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.

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

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Paul Perreault, CSL Behring CEO

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

The FDA has approved the world’s first gene therapy for hemophilia B, ushering into the market a treatment that’s historic in both what it promises to do and how much it will cost.

CSL will be marketing the drug, Hemgenix, at a list price of $3.5 million — which sets a new record for the most expensive single-use gene therapy in the US.

In a statement provided to Endpoints News, the Australian company noted that the current costs of treating people with moderate to severe hemophilia B can be significant over a lifetime. By some estimates, healthcare systems could spend more than $20 million per person.

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Image: Shutterstock

MIT re­searchers re­veal DNA "Paste" tech be­hind lat­est gene edit­ing start­up

MIT scientists have developed a tool that they say can insert large gene sequences where they want in the genome.

In a paper published Thursday in Nature Biotechnology, MIT fellows Omar Abudayyeh, Jonathan Gootenberg and colleagues detail a technology they call PASTE, which they say can potentially be used to insert long strands of DNA and treat genetic diseases caused by many different mutations, such as cystic fibrosis and Leber congenital amaurosis, a rare eye disorder that causes blindness.

Elon Musk (GDA via AP Images)

Biggest drug com­pa­nies halt­ed Twit­ter ad buys af­ter Lil­ly in­sulin spoof

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

Rob Davis, Merck CEO

Up­dat­ed: No Seagen here: 'Do more' means a small $1.35B pur­chase of Ima­go for Mer­ck

Merck is making an acquisition, the Big Pharma announced before Monday’s opening bell. No, Seagen is not entering the fold, as had been speculated for quarters.

Folding under Merck’s wings will be Pfizer-backed Imago BioSciences. For nearly a year, Merck CEO Rob Davis has been saying the pharma giant needs to “do more” on the business development front after its 2021 $11.5 billion acquisition of Acceleron.

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Fu­ji­film to build $188M man­u­fac­tur­ing plant in North Car­oli­na’s re­search tri­an­gle

As the Japanese conglomerate Fujifilm continues to invest heavily in its CDMO arm, one of its manufacturing divisions is teeing up a major investment.

Fujifilm Irvine Scientific announced on Tuesday that parent Fujifilm is making a $188 million investment to build a cell culture media manufacturing site in the Research Triangle Park in North Carolina. The new site will mark Fujifilm Irvine’s fifth manufacturing site globally and its second in the US.

J&J's Spra­va­to pulls a PhI­II win against Sero­quel XR in treat­ment-re­sis­tant de­pres­sion

A day before Thanksgiving, J&J’s Janssen has a new cut of Phase III Spravato data to be grateful for.

The pharma giant announced on Wednesday that its nasal spray, also known as esketamine, beat extended-release quetiapine, previously sold by AstraZeneca as Seroquel XR, in treatment-resistant depression (TRD). Of 676 adults, a significantly higher number of patients on Spravato were able to achieve remission and avoid relapse after 32 weeks, according to J&J.

Sus­pend­ed Cal­i­for­nia cell ther­a­py man­u­fac­tur­ing site hit with FDA warn­ing let­ter over ma­jor qual­i­ty con­cerns

A cell therapy outfit in California that manufactures a human umbilical cord derived cellular product and exosome products is facing a warning from the FDA over several major observations related to quality.

The FDA notes the site’s “deficient donor screening practices, inadequate aseptic practices, unvalidated manufacturing,” and the “risk that your products may be contaminated with microorganisms or have other serious product quality defects.”

Dermavant Sciences' first consumer TV ad for its Vtama psoriasis med shows people ready for a new topical treatment.

Roivant’s Der­ma­vant de­buts first-ever TV com­mer­cial for pso­ri­a­sis cream Vta­ma

Dermavant Sciences has been marketing its first product, psoriasis med Vtama, to dermatologists for months, but on Tuesday it rolled out its first consumer campaign. The debut DTC effort including a streaming TV commercial encourages patients to a “Topical Uprising” in a nod to Vtama being a topical cream.

In the new commercial, a swell of people discards scarves and jacket coverings, gathering in the street to converge on a pharmacy to demand a steroid-free prescription. A moment of levity follows when a pharmacist says, “You know you can just talk to your doctor, right?” The gathered crowds collectively says, “Oh.”

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