Man­u­fac­tur­ing roundup: Catal­ent caps off man­u­fac­tur­ing site in Bel­gium; Eu­roAPI restarts pro­duc­tion in Hun­gary

Catal­ent is open­ing the doors to a new plas­mid DNA man­u­fac­tur­ing site at one of its core sites in Eu­rope.

The new 12,000-square-foot plas­mid man­u­fac­tur­ing site is lo­cat­ed in its cell ther­a­py cen­ter in Gos­selies, Bel­gium, and has mul­ti­ple clean­rooms meant to pro­duce cGMP-grade plas­mid DNA for clin­i­cal and com­mer­cial pur­pos­es. The site will al­so see Catal­ent pro­duc­ing plas­mids that are in­tend­ed to be used by cell and gene com­pa­nies.

“Plas­mid DNA is a crit­i­cal com­po­nent to many bi­o­log­i­cal ther­a­peu­tics, and Catal­ent has made this in­vest­ment in ad­di­tion­al man­u­fac­tur­ing ca­pac­i­ty in an­tic­i­pa­tion of sup­port­ing the grow­ing num­ber of pro­grams through de­vel­op­ment to­wards com­mer­cial­iza­tion,” said Man­ja Boer­man, Catal­ent’s pres­i­dent for bio­modal­i­ties, in a re­lease.

Eu­roAPI re­sumes prostaglandin pro­duc­tion in Hun­gary

The Sanofi spin­off Eu­roAPI has restart­ed the man­u­fac­tur­ing of prostaglandin at its site in Bu­dapest, Hun­gary.

In De­cem­ber, Eu­roAPI said in a re­lease that it had dis­cov­ered GMP short­falls re­lat­ed to doc­u­ments dur­ing an in­ter­nal as­sess­ment and de­cid­ed to sus­pend the man­u­fac­tur­ing of prostaglandin at its Bu­dapest site. Since then, Eu­roAPI said that it has put in a plan to make cor­rec­tions which al­lowed the man­u­fac­tur­er to restart pro­duc­tion in Jan­u­ary. Eu­roAPI stat­ed that it ex­pects the bulk of prostaglandin pro­duc­tion to be back on­line by the mid­dle of April.

Eu­roAPI al­so stat­ed that no oth­er ac­tiv­i­ties at the site were im­pact­ed by the sus­pen­sion.

Car­bo­gen Am­cis opens new fa­cil­i­ty in France

Car­bo­gen Am­cis has opened a new site for man­u­fac­tur­ing in­jectable drugs has opened in Saint-Beauzire, France.

The new man­u­fac­tur­ing site, which is not from an ex­ist­ing Car­bo­gen Am­cis fa­cil­i­ty, plans to boost the de­vel­op­ment and pro­duc­tion of liq­uid and freeze-dried prod­ucts that are for clin­i­cal tri­als and small-scale com­mer­cial ac­tiv­i­ty.

Con­struc­tion on the 9,500 square me­ters fa­cil­i­ty it­self start­ed in Jan­u­ary of 2021 and has two pro­duc­tion lines. The site will have a head­count of around 100, with Car­bo­gen Am­cis plan­ning to cre­ate 50 jobs through­out the year.

“Over the last six years, CAR­BO­GEN AM­CIS has con­tin­ued to ex­pand our fa­cil­i­ties and grow our ca­pac­i­ty, en­abling us to sup­port more cus­tomers and in­crease ac­cess to new and di­verse tech­nolo­gies and ser­vices,” said CEO Pas­cal Ville­magne in a re­lease emailed to End­points News.

Pa­sithea Ther­a­peu­tics inks deal with WuXi STA to man­u­fac­ture in­gre­di­ent for its can­di­date

The Flori­da-based biotech Pa­sithea Ther­a­peu­tics has net­ted a man­u­fac­tur­ing con­tract with WuXi STA for the CD­MO to pro­duce the ac­tive phar­ma­ceu­ti­cal in­gre­di­ent (API) for its MEK in­hibitor dubbed PAS-004.

Pa­sithea said in a re­lease that it plans to sub­mit an IND to the FDA some­time in the lat­ter half of this year and is get­ting the ma­te­ri­als to make progress on the drug.

“WuXi STA has a proven track record of man­u­fac­tur­ing suc­cess to FDA stan­dards, and we be­lieve that their high-qual­i­ty ca­pa­bil­i­ties will sup­port the pro­gres­sion of our drug can­di­date in­to the clin­ic. PAS-004 has al­ready re­ceived or­phan drug des­ig­na­tion from the FDA for neu­rofi­bro­mato­sis 1, and we plan to start our phase 1 clin­i­cal tri­al in the sec­ond half of 2023,” stat­ed Graeme Cur­rie, chief de­vel­op­ment of­fi­cer of Pa­sithea, in a state­ment.

In­gre­di­ent man­u­fac­tur­er opens R&D cen­ter out­side of Boston

The ac­tive phar­ma­ceu­ti­cal in­gre­di­ent man­u­fac­tur­er Se­qens Group has opened the doors to a new 15,000-square-foot R&D cen­ter in the Boston sub­urb of De­vens, MA.

Ac­cord­ing to Se­qens, it placed a $5 mil­lion in­vest­ment in­to the fa­cil­i­ty and will re­place a small­er fa­cil­i­ty it has in De­vens. The man­u­fac­tur­er al­so plans to dou­ble the head­count of sci­en­tists at the lo­ca­tion by 2026. The site plans to boost the de­vel­op­ment of APIs and oth­er ma­te­ri­als, such as lipids that are used in RNA vac­cines.

The site will al­so serve as a ma­jor piece of its R&D net­work, which Se­qens has a to­tal of 10 across North Amer­i­ca and Eu­rope. Se­qens al­so has a man­u­fac­tur­ing fa­cil­i­ty in New­bury­port, MA.

“Every­thing starts with R&D. Tran­si­tion­ing our R&D cen­ter of ex­cel­lence to the new De­vens fa­cil­i­ty is an op­por­tu­ni­ty to con­tin­ue our ex­pan­sion in­to the U.S. mar­ket, with­in a state known as a vi­brant aca­d­e­m­ic hub, and sup­port our cus­tomers with in­te­grat­ed R&D ser­vices that set new bench­marks for in­no­va­tion, safe­ty, sus­tain­abil­i­ty and qual­i­ty,” said Pierre Luzeau, pres­i­dent and CEO of Se­qens Group, in a re­lease.

Re­Code Ther­a­peu­tics adds new SVP of qual­i­ty and reg af­fairs

The Ge­net­ic med­i­cine biotech Re­Code Ther­a­peu­tics has brought on a new SVP of qual­i­ty and chem­i­cal, man­u­fac­tur­ing and con­trols (CMC) reg­u­la­to­ry af­fairs.

April Loui has been brought on to over­see the reg­u­la­to­ry strate­gies for CMC and qual­i­ty for the com­pa­ny. Loui has over 25 years of ex­pe­ri­ence in the biotech and phar­ma world. Re­cent­ly she served as CEO and founder of Clar­i­ty Glob­al, which con­sult­ed life sci­ences com­pa­nies on best prac­tices for the de­vel­op­ment of com­mer­cial op­er­a­tions and guid­ing clients through com­pli­ance with health au­thor­i­ties.

Loui al­so served as the VP of qual­i­ty at Alec­tor and, be­fore that, was the se­nior di­rec­tor of CMC clin­i­cal qual­i­ty op­er­a­tion at Gilead Sci­ences. She al­so served as the head of qual­i­ty at Avid Bioser­vices.

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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Ivana Magovčević-Liebisch, Vigil Neuroscience CEO

FDA lifts par­tial clin­i­cal hold on Vig­il Neu­ro­science's TREM2 an­ti­body, re­mov­ing dos­ing cap

When Vigil Neuroscience filed its IPO papers in late 2021, the biotech revealed that the FDA had just cleared its Phase I trial — but with a partial clinical hold that limited dosing to under a certain level.

More than a year later, the FDA has lifted the hold.

Vigil is now free to dose VGL101, an antibody targeting TREM2, at levels higher than 20 mg/kg in its ongoing and future clinical trials in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), an inherited condition that affects the brain and spinal cord.

Cedric Ververken, Confo Therapeutics CEO

Dai­ichi Sankyo inks $183M dis­cov­ery deal with GPCR biotech for CNS tar­get

Belgian biotech Confo Therapeutics has landed $183 million, plus potential royalties, in a drug-discovery deal with Daiichi Sankyo.

Early Thursday, Confo Therapeutics put out word of the deal that will be focused on small molecule antagonists to go after an undisclosed target that the company says is associated with CNS diseases.

Confo CEO Cedric Ververken told Endpoints News that Daiichi originally reached out to learn about the biotech’s technology. He added that Confo, founded in 2015, will use its platform to drug a GPCR target that Daiichi has struggled with internally.

Dif­fu­sion to hand Nas­daq spot to EIP Phar­ma for PhI­Ib de­men­tia study of ex-Ver­tex drug

One of the more than a dozen bidders for Diffusion Pharmaceuticals’ spot on Nasdaq has prevailed.

Boston biotech EIP Pharma will merge with Diffusion in an all-stock deal, with plans to start a Phase IIb clinical trial in the coming months in a common form of dementia with no approved treatments. The combined company will be renamed CervoMed.

The nine-year-old privately-held EIP is working on a former Vertex drug that it will test in a 160-person Phase IIb in patients with dementia with Lewy bodies, or DLB. The National Institute on Aging is expected to fund that trial with a $21 million grant. With the reverse merger, slated for closing in the middle of this year, EIP will be funded through that readout in the second half of 2024. EIP’s equity and debt holders will own about 77.25% of the combined company.

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Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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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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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.