NDA on its spray last year. The company has been working on a naloxone product since 2017. It is anticipating approval in July of this year and a US launch in early 2024.

Last year, South African-based vaccine manufacturer Aspen Pharmacare was facing reports that it had not received a single order for its manufactured Covid-19 shots and that manufacturing lines were sitting idle. But now the vaccine producer is looking to turn things around.

Aspen’s disclosure of its financial results in March unveiled that manufacturing revenue had decreased by 12% to R 603 million ($33.8 million), which Lorraine Hill, Aspen Group’s COO, said is attributable to lower Covid vaccine sales.

Thermo Fisher Scientific is putting down more roots in the Bay Area.

The manufacturer opened the doors to a new cell therapy manufacturing facility next to the University of California-San Francisco Medical Center’s Mission Bay campus and on the university’s campus.

UCSF and Thermo Fisher have had a partnership since 2021, with the new site focusing on manufacturing cell therapeutics for certain cancers, including glioblastoma and multiple myeloma. The new site plans to use Thermo Fisher’s expertise in manufacturing services to help UCSF accelerate the development of cell therapies and eventually get them into the clinic, said Dan Herring, the general manager of cell therapy services at Thermo Fisher, in an interview with Endpoints News.

Dallas-based biotech Nanoscope Therapeutics unveiled Phase II results on its gene therapy for a rare eye disease Thursday morning.

In the RESTORE trial, 18 patients with retinitis pigmentosa got a gene therapy called MCO-010 while nine got placebo. On a vision test called the MLYMT, the treatment group had a one-point greater change over one year in their score compared to the placebo group, the primary endpoint of the study. However, the 95% confidence interval was 0.0 to 3.0, meaning the result was not statistically significant. The p-value was not provided.