John Rim, Samsung Biologics CEO

Sam­sung Bi­o­log­ics to kick off $1.5B+ plant con­struc­tion in South Ko­rea

The CD­MO gi­ant Sam­sung Bi­o­log­ics will be start­ing the con­struc­tion of its man­u­fac­tur­ing plant at the Song­do site in South Ko­rea.

Sam­sung an­nounced to­day that it will in­vest over $1.5 bil­lion in the new fa­cil­i­ty. The CD­MO plans to break ground on the plant some­time in the first half of 2023, with it ful­ly op­er­a­tional by 2025.

The new plant, dubbed Plant 5, will al­so be the first piece to Sam­sung Bi­o­log­ic’s new Bio Cam­pus, known as Bio Cam­pus II. The fa­cil­i­ty will be 96,000 square me­ters or around 1,033,335 square feet and will be able to have a ca­pac­i­ty of 180,000 liters of prod­uct. Once Plant 5 is com­plete, this will bring the CD­MO’s man­u­fac­tur­ing ca­pac­i­ty to a to­tal of 784,000 liters of prod­uct.

John Rim, the pres­i­dent and CEO of Sam­sung Bi­o­log­ics said in a re­lease:

Giv­en the con­tin­u­ing in­crease in the de­mand for out­sourced man­u­fac­tur­ing of bio­phar­ma­ceu­ti­cals, we are proac­tive­ly mak­ing this in­vest­ment in align­ment with our growth strat­e­gy to fur­ther strength­en our stand­ing as a lead­ing CD­MO. The new fa­cil­i­ty will en­able us to pro­vide our cus­tomers with even greater in­no­va­tion and ser­vices that will in­crease speed to mar­ket and flex­i­bil­i­ty.

Sam­sung’s new cam­pus is ad­ja­cent to its cur­rent fa­cil­i­ties and plants in the Song­do In­dus­tri­al clus­ter, with the com­pa­ny pur­chas­ing 360,000 square me­ters last sum­mer. It will al­so be in­vest­ing about $5.7 bil­lion in­to the new cam­pus as well.

The com­pa­ny’s fourth plant start­ed op­er­a­tions in Oc­to­ber of last year — with a plan to start full op­er­a­tions by the mid­dle of this year.

In Sam­sung Bi­o­log­ics’ year­ly re­sults, it an­nounced it will be build­ing out a stronger pres­ence in the US by open­ing sev­er­al of­fices on both coasts. One of those of­fices will open next week in New Jer­sey.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

See­los Ther­a­peu­tics 'tem­porar­i­ly' stops study in rare neu­ro dis­or­der for busi­ness rea­sons

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

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.

Phar­maron ex­pand­ing Liv­er­pool man­u­fac­tur­ing fa­cil­i­ty with a $186M+ price tag

Liverpool may be known for rock and roll and premier league football, but the China-based contract manufacturer Pharmaron is looking to make it a bigger hub for cell and gene therapy manufacturing.

As part of Pharmaron’s further commitment to Merseyside county, it plans to build an 8,000-square-meter facility, or around 86,000 square feet, which includes a boost to the manufacturing capacity of 3,500 square meters, or 37,600 square feet. The price tag for the expansion will be £151 million ($186 million), with Pharmaron receiving a grant from the UK Government’s Life Sciences Innovation Manufacturing Fund (LSIMF).

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.”