Man­u­fac­tur­ing roundup: Avid Bioser­vices ex­pands in Cal­i­for­nia; Charles Riv­er nets cell ther­a­py pro­duc­tion deal

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.

Charles Riv­er inks deal to man­u­fac­ture gene ther­a­py with ASC Ther­a­peu­tics

Mass­a­chu­setts-based Charles Riv­er Lab­o­ra­to­ries and ASC Ther­a­peu­tics, a pri­vate­ly held bio­phar­ma that spe­cial­izes in gene ther­a­pies, have agreed to man­u­fac­ture ASC618, a gene ther­a­py for he­mo­phil­ia A.

Fi­nan­cial de­tails and a time­line of the arrange­ment were not dis­closed.

Ker­stin Dolph, SVP for bi­o­log­ics so­lu­tions man­age­ment at Charles Riv­er, said that the com­pa­ny has been work­ing with ASC since 2019, to help es­tab­lish a man­u­fac­tur­ing process for their pre­clin­i­cal re­search. To­geth­er both com­pa­nies have es­tab­lished a process for AAV8 pro­duc­tion.

Dolph al­so said that the plas­mid man­u­fac­tur­ing and test­ing, GMP-up­stream and -down­stream process­es, and the fill/fin­ish for ASC are hap­pen­ing at their fa­cil­i­ty in Rockville, MD.

BioCi­na opens new DNA man­u­fac­tur­ing site

Af­ter ac­quir­ing Pfiz­er-owned Hos­pi­ra Ade­laide, the San Diego CD­MO BioCi­na has ex­pand­ed its ser­vice of­fer­ings to in­clude the man­u­fac­ture of plas­mid DNA (pDNA) in a new GMP suite.

While no fi­nan­cial or size de­tails were pre­sent­ed, the suite is now open and has up to 300 L sin­gle-use fer­men­ta­tion ca­pac­i­ty and scaled down­stream pro­cess­ing equip­ment to com­ple­ment their man­u­fac­tur­ing ca­pa­bil­i­ties.

“With our ex­treme­ly strong his­to­ry of qual­i­ty in man­u­fac­tur­ing, an ex­em­plary reg­u­la­to­ry in­spec­tion his­to­ry, and our cus­tomer-cen­tric busi­ness ap­proach, BioCi­na is in a strong po­si­tion to add sig­nif­i­cant val­ue to com­pa­nies work­ing in the RNA and gene and cell ther­a­py space that are strug­gling to find re­li­able and col­lab­o­ra­tive out­sourc­ing part­ners,” said BioCi­na CEO Ian Wisen­berg.

Ac­cord­ing to the com­pa­ny, its de­ci­sion to ex­pand its ser­vice of­fer­ing in­to pDNA de­vel­op­ment and man­u­fac­tur­ing was dri­ven by the de­mand for GMP-grade pDNA.

Eu­ro­pean-based man­u­fac­tur­ers come to­geth­er for an­ti­body drug pro­duc­tion

Swiss drug man­u­fac­tur­er Lon­za and French phar­ma­ceu­ti­cal group Pierre Fab­re an­nounced on Wednes­day that the com­pa­nies have en­tered in­to a man­u­fac­tur­ing agree­ment.

While no fi­nan­cial de­tails were re­vealed, the col­lab­o­ra­tion will be cen­tered around man­u­fac­tur­ing W0180, a mon­o­clon­al an­ti­body dis­cov­ered by Pierre Fab­re tar­get­ing the VISTA check­point. The as­set is be­ing in­ves­ti­gat­ed as a sin­gle agent and in com­bi­na­tion with pem­brolizum­ab in Phase I clin­i­cal tri­al in var­i­ous sol­id can­cer tu­mors.

The deal will have Lon­za pro­vide cGMP drug prod­uct man­u­fac­tur­ing ser­vices for clin­i­cal sup­ply from its fill and fin­ish fa­cil­i­ty in Stein, Switzer­land.

Lon­za has been on the move across the globe re­cent­ly, as it has not on­ly re­cent­ly col­lab­o­rat­ed with a VC in Is­rael, but has al­so com­plet­ed a man­u­fac­tur­ing fa­cil­i­ty in Bend, Ore­gon.

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.”