Jung Jin Seo, Celltrion founder (Celltrion)

Ko­re­a's Cell­tri­on in­vests $453M in­to new man­u­fac­tur­ing plant, re­search cen­ter

Less than a year af­ter blue­print­ing a $514 mil­lion bi­o­log­ics plant in Chi­na, Cell­tri­on is pour­ing an­oth­er $453 mil­lion in­to build­ing a new re­search cen­ter and man­u­fac­tur­ing fa­cil­i­ty in its home city of In­cheon, Ko­rea.

Like Sam­sung Bi­o­log­ics, which is plan­ning to con­struct a $2 bil­lion “su­per plant,” Cell­tri­on said it’s look­ing to “proac­tive­ly re­spond to the rapid­ly in­creas­ing glob­al bio­phar­ma­ceu­ti­cal de­mand, and fo­cus our ca­pa­bil­i­ties on more flex­i­ble and ef­fi­cient bio­phar­ma­ceu­ti­cal re­search in the fu­ture.”

Ear­li­er this year Cell­tri­on founder Jung Jin Seo — the sec­ond-rich­est per­son in South Ko­rea — had chart­ed an am­bi­tious vi­sion for his com­pa­ny over the next decade. The goal is to launch one biosim­i­lar prod­uct every year, reach­ing a to­tal num­ber of 18 prod­ucts by 2030, and al­so ex­pand in­to what he calls “bioin­no­v­a­tives.”

The biosim­i­lar mak­er will in­stall eight 7,500-liter in­cu­ba­tors at the new fac­to­ry. Next to it will be a re­search cen­ter com­pris­ing R&D, process de­vel­op­ment and clin­i­cal prac­tice, which is set to com­plete in Ju­ly 2022. All told, the site will em­ploy 3,000 new staffers.

“Many of our in­cu­ba­tors will short­en the batch in­ter­val,” the com­pa­ny said, ac­cord­ing to Ko­rea Bio­med­ical Re­view. “This will lead to an ac­tu­al pro­duc­tion vol­ume and sales con­tri­bu­tion com­pa­ra­ble to high­er than our ex­ist­ing pro­duc­tion fa­cil­i­ties.”

The fa­cil­i­ty is slat­ed to come on­line in June 2024. Com­bined with the ca­pac­i­ty from two ex­ist­ing plants, it will be able to pro­duce 250,000 liters of bi­o­log­ics an­nu­al­ly.

Per­haps best known in the US for its strug­gles in push­ing copy­cat ver­sions of Rit­ux­an and Her­ceptin, Cell­tri­on has al­so dab­bled in­to new drug de­vel­op­ment, most re­cent­ly test­ing an an­ti­body treat­ment for Covid-19.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,800+ biopharma pros reading Endpoints daily — and it's free.

Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

Leen Kawas, Athira CEO

Biotech founder placed on leave as $400M Alzheimer's start­up idea comes un­der scruti­ny

Athira Pharma, the Alzheimer’s biotech that emerged out of obscurity last year and raised nearly $400 million for a dark-horse approach to treating neurodegeneration, has found itself in sudden turmoil.

On Tuesday evening, the company released a terse statement announcing that CEO and founder Leen Kawas had been placed on administrative leave while an independent review board investigated “actions stemming” from her doctoral research at Washington State University. Mark Litton, who joined the company as COO two years ago, will take over day-to-day operations, they said.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,800+ biopharma pros reading Endpoints daily — and it's free.

Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

Now, with a massive check in hand, the drugmaker is willing to put its intuition to the test.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,800+ biopharma pros reading Endpoints daily — and it's free.

Tom Hochuli, Vibalogics CEO

Vi­ral man­u­fac­tur­er Viba­log­ics plots out ex­pan­sion at Ger­man site as US growth plans are un­der­way

A German CDMO specializing in viral manufacturing is expanding its operations in Europe by building out an existing plant — and soon, it will be its own landlord, too.

Vibalogics has begun the first stage of a $50 million expansion of its Cuxhaven, Germany facility, the company announced. It will also buy the site outright from the current owner.

The CDMO specializes in the production of oncolytic viruses and viral vector-based vaccines and gene therapy products. The expansion will add another 100,000 square feet at the site for quality batch release and stability studies, drug product fill-finish and process development.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,800+ biopharma pros reading Endpoints daily — and it's free.

FDA's con­tro­ver­sial Aduhelm de­ci­sion leaves ALS pa­tients feel­ing spurned

The FDA’s controversial approval of Biogen’s Aduhelm drug for Alzheimer’s disease has been met with fierce resistance from all corners of the biopharma industry, but few seem to be as upset with the decision as ALS patients and advocacy groups.

For all that’s already been written and discussed about the agency’s announcement, from the drug’s exorbitantly high price of $56,000 per year to criticism over lowered standards, ALS patients see something more. ALS patients and associations say they largely regarded Aduhelm’s approval as a bittersweet double standard: happy that those with Alzheimer’s have a new drug available, but questioning how the FDA evaluated Biogen’s drug compared to the experimental programs being studied for their own disease.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,800+ biopharma pros reading Endpoints daily — and it's free.

Spring reg­u­la­to­ry agen­da: What’s com­ing soon-ish from the FDA

The FDA’s lack of a permanent commissioner does not seem to be halting its progress to propose and finalize dozens of new regulations, with the latest batch covering everything from adverse event reporting to supplemental application submissions to annual reports for INDs.

Overall, FDA expects to release more than 40 new proposed regulations and finalize another 24 in the coming months and years.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.