Samsung Biologics takes on manufacturing duties for GreenLight’s Covid-19 vaccine

Sam­sung Bi­o­log­ics has en­tered an agree­ment with South Ko­re­an biotech Green­Light Bio­Sciences to man­u­fac­ture its mR­NA Covid-19 vac­cine at com­mer­cial scale, the two com­pa­nies an­nounced.

Sam­sung Bi­o­log­ics, one of the fastest grow­ing man­u­fac­tur­ers in the world right now, will use its vac­cine man­u­fac­tur­ing ex­per­tise to help pa­tients in low­er-in­come coun­tries, CEO John Rim said in a press re­lease. This will help ex­pand their ca­pa­bil­i­ties from drug sub­stance to asep­tic fill-fin­ish and all the way to com­mer­cial re­lease from one site.

‘At this time of ur­gent glob­al de­mand, we will strive for seam­less ser­vice across our bio­man­u­fac­tur­ing net­work to fight the COVID pan­dem­ic and in turn, help make progress to­wards Ko­rea’s vac­cine hub goal,’ he said in a press re­lease.

Sam­sung’s Song­do fa­cil­i­ty will be ready for cGMP op­er­a­tions in ear­ly 2022, the com­pa­ny said. It added drug sub­stance ca­pa­bil­i­ties to the site ear­li­er this year, in an at­tempt to be proac­tive in ac­com­mo­dat­ing clients’ needs.

In Au­gust, Green­light re­verse-merged its way on­to the Nas­daq, land­ing a $1.5 bil­lion val­u­a­tion af­ter merg­ing with the SPAC En­vi­ron­men­tal Im­pact Ac­qui­si­tion Corp., which is backed by Canac­cord Ge­nu­ity Group and Hud­son Bay Cap­i­tal Man­age­ment. That merg­er land­ed the com­pa­ny $207 mil­lion and $105 mil­lion in PIPE fi­nanc­ing.

The com­pa­ny was found­ed in 2008 to use its mR­NA tech­nol­o­gy to pro­tect both hu­mans and agri­cul­ture, in­clud­ing hon­ey­bees and crops. It was vir­tu­al­ly un­known be­fore the merg­er. Now, the com­pa­ny is look­ing to set up a blue­print for vac­ci­nat­ing the world from Covid-19, and hopes to do so through im­proved mR­NA man­u­fac­tur­ing ca­pa­bil­i­ties. It’s been work­ing on sea­son­al flu and sick­le cell dis­ease vac­cines as well, but it got its start while try­ing to shake up the pes­ti­cides mar­ket for in­dus­tri­al agri­cul­ture.

‘There is an ur­gent need to de­vel­op vac­cines for the whole world,’ Green­Light CEO An­drey Zarur said in a press re­lease. ‘Our vac­cine tri­al will open the way to make vac­cines that are avail­able to every­body, not just cit­i­zens of de­vel­oped coun­tries.’

There are cur­rent­ly three plants at the Sam­sung Song­do cam­pus. A fourth is on the way, and the CD­MO just got ap­proved to build a fifth in No­vem­ber.

Sam­sung will fin­ish the $259 mil­lion site on 32,808-square-feet of land in the city, which comes on the heels of its newest cell line, which launched in Au­gust 2020. It’s al­so in talks to ac­quire more land to de­vel­op a sec­ond bio com­plex. This, and all of Sam­sung’s oth­er ex­pan­sions, come on the heels of a 64% in­crease in sales from last year to $375 mil­lion, large­ly thanks to an in­creased de­mand for CD­MO ser­vices.

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Merck’s new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO  — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

‘I think it is super worrisome,’ Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, ‘This is not going to be good.’

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Fujifilm Diosynth Biotechnologies is in the middle of a monumental point in the company’s 10-year history, and the CDMO is about to grow even more, as it sets out to be the ‘beating heart’ of the UK’s North East Life Sciences ecosystem.

A site in Billingham, Teeside, UK will receive a $453.72 million investment package from the manufacturer to double the existing footprint and create the largest multi-modal biopharmaceutical manufacturing site in the UK, bringing another 350 jobs to the region by late 2023.

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GenScript, Suzhou Abogen, and Walvax Biotechnology have announced the three companies will be collaborating on a Covid-19 mRNA vaccine project dubbed ABO-O28M.

WalVax will submit a BLA for the project, and GenScript will provide exclusive manufacturing services, according to Asia One.

The project stems form an agreement between Abogen, the  Academy of Military Medical Sciences (AMMS) of the PLA Academy of Military Science and Walvax, which gained clinical trial approval in June 2020. It was one of the first vaccine projects approved by China’s government, and GenScript used its plasmid GMP manufacturing to accelerate into clinical trials.

The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ‘069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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Vas Narasimhan, Novartis CEO (Thibault Camus/Pool via AP Images)

Thursday marks Novartis’ annual R&D day, and with it comes CEO Vas Narasimhan’s attempt to spotlight the company’s pipeline strategy and emerging stars.

The biggest question entering Thursday’s presentation dealt with how the big biopharma will make up revenues from upcoming generic competition — Novartis says within the next five years, generics will eat away roughly $9 billion in sales. To offset this, Narasimhan outlined a strategy for 4% growth or higher until 2026, focusing on six key medicines he believes will see multibillion dollar profits during this time.

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

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Lisa Deschamps, AviadoBio CEO

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

‘So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,” he told Endpoints News. 

Amgen’s blockbuster Otezla just racked up another Phase III win as it looks to continue expanding on its multibillion-dollar revenue stream.

The drug hit the primary endpoint in a trial researching its use in moderate to severe genital psoriasis, Amgen announced in the topline readout Wednesday afternoon. On top of that, all secondary endpoints were hit, demonstrating ‘meaningful and significant improvements,’ the company said.
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