Man­u­fac­tur­ing roundup: GSK opens a new fa­cil­i­ty at Barnard Cas­tle lo­ca­tion; Tenaya Ther­a­peu­tics com­pletes build­out of Bay Area ge­net­ic med­i­cine man­u­fac­tur­ing site

GSK is con­tin­u­ing to build out its Barnard Cas­tle site in the UK.

Ac­cord­ing to the com­pa­ny, it has opened a new asep­tic smart man­u­fac­tur­ing fa­cil­i­ty at the site, which is lo­cat­ed in Coun­ty Durham in the north­east of Eng­land.

The new fa­cil­i­ty, known as Q Block, is a ful­ly au­to­mat­ed and dig­i­tal fa­cil­i­ty that lever­ages dig­i­tal tech­nol­o­gy to make man­u­fac­tur­ing op­er­a­tions as ef­fi­cient as pos­si­ble.

The 11,500-square-me­ter fa­cil­i­ty start­ed con­struc­tion in 2018 and ac­cord­ing to the UK news site Busi­ness Live, the costs for the new build­ing were £90 mil­lion, or around $110 mil­lion.

“The Q Block fa­cil­i­ty puts GSK and Barnard Cas­tle at the fore­front of med­i­cines man­u­fac­ture and I am de­light­ed the site will play such an im­por­tant role in sup­port­ing the de­liv­ery of our in­no­v­a­tive pipeline,” said Eliz­a­beth Row­both­am, site di­rec­tor for Barnard Cas­tle.

The fa­cil­i­ty will look to man­u­fac­ture ex­ist­ing and new bio­phar­ma­ceu­ti­cal as­sets in GSK’s port­fo­lio, how­ev­er, the de­tails on what will be pro­duced or how many new jobs this will cre­ate have not been re­vealed to End­points News.

Barnard Cas­tle is one of GSK’s largest man­u­fac­tur­ing sites in the UK, em­ploy­ing around 1,000 peo­ple and sup­ply­ing near­ly half a mil­lion packs of prod­ucts per day to 140 mar­kets. The site it­self was found­ed in 1945.

Swe­den’s NorthX Bi­o­log­ics is en­ter­ing the cell ther­a­py man­u­fac­tur­ing game with Alder

Swedish-based NorthX Bi­o­log­ics, a tra­di­tion­al man­u­fac­tur­ing ser­vice with ex­per­tise in plas­mids, pro­teins and oth­er com­pounds is look­ing to en­ter a new and in­creas­ing­ly com­pet­i­tive mar­ket.

The com­pa­ny is ex­pand­ing in­to cell ther­a­py man­u­fac­tur­ing at its ex­ist­ing GMP fa­cil­i­ty, as well as in premis­es in Mat­fors, Swe­den at the Karolin­s­ka Uni­ver­si­ty Hos­pi­tal cam­pus in Stock­holm.

Ac­cord­ing to the com­pa­ny, this ini­tia­tive is part of NorthX’s In­no­va­tion Hub, a mea­sure de­signed to pro­vide de­vel­op­ment and GMP-man­u­fac­tur­ing ser­vices to the drug de­vel­op­ment com­pa­nies and re­search groups who are work­ing on more ad­vanced ther­a­pies.

Af­ter found­ing the biotech Bi­o­Lam­i­na, Kris­t­ian Tryg­gva­son launched his lat­est ven­ture called Alder Ther­a­peu­tics. The com­pa­ny has now agreed to help NorthX ex­pand its cell cul­ture ser­vices to many new dif­fer­ent cell types, in­clud­ing pluripo­tent stem cells. The Alder team will al­so help to de­sign and val­i­date NorthX’s new process de­vel­op­ment and GMP-man­u­fac­tur­ing labs in Mat­fors and Stock­holm.

“This ex­pan­sion in­to cell ther­a­py is a ma­jor step to com­plet­ing our of­fer­ing for in­no­v­a­tive clients. We are es­pe­cial­ly ex­cit­ed to work with Dr. Kris­t­ian Tryg­gva­son, a leader in cell ther­a­py tech­nolo­gies, and his team,” said Ted Fjäll­man, CEO of NorthX.

Bay Area Biotech launch­es new man­u­fac­tur­ing cen­ter for ge­net­ic med­i­cines

Tenaya Ther­a­peu­tics is forg­ing ahead in the com­pet­i­tive field of gene ther­a­py pro­duc­tion.

The com­pa­ny has fin­ished the build-out of its Ge­net­ic Med­i­cines Man­u­fac­tur­ing Cen­ter in Union City, Cal­i­for­nia. Tenaya is look­ing to ad­vance a pipeline of ther­a­peu­tic can­di­dates, in­clud­ing sev­er­al AAV gene ther­a­pies, for the po­ten­tial treat­ment of both rare and preva­lent forms of heart dis­ease.

“The op­er­a­tional launch of Tenaya’s Ge­net­ic Med­i­cines Man­u­fac­tur­ing Cen­ter rep­re­sents an im­por­tant mile­stone as we pre­pare to ad­vance our ro­bust pipeline of po­ten­tial­ly first-in-class car­dio­vas­cu­lar ther­a­pies in­to ini­tial clin­i­cal stud­ies,” said Tenaya CEO Faraz Ali.

The 94,000-square-foot fa­cil­i­ty has man­u­fac­tur­ing suites and labs, of­fice space and stor­age and is now ful­ly op­er­a­tional with the ini­tial ca­pac­i­ty to pro­duce AAV-based gene ther­a­pies at the 1000L scale. The new lo­ca­tion is al­so de­signed to meet reg­u­la­to­ry re­quire­ments for the pro­duc­tion of AAV gene ther­a­pies.

Ac­cord­ing to the com­pa­ny, their ini­tial pro­duc­tion ef­forts will sup­port first-in-hu­man stud­ies of its lead gene ther­a­py, TN-201.

The can­di­date is be­ing de­vel­oped for the treat­ment of ge­net­ic hy­per­trophic car­diomy­opa­thy (HCM). The com­pa­ny plans to sub­mit an IND to the FDA in the sec­ond half of this year. The fa­cil­i­ty will al­so sup­port the pro­duc­tion of TN-401, its gene ther­a­py pro­gram be­ing de­vel­oped for the treat­ment of ge­net­ic ar­rhyth­mo­genic right ven­tric­u­lar car­diomy­opa­thy (ARVC), which will go to the FDA in 2023.

The com­pa­ny, af­ter re­ceiv­ing a siz­able $106 mil­lion Se­ries C in 2021, went pub­lic in the mid­dle of last year. How­ev­er, it has been feel­ing the bite of the bear mar­ket as its stock is down $TNYA 68% since the be­gin­ning of the year.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

One of Sanofi CEO Paul Hudson’s top picks in the pipeline — picked up in a $3.7 billion buyout 2 years ago — has just been sidelined in the US by a safety issue.

The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.

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Phar­ma re­acts to post-Roe; Drug­mak­ers beef up cy­ber de­fense; Boehringer, Roche qui­et­ly axe drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As a reminder, we are off on Monday for the Fourth of July. I hope this recap will kick off your (long) weekend well and that the rest of it will be just what you need. See you next week for a shortened edition!

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Eric Hughes, incoming Teva EVP of global R&D and CMO

Te­va chief raids Ver­tex for his new glob­al head of re­search and de­vel­op­ment

Teva CEO Kåre Schultz has found his new R&D chief and CMO in Vertex’s ranks.

The global generics giant, which has some 3,500 staffers in the R&D group, has named Eric Hughes to the top research spot in the company. He’ll be replacing Hafrun Fridriksdottir, who held the role for close to five years, on Aug. 1.

Hughes hasn’t been at Vertex for long, though. He jumped from Novartis less than a year ago, after heading the immunology, hepatology & dermatology global development unit. Before that, he completed a five-year stint as head of early clinical research for the specialty discovery medicine department in the exploratory clinical & translational research group at Bristol Myers Squibb, according to his LinkedIn profile.

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#BIO22: Man­ag­ing a biotech in tur­bu­lent times. 'There's a per­fect shit­show out there'

On Tuesday, June 14, Endpoints News EIC John Carroll sat down with a group of biotech execs to discuss the bear market for industry stocks and how they were dealing with it. Here’s the conversation, which has been lightly edited for brevity.

Martin Meeson, sponsor opening:

Thank you, John. Hello everyone. My name’s Martin Meeson, I’m the CEO of Fujifilm Diosynth. For those of you who don’t know Fujifilm Diosynth, we operate in the development of clinical and commercial product scale up, we have facilities in Europe and the US, and around about 4,000 employees. We run on average about 150 programs, so when it comes to managing in turbulent times over the last two years, we’ve had quite a lot of experience of that. Not just keeping the clinical pipelines and the commercial pipelines open, but also our response to the pandemic and the molecules that we’ve had within there. One of the phrases that I coined probably about a year ago when we were talking at JP Morgan, was I talked about managing through turbulent times. Well, it’s become the fact that we are not managing and leading through these times, we are managing in them, which is why that’s really the purpose of and the topic that we’ve got today.

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On Friday, Lonza announced plans to construct a large-scale commercial drug product fill and finish facility in the town of Stein, Switzerland.

Lon­za to in­vest $500M+ on fill-fin­ish fa­cil­i­ty on its home turf

Lonza has been expanding its reach across the globe, bringing sites in China and the US online this year, but now they are looking closer to home for their next major investment.

The Swiss manufacturer on Friday announced plans to construct a large-scale commercial drug fill and finish facility in the town of Stein, Switzerland. The new facility will be delivered through an investment of approximately CHF 500 million, or $519 million, and is expected to be completed in 2026. The facility will also be constructed on the same campus as Lonza’s current clinical drug product facility.

Emer Cooke, ICRMA chair (AP Photo/Geert Vanden Wijngaert)

ICM­RA to launch sev­er­al reg­u­la­to­ry pi­lot pro­grams cen­tered around man­u­fac­tur­ing in­spec­tions

As regulatory agencies look to catch up on inspections amid the Covid-19 pandemic, ICMRA is unveiling several pilot programs to address industry applications and inspections.

ICMRA, which is made up of the world’s top drug regulators, is launching multiple pilot programs, including two regulatory pilots addressing facility inspections for chemistry and manufacturing controls (CMC) and post-approval change (PAC) submission assessments and related regulatory actions.

Man­u­fac­tur­ing roundup: Teru­mo BCT part­ners with Bio­Bridge sub­sidiary to man­u­fac­ture cell and gene ther­a­pies; WuXi STA opens plant for HPA­PI pro­duc­tion

As the manufacturing of cell and gene therapies is ramping up and companies are starting to invest in their manufacturing capabilities, Terumo Blood and Cell Technologies have formed a partnership to stay in the game.

According to the company, it has signed a new collaborative agreement with GenCure, a subsidiary of BioBridge Global, to extend and unify cell and gene therapy manufacturing solutions.

No­var­tis to re­sume the pro­duc­tion of two ra­di­oli­gand ther­a­pies af­ter re­solv­ing qual­i­ty is­sues

Earlier this year, Novartis touted its radioligand as a major piece to counter competition in the cancer space. However, the physical production of its products has had anything but a smooth ride.

In May, Novartis had to suspend production of Lutathera and Pluvicto, its two primary radiotherapies. According to the company, this was done out of an abundance of caution as a result of potential quality issues identified in its manufacturing. The production suspension impacts the commercial and clinical trial supply of the products.

FDA slaps warn­ing let­ter on Min­neso­ta API fa­cil­i­ty af­ter em­ploy­ee de­stroys clean­ing log

A manufacturing facility belonging to the Netherlands-based API producer Fagron Group has entered the FDA’s crosshairs after an employee destroyed a cleaning log, among other violations.

One of its plants in Saint Paul, MN received a warning letter on June 14, following an inspection last November that uncovered cross-contamination concerns.

“In your response, you provided a follow-up cleaning validation report in which you only assessed the carryover of niacin swab samples but not progesterone, which was included in your initial cleaning validation,” FDA says in the letter. “The lack of progesterone (b)(4) [commercially confidential information] is concerning considering the failing residue results you provided to investigators would yield unacceptable levels of progesterone cross-contamination.”