Amid a busy year and new lead­er­ship, Lon­za looks to build bio­con­ju­gates ca­pac­i­ty with Swiss ex­pan­sion set for 2022

Pierre-Alain Ruffieux

The year 2020 has been busy for con­tract man­u­fac­tur­ers, a trend which is hold­ing strong as an un­prece­dent­ed 12 months draw to a close. Swiss CD­MO Lon­za, one of the biggest play­ers in the field and un­der the re­cent lead­er­ship of Roche vet Pierre-Alain Ruffieux, has been at the fore­front of that out­sourc­ing boom, and now it’s look­ing to keep on grow­ing for what could be an even busier fu­ture.

Buoyed by deals to pro­duce 1 bil­lion world­wide dos­es of Mod­er­na’s Covid-19 vac­cine, Lon­za an­nounced an ex­pan­sion Mon­day that will in­crease its pro­duc­tion ca­pac­i­ty 30% by the first half of 2022.

Fo­cused on bio­con­ju­ga­tion—a process that can de­vel­op more com­plex pro­tein ther­a­peu­tics—Lon­za will add a rough­ly 16,100-square-foot ex­pan­sion to its fa­cil­i­ty in Visp, Switzer­land, for both clin­i­cal and com­mer­cial sup­ply. The com­pa­ny said it will al­so con­struct a 53,800-square-foot sup­port build­ing to in­crease stor­age and oth­er sup­port­ing in­fra­struc­ture, with the hope of mak­ing client work­flow more flex­i­ble and ef­fi­cient.

The cost of the ex­pan­sions was not pro­vid­ed.

Iwan Bertholjot­ti

“The lat­est in­vest­ment in ad­di­tion­al bio­con­ju­ga­tion de­vel­op­ment and man­u­fac­tur­ing ca­pac­i­ty is well aligned with oth­er cur­rent in­vest­ments in mon­o­clon­al an­ti­bod­ies and small mol­e­cules with­in the Lon­za net­work,” Iwan Bertholjot­ti, Lon­za’s di­rec­tor of com­mer­cial de­vel­op­ment bio­con­ju­gates, said in a press re­lease. “To­geth­er they fur­ther ex­tend our of­fer of a re­li­able and in­te­grat­ed sup­ply so­lu­tion for an ex­pand­ing class of in­no­v­a­tive ther­a­pies.”

Lon­za’s ex­pan­sion ef­forts come amid a year of change at the biotech. In June, af­ter an ex­tend­ed head­hunt­ing search, the com­pa­ny named for­mer Roche ex­ec­u­tive Pierre-Alain Ruffieux as CEO. Ruffieux paints him­self as a re-in­ven­tor of drug man­u­fac­tur­ing process­es, which seemed to fit what Lon­za was seek­ing — as it has re­cent­ly des­ig­nat­ed new growth ar­eas, in­vest­ed in new fa­cil­i­ties and re­vamp­ing a strug­gling spe­cial in­gre­di­ents di­vi­sion.

Since 2006, Lon­za has pro­duced over 600 cGMP batch­es of bio­con­ju­gat­ed prod­ucts for over 60 dif­fer­ent projects.

All signs point to Lon­za as a big play­er in the CD­MO are­na mov­ing for­ward. Just in De­cem­ber, for ex­am­ple, the com­pa­ny has an­nounced six dif­fer­ent man­u­fac­tur­ing and de­vel­op­ment col­lab­o­ra­tions with var­i­ous biotech out­fits — not to men­tion the con­tin­ued im­pact Lon­za will have on the pro­duc­tion of Covid-19 vac­cines.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

JP Gabriel, Ocugen

JP Gabriel watched from the bleach­ers as the pan­dem­ic raged. Now head of sup­ply chain at Ocu­gen, he's ready to bat

The world was in the middle of the most pressing public health risk his generation had ever seen, and JP Gabriel felt like he was sitting on the sidelines. As a VP of biologics and mRNA manufacturing at Ultragenyx, Gabriel watched from the sidelines as players like Pfizer/BioNTech and Moderna used mRNA tech to chase their own Covid-19 vaccines.

This month, Gabriel got the chance to get his hands dirty against the pandemic — but it won’t be with mRNA.

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Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

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Bayer first set roots in Berkeley back in 1974, when it was still operating as Miles Labs. The site has pumped out three hemophilia A treatments for distribution worldwide; but now, as the pharma continues its cell and gene therapy push, it has something bigger in mind.

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Evotec strength­ens its French con­nec­tion, pledg­ing to drop $120M in­to Toulouse plant for Covid-19 an­ti­bod­ies

Much of the recent focus on manufacturing capacity for Covid-19 has been on vaccines, and for good reason, too. But countries are also hoping to build a big enough footprint to produce pandemic-level monoclonal antibodies, and now France is working with Germany’s Evotec to stay prepared.

Evotec will lay out $120 million with a $60 million boost from multiple French governments and investors to build a new biologics facility in Toulouse that will expand its capacity to produce therapeutic antibodies for Covid-19, the German CDMO and biotech said this week.

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Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

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