Posts tagged:

vaccine production

Nature: mRNA printers kick-start personalized medicines for all

GreenLight Biosciences has been profiled in Nature Biotechnology magazine as a pioneer of mRNA printers, which can produce low-cost vaccines and made-to-order treatments for a range of different diseases.

Greenlight Biosciences uses cell-free microbial lysates to manufacture mRNA. The company has adapted its inexpensive small interfering RNA production technology for insect and fungal pathogen control in agriculture and apiculture to human health applications. “We use microbial strains to produce the building blocks of RNA,” says cofounder and CEO Andrey Zarur.

Read the full article here.

Find out more about how GreenLight manufactures RNA.

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EndPoints: GreenLight Biosciences celebrates manufacturing milestone

GreenLight Biosciences first commercial-scale engineering run of its Covid-19 vaccine booster candidate with Samsung was reported in EndPoints News as a manufacturing milestone. In an interview with the publication, GreenLight CEO Andrey Zarur said:

“The beauty of our platform is that once we have that we have ensured that whatever the leading candidate is that we liked at that microscopic scale is fully scalable to produce hundreds of millions of doses very rapidly,” he aid. “So, the value of the manufacturing platform itself gets amplified, if you will, by the fact that we have this upstream discovery engine.”

Read the full article here.

Find out more about how GreenLight manufactures RNA.

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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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Bloomberg: Honeybees Find Lifeline in Covid Tech

GreenLight Biosciences features in Bloomberg for its use of Covid RNA technology to target parasites partly blamed for the honeybee crisis. Extracts from the article are below:

Technology used to develop Covid-19 vaccines may also help combat a honeybee-killing pest.

GreenLight Biosciences is developing an RNA-based syrup to attack varroa mites, a parasite that attaches itself to honeybees and feeds off them while spreading diseases. The RNA acts as an “off switch” that interferes with the mites, disrupting their ability to lay offspring that attach to bees, said Mark Singleton, chief commercial officer and general manager of plant health at the Boston-based firm.

Read the full article here.

Find out more about how GreenLight manufactures RNA.

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Scientific American: Lessons for a Plant Pandemic

GreenLight Biosciences is referred to in Scientific American in its piece asking “What Did COVID Teach Us about Preparing for a Plant Pandemic?”.

GreenLight Biosciences is a part of the effort to address the plant pandemic by tackling diseases and mutations faster than is possible with conventional pesticides or processes. An extract from the article is below:

Establish libraries for rapid screening and optimization: Genetic libraries have been fundamental to synthetic biology innovation because they permit the rapid construction and evaluation of diverse populations of genetic variants. The same framework applies to biofungicides; we can screen thousands to millions of variants to identify and optimize those that selectively interfere with a given pathogen. Once we know that a specific agent can disrupt a disease, we can develop the means to deliver the solution, whether it’s through an engineered microbe (as we are doing at Joyn Bio) or biomolecules like RNA (pursued by GreenLight Biosciences) and proteins (such as Biotalys’ antibody technology).

Read the full article here.

Find out more about how GreenLight manufactures RNA.

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YonHap: GreenLight in mRNA deal with Samsung Biologics

Greenlight Biosciences’ deal with Samsung Biologics to establish a one-stop production capability for manufacturing messenger RNA (mRNA) vaccines was reported by Yonhap News Agency.

Samsung has completed the addition of the new mRNA vaccine substance production capability at its plant in Songdo, Incheon, 40 kilometers west of Seoul, and began producing drug substances for COVID-19 vaccines of GreenLight Biosciences Inc. of the United States late last month.

Samsung Biologics, a leading contract development and manufacturing organization (CDMO), signed a drug substance supply agreement with the American biotech company last year

Read the full article here.

You can read more about our deal with Samsung Biologics in this article by BioProcess.

Find out more about how GreenLight manufactures RNA.

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EndPoints: Q&A with GreenLight CEO Andrey Zarur

GreenLight Biosciences CEO, Andrey Zarur, is interviewed by Endpoints News.

He outlines how he is determined not to repeat the mistakes from the last pandemic and speaks about GreenLight’s latest deal with the Serum Institute.

Can you talk to me about how you’ve identified the shingles vaccine as a key area of focus?

[Shingles] can be dangerous and is extraordinary painful. [A shingles vaccine] is a huge unmet need, there are billions of people who are at risk of shingles who don’t have a solution, and of course there is no established business model. So we’re focused on a major need that’s likely to affect everybody over the age of 60.

Read the full article here.

Find out more about how GreenLight manufactures RNA.

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BioCentury: GreenLight messenger RNA shingles vaccine deal with Serum Institute of India

Agreement to manufacture and commercialize a messenger RNA shingles vaccine and two other RNA products.

There is a high need for shingles vaccines in low- and middle- income countries where most people have not been vaccinated against chickenpox. Shingles is caused by reactivation of varicella zoster virus (VZV), which causes chickenpox; vaccination against chickenpox greatly reduces the risk of shingles.

Read the full article here.

Find out more about how GreenLight manufactures RNA.

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Endpoints: GreenLight licenses mRNA shingles vaccine

“GreenLight’s approach resonates with our mission to make healthcare equitable for all,” SII CEO Adar Poonawalla said in a statement. “Messenger RNA technology will play a key role in reducing the burden of human suffering caused by vaccine-preventable diseases across LMICs.”

There is an option to expand the license to two additional vaccines or therapies to be named later, GreenLight said in a release, and the shingles vaccine manufacturing process will be transferred to the SII facility in Pune, India.

Read the full article here.

Find out more about how GreenLight manufactures RNA.

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