Man­u­fac­tur­ing roundup: Gen­Sight ter­mi­nates batch of gene ther­a­py; Evonik opens lipid pro­duc­tion site in Ger­many

Gen­Sight Bi­o­log­ics’ gene ther­a­py treat­ment for Leber hered­i­tary op­tic neu­ropa­thy, called Lumevoq, had an op­er­a­tional is­sue oc­cur dur­ing the man­u­fac­tur­ing process for one of its batch­es.

In a re­lease, the gene ther­a­py biotech stat­ed that the op­er­a­tional is­sue oc­curred in the down­stream process lead­ing to the ter­mi­na­tion of the batch. The root cause is now be­ing in­ves­ti­gat­ed in col­lab­o­ra­tion with Ther­mo Fish­er Sci­en­tif­ic, as its sub­sidiary, Bram­mer Bio, is its man­u­fac­tur­ing part­ner in the US.

To try and pre­vent this is­sue from oc­cur­ring again, both par­ties have agreed to in­volve Gen­Sight’s ex­perts with the team at Bram­mer Bio, which will in­clude a per­son from Gen­Sight be­ing in the plant at all times.

“Even if lim­it­ed, I deeply re­gret this ad­di­tion­al de­lay. How­ev­er, giv­en the suc­cess­ful pro­duc­tion of two suc­ces­sive en­gi­neer­ing batch­es un­der the help and su­per­vi­sion of Gen­Sight’s ex­perts, we are con­fi­dent that the mea­sures be­ing joint­ly im­ple­ment­ed with our man­u­fac­tur­ing part­ner will lead to a suc­cess­ful val­i­da­tion cam­paign,” said Bernard Gilly, Gen­Sight Bi­o­log­ics CEO in a re­lease.

Evonik opens a lipid man­u­fac­tur­ing site

The Ger­man chem­i­cal man­u­fac­tur­er Evonik is open­ing the doors to a new fa­cil­i­ty to strength­en its po­si­tion in the man­u­fac­tur­ing of lipids.

Evonik has opened a man­u­fac­tur­ing fa­cil­i­ty at its site in the town of Hanau, Ger­many, to pro­duce lipids for phar­ma­ceu­ti­cal clients. The site of­fi­cial­ly opened on Wednes­day.

The lipids be­ing pro­duced in Hanau plan to serve cus­tomers work­ing in the RNA and gene ther­a­py space as well as those work­ing with in­fec­tious dis­eases, pro­tein re­place­ment ther­a­py or can­cer ther­a­pies. How­ev­er, de­tails on the size or the scale of pro­duc­tion were not im­me­di­ate­ly avail­able to End­points News.

“Our of­fer­ing al­lows cus­tomers to ob­tain high-qual­i­ty GMP ma­te­r­i­al con­sis­tent with larg­er scale pro­duc­tion, en­abling a seam­less path for scale-up – al­low­ing our part­ners to move quick­ly in this fast-paced de­vel­op­ment space,” Paul Spencer, head of drug de­liv­ery and prod­ucts at Evonik’s health­care busi­ness, said in a re­lease.

Evonik has been build­ing its pres­ence in the lipid field as last year it an­nounced plans to build a new, $22o mil­lion lipid pro­duc­tion fa­cil­i­ty in Lafayette, IN.

Pi­ra­mal hand­ed FDA in­spec­tion re­port

A man­u­fac­tur­er have been giv­en a 483 in­spec­tion re­port from the FDA.

One in­spec­tion at Pi­ra­mal Phar­ma So­lu­tion’s man­u­fac­tur­ing site in Lex­ing­ton, KY, re­vealed six ma­jor ob­ser­va­tions in its re­port. The re­port was giv­en to End­points News via a FOIA re­quest to the FDA.

The in­spec­tion, which took place be­tween late De­cem­ber of last year and ear­ly Jan­u­ary 2023, found sev­er­al pro­ce­dures not be­ing fol­lowed, in­clud­ing an in­te­ri­or air­lock door be­ing open, a fail­ure to fol­low stan­dard op­er­at­ing prac­tices and steril­i­ty test­ing of the prod­uct be­ing re­leased with­out re­view.

The FDA al­so found de­vi­a­tions from test­ing pro­ce­dures and a hose that is used in a wash­room that had no clean­ing iden­ti­ty. In­spec­tors al­so not­ed that sev­er­al log­books were in­com­plete or miss­ing ini­tials from peo­ple who ini­ti­at­ed the tests.

End­points News reached out to Pi­ra­mal, but did not get a re­sponse by press time.

For­mu­lat­ed So­lu­tions in­vest­ing close to $44M in Ten­nessee

Man­u­fac­tur­er For­mu­lat­ed So­lu­tions will be mak­ing a $43.6 mil­lion in­vest­ment in­to its op­er­a­tions in south­ern Ten­nessee.

Ac­cord­ing to a re­lease from the Ten­nessee gov­er­nor’s of­fice, For­mu­lat­ed So­lu­tions will be cre­at­ed around 524 jobs at its 455,000-square-foot fa­cil­i­ty in Cleve­land, TN. The Flori­da-based man­u­fac­tur­er ac­quired the site in De­cem­ber of last year and has been in op­er­a­tion for over 40 years.

For­mu­lat­ed So­lu­tion pro­duces over-the-counter prod­ucts as well as de­vices and pre­scrip­tion drug prod­ucts. Once op­er­a­tional, the site will al­so be the man­u­fac­tur­er’s first pro­duc­tion site out­side of Flori­da.

Dana­her part­ners up with the Uni­ver­si­ty of Penn­syl­va­nia

Life sci­ence gi­ant Dana­her is en­ter­ing in­to a mul­ti-year strate­gic part­ner­ship with the Uni­ver­si­ty of Penn­syl­va­nia to de­vel­op new tech­nolo­gies to try and over­come man­u­fac­tur­ing “bot­tle­necks” in the pro­duc­tion of cell ther­a­py prod­ucts.

The pro­gram, which is part of Dana­her’s pro­gram to fund sci­en­tif­ic re­search in aca­d­e­m­ic set­tings, the ob­jec­tive of the pro­gram is to de­vel­op tech­nolo­gies and ap­pli­ca­tions to im­prove health. The fo­cus for Penn will be on so­lu­tions to bot­tle­necks that can im­pact the man­u­fac­tur­ing yield and qual­i­ty of cell ther­a­pies.

The work at the uni­ver­si­ty will be led by Joseph Frai­et­ta, as­sis­tant pro­fes­sor of mi­cro­bi­ol­o­gy, along with Saar Gill, as­so­ciate pro­fes­sor of hema­tol­ogy-on­col­o­gy; Friederike Herb­st-Nowrouzi, di­rec­tor of the hu­man genome edit­ing lab­o­ra­to­ry and Megan Suhos­ki, di­rec­tor of the prod­uct de­vel­op­ment lab­o­ra­to­ry.

All of the prin­ci­pal in­ves­ti­ga­tors on the projects are part of the Cen­ter for Cel­lu­lar Im­munother­a­pies, led by Carl June.

“We are de­light­ed to be part­ner­ing with the CAR T pi­o­neers at Penn and be­lieve that com­bin­ing our ex­per­tise in sci­ence and tech­nol­o­gy will help bring the next gen­er­a­tion of cell ther­a­pies to pa­tients faster,” said Vanes­sa Al­men­dro, VP of sci­ence and tech­nol­o­gy at Dana­her, in a state­ment.

Sim­ris Alg AB en­ters an agree­ment with Lon­za to com­mer­cial­ize its plat­form

The Swe­den-based bi­o­log­ics com­pa­ny Sim­ris Alg AB had en­tered a col­lab­o­ra­tion agree­ment with the Swiss CD­MO Lon­za to com­mer­cial­ize Sim­ris’s ADC plat­form.

The terms of the deal will have Lon­za in­te­grate Sim­ris’ ADC tech­nol­o­gy and get the ex­clu­sive rights to of­fer the tech to any new or ex­ist­ing cus­tomers. In re­turn, Sim­ris will pro­mote Lon­za to cus­tomers as its ex­clu­sive CD­MO part­ner.

The fi­nan­cial terms of the deal were not dis­closed.

“This strate­gic part­ner­ship will help Sim­ris to reach new cus­tomers and Lon­za’s mar­ket-lead­ing ca­pa­bil­i­ties as a CD­MO in­crease the like­li­hood that our pay­loads will reach clin­i­cal use and there­by im­prove life qual­i­ty for those un­for­tu­nate enough to suf­fer from can­cer,” said Sim­ris CEO Ju­lian Read, in a state­ment.

Catal­ent ap­points Srid­har Kr­ish­nan to a new po­si­tion

The CD­MO Catal­ent has named Srid­har Kr­ish­nan to a new­ly cre­at­ed po­si­tion at the com­pa­ny.

Kr­ish­nan will be the VP of The Catal­ent Way, where he will lead the CD­MO’s “op­er­a­tional ex­cel­lence strat­e­gy” and as­sist with growth and im­ple­ment­ing “lean prin­ci­ples” at the com­pa­ny. He will al­so be on the ex­ec­u­tive lead­er­ship team and re­port di­rect­ly to CEO Alessan­dro Masel­li.

The Catal­ent way, ac­cord­ing to the com­pa­ny, is a sys­tem of im­prove­ments at the com­pa­ny that is de­signed to en­act more ef­fi­cient process­es. No wider de­tails were im­me­di­ate­ly avail­able.

Kr­ish­nan him­self is re­turn­ing to Catal­ent af­ter serv­ing as the SVP and head of op­er­a­tions at Ju­bi­lant Phar­ma. He has 20 years of lead­er­ship ex­pe­ri­ence in the CD­MO space, in­clud­ing sev­er­al VP po­si­tions at Catal­ent.

“Srid­har brings con­sid­er­able op­er­a­tional lead­er­ship and Lean ex­per­tise, as well as a proven track record dri­ving en­ter­prise-wide busi­ness trans­for­ma­tions and op­er­a­tional per­for­mance. We wel­come him back to Catal­ent, in a role where he will pro­vide the key strate­gic fo­cus nec­es­sary to not on­ly es­tab­lish new stan­dards of ex­cel­lence at Catal­ent but with­in the phar­ma­ceu­ti­cal in­dus­try,” Masel­li said in a re­lease.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Alec­tor cuts 11% of work­force as it dou­bles down on late-stage neu­ro pro­grams part­nered with GSK, Ab­b­Vie

A month after revealing plans to concentrate on its late-stage immuno-neurology pipeline, Alector is trimming its headcount by 11%.

The layoffs will impact around 30 employees across the organization, the company disclosed in an SEC filing, adding that the plan will “better align the company’s resources” with the new strategy. With $712.9 million in cash, cash equivalents and investments as of the end of 2022, Alector believes the reserves will now get it through 2025.

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Hugo Peris, Spiral Therapeutics CEO

Hear­ing-fo­cused biotech grabs trio of pro­grams from Oton­o­my's fire sale

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

UK gov­ern­ment, pri­vate in­vestors dole out $340M+ to drug, di­ag­nos­tic man­u­fac­tur­ers

The government of the United Kingdom is giving out grants to several manufacturers that have a presence in England, Wales and Northern Ireland.

The government announced that four companies, including Ipsen, contract manufacturer Pharmaron, DNA manufacturer Touchlight and diagnostic test producer Randox, will receive a total of £277 million ($341.1 million). According to a release from the UK government, this represents the first portion of grants from the Life Sciences Innovative Manufacturing Fund.

Phar­maron ex­pand­ing Liv­er­pool man­u­fac­tur­ing fa­cil­i­ty with a $186M+ price tag

Liverpool may be known for rock and roll and premier league football, but the China-based contract manufacturer Pharmaron is looking to make it a bigger hub for cell and gene therapy manufacturing.

As part of Pharmaron’s further commitment to Merseyside county, it plans to build an 8,000-square-meter facility, or around 86,000 square feet, which includes a boost to the manufacturing capacity of 3,500 square meters, or 37,600 square feet. The price tag for the expansion will be £151 million ($186 million), with Pharmaron receiving a grant from the UK Government’s Life Sciences Innovation Manufacturing Fund (LSIMF).