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.

Ac­cord­ing to Lon­za, this in­vest­ment will en­able the com­pa­ny to pro­vide an end-to-end ca­pa­bil­i­ty for com­mer­cial drug prod­uct man­u­fac­tur­ing at a large-scale mar­ket sup­ply, with a va­ri­ety of phar­ma­ceu­ti­cal prod­ucts be­ing pro­duced at the fa­cil­i­ty in dif­fer­ent com­mer­cial for­mats.

Lon­za did not con­firm the ex­act size of the fa­cil­i­ty to End­points News. 

Pierre-Alain Ruffieux

“This strate­gic in­vest­ment com­pletes our of­fer­ing in drug prod­ucts and strength­ens our po­si­tion as a lead­ing CD­MO with an un­par­al­leled breadth of of­fer­ings across scales and tech­nolo­gies,” said Lon­za CEO Pierre-Alain Ruffieux, in a state­ment.

In an email to End­points News, the com­pa­ny said it sees strong de­mand for com­mer­cial fill-fin­ish and the new fa­cil­i­ty will en­able it to ad­dress this de­mand and of­fer an in­te­grat­ed drug sup­ply chain so­lu­tion across the en­tire life cy­cle.

Since es­tab­lish­ing drug prod­uct de­vel­op­ment and man­u­fac­tur­ing ser­vices in 2016, Lon­za has ex­pand­ed man­u­fac­tur­ing at three sites in Switzer­land in­clud­ing Basel, Stein and Visp, as well as a site in Guangzhou, Chi­na.

Lon­za has al­so been on the March in oth­er man­u­fac­tur­ing ar­eas as well. In March, the CD­MO fin­ished con­struc­tion on their API de­vel­op­ment and man­u­fac­tur­ing labs at a site in Nan­sha, Chi­na. This move was fo­cused on ex­tend­ing the ca­pa­bil­i­ties of high po­ten­cy APIs, and ex­pand­ed man­u­fac­tur­ing space to en­sure that clin­i­cal sup­ply lev­els could meet de­mand.

Ear­li­er this month, Lon­za al­so ex­pand­ed its fa­cil­i­ty in Bend, Ore­gon to man­u­fac­ture small mol­e­cules and serve as the com­pa­ny’s cen­ter of ex­cel­lence for bioavail­abil­i­ty en­hance­ment and in­haled de­liv­ery for its small mol­e­cules busi­ness unit.

How­ev­er, Lon­za is find­ing it­self in an ever-busy home man­u­fac­tur­ing mar­ket. Com­peti­tors have been turn­ing to Lon­za’s back­yard over the past year as com­pa­nies such as Cy­ti­va, Ther­mo Fish­er and lo­cal up­starts ten23 have all been build­ing or ex­pand­ing their sites in Switzer­land over the past year.

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.

Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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Sar­to­rius to ac­quire French man­u­fac­tur­er for $2.6B+ in cell and gene ther­a­py play

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.

CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

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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Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

TScan Therapeutics' departing CEO David Southwell and CSO/COO Gavin MacBeath

TCR up­start an­nounces CEO ex­it, with CSO now act­ing re­place­ment

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.

Austin biotech Mol­e­c­u­lar Tem­plates lays off more than 100 staffers as pipeline nar­rows

Molecular Templates is ridding itself of a Phase I HER2 asset and fine-tuning its pipeline to focus on three programs and a preclinical Bristol Myers Squibb collaboration. With the narrowed scope on its so-called engineered toxin bodies, the Austin, TX biotech is laying off about half of its staff.

That’s a little more than 100 employees, per an SEC filing. Molecular’s layoffs, approved by its board Wednesday, add to the dozens of pullbacks in the industry in the first three months of 2023.

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