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human health

GreenLight Biosciences and Samsung Biologics complete first commercial-scale engineering run for mRNA Covid-19 vaccine

●  GreenLight’s messenger RNA production process is transferable to large-scale equipment and CMO facilities​

●  Technology transfer and scale-up from lab bench to Samsung’s commercial facility was completed in seven months

●  GreenLight’s mRNA synthesis reaction had a titer of 12g/L at a commercial scale and produced 650g of mRNA

●  The mRNA synthesis reaction was achieved without the need for customization, using standard equipment for Contract Development and Manufacturing Companies (CDMO)

●  Commercial-scale run has demonstrated production—in a single facility—of both Drug Substance and LNP formulation, allowing the production of bulk Drug Product

Boston and Incheon, S. Korea, August 1, 2022—GreenLight Biosciences (Nasdaq: GRNA), a biotechnology company dedicated to making ribonucleic acid (RNA) products affordable and accessible for human health and agriculture, and Samsung Biologics (KRX: 207940.KS), a leading global CDMO providing fully integrated end-to-end contract development and manufacturing services, announced the successful completion of the first commercial-scale engineering run for the companies’ mRNA production partnership.

Since the announcement of the strategic partnership between GreenLight Biosciences and Samsung Biologics in late 2021, technology transfer and scale-up from the lab bench to Samsung’s commercial facility was completed in seven months, demonstrating platform adaptability and scalability.

GreenLight’s process—from drug substance and lipid nanoparticle formulation to bulk drug product—can be completed in the same facility, an important capability. GreenLight’s mRNA synthesis reaction had a titer of 12g/L at commercial scale and produced 650g of mRNA.

The company’s RNA platform allowed GreenLight to move from conceptualizing an mRNA vaccine to delivering released clinical trial material in less than two years. With the demonstration at Samsung, and with GreenLight’s Covid booster vaccine clinical trial expected to start in 2022, GreenLight would be capable of supplying mRNA vaccine at a commercial scale.

“This demonstrates a major achievement in our continuing goal to offer one-stop end-to-end mRNA production from Drug Substance to Aseptic Fill Finish to commercial release, all from a single site, as we strive across our biomanufacturing network to fight the pandemic,” said John Rim, CEO and President at Samsung Biologics.

Earlier this year, Samsung Biologics completed the expansion of its mRNA drug substance manufacturing suite at its Songdo headquarters, where the company is now fully equipped to provide end-to-end mRNA production for clients.

“One of the greatest challenges when producing quality pharmaceuticals is advancing from a small lab to large-scale commercial production,” said GreenLight CEO Andrey Zarur. “We are grateful for the help and support of Samsung in demonstrating that our small mRNA process can scale in a linear fashion to the industrial scale that will be needed to help satisfy the vaccine needs of humanity.”

To date, all comparability data conforms with expected outcomes, indicating successful scale up and fit of GreenLight’s process to Samsung Biologics’ Songdo facility. A second engineering run will start in August, to implement improvements indicated by the first run and to demonstrate repeatability at scale​.

About GreenLight Biosciences

GreenLight Biosciences aims to address some of the world’s biggest problems by delivering on the full potential of RNA for human health and agriculture. Our RNA platform allows us to research, design, and manufacture for human, animal, and plant health. In human health, this includes messenger RNA vaccines and therapeutics. In agriculture, this includes RNA to protect honeybees and a range of crops. The company’s platform is protected by numerous patents. GreenLight’s human health product candidates are in the pre-clinical stage, and its product candidates for the agriculture market are in the early stages of development or regulatory review. GreenLight is a public benefit corporation that trades under the ticker GRNA on Nasdaq. For more information, visit https://www.greenlightbiosciences.com/

GreenLight Biosciences contact:

David Pesci

Head of Media Relations

[email protected]

For press, email: [email protected]

For investors, email: [email protected]

About Samsung Biologics Co., Ltd.

Samsung Biologics (KRX: 207940.KS) is a fully integrated CDMO offering state-of-the-art contract development and manufacturing services. With proven regulatory approvals, the largest capacity, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide. For more information, visit samsungbiologics.com.

Samsung Biologics contact:

Claire Kim

Senior Director of Global Marketing Communications

[email protected]

Notes to editors

  1. GreenLight and Samsung Biologics announced their partnership in December 2021:
    https://greenlightbiosciences.com/greenlight-biosciences-and-samsung-biologics-announce-collaboration/
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Co-developer of COVID-19 Vaccine Joins GreenLight Advisory Board

Dr. Graham is an author on more than 500 scientific publications and a thought leader on emerging viral diseases and pandemic preparedness. He was involved in the advanced evaluation of vaccines and monoclonal antibodies for HIV, Ebola, and Chikungunya. He also developed novel vaccines for RSV, influenza, Zika, paramyxoviruses, and coronaviruses including the first COVID-19 vaccine and monoclonal antibody to enter clinical testing and that subsequently achieved Emergency Use Authorization and licensure.

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a scientist in a clean suit works on a GreenLight bench

Business Insider: COVID-19 vaccines sparks expansion of RNA research

Business Insider reports on GreenLight Bioscience’s plans to expand its RNA research work, including to include human therapeutics. An extract from the article is below:

For instance, GreenLight Biosciences expanded its mRNA work last year from focusing on pesticide alternatives to include human therapeutics. Now, GreenLight is riding the mRNA hype to a public debut, agreeing to a $1.2 billion special-purpose acquisition company deal in August.

“GreenLight aims to solve some of the world’s biggest problems with RNA, from affordable vaccines and therapies to protecting honeybees,” GreenLight CEO Andrey Zarur said in a statement, adding that clinical trials for its COVID-19 vaccine were scheduled to begin next year.

Read the full article here.

Find out more about how GreenLight manufactures RNA here.

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VP of marketing Catie Lee being interviewed in a Greenlight factory

News10NBC: GreenLight Biosciences opens new RNA facility in Rochester

Local TV station News10NBC reports on the opening of our new RNA production facility in Rochester. An extract is below.

Workers say this plant- has manufactured more RNA than anywhere else on earth and this is a big step for those in manufacturing for human, animal, and plant health.

“GreenLight Biosciences is at the start of something really exciting we’re using RNA to solve some of the world’s biggest problem,” GreenLight Biosciences marketing director Catie Lee said.

Watch the report here.

Find out more about how GreenLight manufactures RNA here.

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The National: Africa needs to be self-reliant in vaccine production

Andrey Zarur, CEO of GreenLight Biosciences, writes an opinion piece for The National about how vaccine production needs to progress for the world to recover from the pandemic.

Andrey Zarur, CEO of GreenLight Biosciences, writes an opinion piece for The National about how vaccine production needs to progress, particularly in Africa, for the world to recover from the pandemic. Some extracts from the piece are below.

The pandemic will not end until everyone is vaccinated – and quickly. At the current pace, full vaccination will not occur until the end of 2022, but we must find a way to make enough vaccines, about 15 billion doses, before serious vaccine-resistant variants overtake us. That’s daunting, but it is possible to meet the challenge.

Some countries may share their vaccines with others, but to produce vaccines continually and efficiently, we need production sites distributed around the world. GreenLight’s novel RNA manufacturing process – quick to start, built for scale, and using small bioreactors – may be part of the solution. We are partnering with governments, multilateral institutions and companies on all continents to accelerate pandemic response.

Vaccines for Covid-19 cannot yet be manufactured in Africa. Local manufacturing – that is to say, a factory on the continent itself – would help meet the demand and increase the pace of vaccinations. The Covax initiative plans to send 600 million doses to Africa, enough for only about 20 per cent of its population; so far only 20 million have been delivered. Africa is, essentially, at the back of the line.

The last year has been a showcase for the power of science and of human ingenuity. To go from identifying a pandemic virus to getting a vaccine for that virus into millions of arms within a year is extraordinary, when the normal process takes a decade or more. But to fight this deadly virus and all its variants requires the agility and ingenuity to equip every country with the tools it needs to stay victorious.

Read the full article here.

Find out more about how GreenLight manufactures RNA here.


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