John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Up­dat­ed: Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CD­MO arm of one of South Ko­rea’s largest con­glom­er­ates has post­ed its year-end re­sults and plans for 2023, which in­clude new con­struc­tion.

Sam­sung Bi­o­log­ics net­ted north of KRW 3 tril­lion ($2.4 bil­lion) in 2022 rev­enue and an op­er­at­ing prof­it of KRW 983.6 bil­lion ($799 mil­lion), which the com­pa­ny tout­ed on Fri­day as “record-high earn­ings.” The rev­enue boost was 55% com­pared to 2021.

“Our steady fi­nan­cial per­for­mance in the fourth quar­ter was dri­ven by sol­id busi­ness growth with strong op­er­a­tional ex­cel­lence and full uti­liza­tion across all plants, fur­ther ac­cel­er­at­ed by the full in­clu­sion of Sam­sung Bioepis in 2022,” said Sam­sung Bi­o­log­ics CEO John Rim in a re­lease. The com­pa­ny closed on its ac­qui­si­tion of Sam­sung Bioepis in April.

Rim has some ma­jor ex­pan­sion goals for 2023, in­clud­ing a new an­ti­body-drug con­ju­gate man­u­fac­tur­ing suite at its “su­per plant” cur­rent­ly un­der con­struc­tion in In­cheon, South Ko­rea. That plant is ex­pect­ed to open lat­er this year.

In an emailed state­ment to End­points News, Rim said that Plant 4 is ex­pect­ed to start full op­er­a­tions in the mid­dle of 2023, giv­ing Sam­sung Bi­o­log­ics a to­tal of 604,000 L in ca­pac­i­ty.

“The in­crease in sales can be at­trib­uted to new con­tracts made with glob­al phar­ma com­pa­nies, fa­vor­able mar­ket cur­ren­cy, full ac­qui­si­tion of Sam­sung Bioepis, and com­plete uti­liza­tion of all plants in 2022,” Rim said in the state­ment to End­points.

Mean­while, Sam­sung Bi­o­log­ics al­so spelled out plans to kick off con­struc­tion at its Bio Cam­pus II. The land for the sec­ond cam­pus was pur­chased last year for KRW 426 bil­lion ($346 mil­lion), lo­cat­ed with­in the Song­do In­dus­tri­al Clus­ter in South Ko­rea. It will be 30% larg­er than the com­pa­ny’s cur­rent one and will boast a new plant and in­no­va­tion fa­cil­i­ty, ac­cord­ing to the com­pa­ny.

Sam­sung Bi­o­log­ics al­so hopes to in­crease its foot­print in the US by open­ing sales of­fices, pri­mar­i­ly in New Jer­sey and Boston, but the specifics were not dis­closed.

“We ex­pect the con­tin­ued busi­ness mo­men­tum dri­ven by our ex­pan­sions in ca­pac­i­ty, port­fo­lio, and ge­og­ra­phy. We will al­so con­tin­ue to study new ar­eas of busi­ness op­por­tu­ni­ties in a con­sis­tent­ly evolv­ing bio­phar­ma­ceu­ti­cal mar­ket,” Rim’s state­ment said.

Sam­sung gave its biotech and bi­o­log­ics man­u­fac­tur­ing arms a fair bit of at­ten­tion last year as the wider con­glom­er­ate raised its spend­ing to in­vest in new lines of busi­ness, in­clud­ing biotech. Speak­ing to End­points at BIO in San Diego last year, Rim said that a sig­nif­i­cant por­tion of that mon­ey will be in­vest­ed in­to biotech, but he did not give a hard fig­ure. Rim did note at the time that biotech­nol­o­gy would be the sec­ond arm of growth be­hind elec­tron­ics.

How­ev­er, Sam­sung Bi­o­log­ics has al­so seen a healthy amount of com­pe­ti­tion from oth­er Asia-based CD­MOs look­ing to grow. The CD­MO branch­es for South Ko­re­an con­glom­er­ates Lotte and SK made pur­chas­es or ex­pan­sions last year along with Japan­ese pow­er­house Fu­ji­film, which spent mil­lions to kick off projects in the US and Eu­rope.

This sto­ry has been up­dat­ed with an emailed state­ment from Sam­sung Bi­o­log­ics CEO John Rim. 

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.

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.

Man­u­fac­tur­ing roundup: Catal­ent to pro­duce low-cost ver­sion of nalox­one; CSL opens R&D site

Catalent will be manufacturing a low-cost version of the opioid overdose treatment naloxone as part of a contract with Harm Reduction Therapeutics.

Catalent plans to manufacture the treatment at its facility in Morrisville, NC. No financial details on the deal were disclosed.

Harm Reduction was granted priority review status for the NDA on its spray last year. The company has been working on a naloxone product since 2017. It is anticipating approval in July of this year and a US launch in early 2024.

As­pen looks to re­bound in pro­duc­tion and rev­enue af­ter Covid-19

Last year, South African-based vaccine manufacturer Aspen Pharmacare was facing reports that it had not received a single order for its manufactured Covid-19 shots and that manufacturing lines were sitting idle. But now the vaccine producer is looking to turn things around.

Aspen’s disclosure of its financial results in March unveiled that manufacturing revenue had decreased by 12% to R 603 million ($33.8 million), which Lorraine Hill, Aspen Group’s COO, said is attributable to lower Covid vaccine sales.

Ribbon cutting ceremony for Thermo Fisher's new cell therapy manufacturing site in San Francisco

Ther­mo Fish­er moves on cam­pus with new cell man­u­fac­tur­ing site in San Fran­cis­co

Thermo Fisher Scientific is putting down more roots in the Bay Area.

The manufacturer opened the doors to a new cell therapy manufacturing facility next to the University of California-San Francisco Medical Center’s Mission Bay campus and on the university’s campus.

UCSF and Thermo Fisher have had a partnership since 2021, with the new site focusing on manufacturing cell therapeutics for certain cancers, including glioblastoma and multiple myeloma. The new site plans to use Thermo Fisher’s expertise in manufacturing services to help UCSF accelerate the development of cell therapies and eventually get them into the clinic, said Dan Herring, the general manager of cell therapy services at Thermo Fisher, in an interview with Endpoints News.

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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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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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.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”