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messenger RNA

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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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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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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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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Hands of a GreenLight employee pipette liquid into tubes at a GreenLight Medford facility

GreenLight and ENVI announce a recent financing to support their pending business combination

Boston, January 5, 2022—Greenlight Biosciences Inc. (“GreenLight”) and Environmental Impact Acquisition Corp. (Nasdaq: ENVI) (“ENVI”) announced today that GreenLight recently completed a financing transaction in which certain investors effectively pre-paid $35.25 million of the purchase price of the previously announced $125.5 million private placement offering expected to close concurrently with the planned business combination between GreenLight and ENVI (such private placement, the “PIPE”).

In connection with such pre-payment, GreenLight issued $35.25 million of convertible securities to certain of the investors that have committed to purchase shares of ENVI common stock in the PIPE. Upon the closing of the anticipated business combination, the convertible securities will be canceled and the amounts paid thereunder by such investors will constitute payment for a corresponding portion of such participating investor’s PIPE purchase price.

The proceeds from the issuance of the convertible notes will be used to fund ongoing operations at GreenLight, including advancements in critical research and development programs.

S2G Ventures, Fall Line Capital, Rivas Capital, The Jeremy and Hannelore Grantham Environmental Trust, Viceroy, Morningside Venture Investments, and Spruce Capital participated in this PIPE prepayment transaction.

About GreenLight 

Founded in 2008, GreenLight aims to solve some of the world’s biggest problems by delivering on the full potential of RNA for human health and agriculture. 

In human health, this includes mRNA vaccines and therapeutics. In agriculture, this includes RNA to protect honeybees and a range of crops. The company’s breakthrough cell-free RNA manufacturing platform, which is protected by numerous patents, allows for cost-effective and scalable production of RNA. For more information, visit https://www.greenlightbiosciences.com/. 

About Environmental Impact Acquisition Corp.

Environmental Impact Acquisition Corp. is a Special Purpose Acquisition Company. The Company is sponsored by CG Investments Inc. VI, an affiliate of Canaccord Genuity, which manages several investment vehicles.

Forward-Looking Statements 

This press release contains forward-looking statements within the meaning of the federal securities laws with respect to the business of GreenLight Biosciences, Inc. and its proposed transaction with Environmental Impact Acquisition Corp. (“ENVI”), including statements regarding the anticipated benefits and uses of GreenLight’s product candidates, the market opportunities for GreenLight’s product candidates, timing of clinical trials, and the timing of commercial launch of product candidates, and the anticipated business combination with ENVI. These forward-looking statements are generally identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from these forward-looking statements, including but not limited to: the need to obtain regulatory approval for GreenLight’s product candidates; the risk that clinical trials will not demonstrate that GreenLight’s therapeutic product candidates are safe and effective; the risk that GreenLight’s product candidates will have adverse side effects or other unintended consequences, which could impair their marketability; the risk that GreenLight’s product candidates do not satisfy other legal and regulatory requirements for marketability in one or more jurisdictions; the risks of enhanced regulatory scrutiny of mRNA solutions; the risk of significant delays in research, development, testing, clinical trials and regulatory approval; the potential inability to achieve GreenLight’s goals regarding scalability and affordability of its product candidates; the anticipated need for additional capital to achieve GreenLight’s business goals; changes in the industries in which GreenLight operates; changes in laws and regulations affecting the business of GreenLight; the risk that the proposed business combination with ENVI may not be completed in a timely manner or at all, which may adversely affect the price of ENVI’s securities; the failure to satisfy conditions to the consummation of the transaction; the occurrence of any event, change or other circumstance that could give rise to the termination of the business combination agreement; risks that the proposed transaction disrupts current plans and operations of GreenLight; and the potential inability to implement or achieve business plans, forecasts, and other expectations after the completion of the proposed transaction. The foregoing list of factors is not exhaustive. Readers should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of the registration statement on Form S-4 discussed below and other documents filed by ENVI from time to time with the U.S. Securities and Exchange Commission (the “SEC”). These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and ENVI and GreenLight assume no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise. Neither ENVI nor GreenLight gives any assurance that GreenLight or ENVI, or the combined company, will achieve any result described in any forward-looking statement.

Important Information and Where to Find It 

This press release may be deemed to relate to a proposed transaction between GreenLight Biosciences, Inc. and Environmental Impact Acquisition Corp. This press release does not constitute either (a) a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed business combination or (b) an offer to sell or exchange, or the solicitation of an offer to buy or exchange, any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, sale or exchange would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. 

ENVI has filed an amended registration statement on Form S-4with the SEC, which includes a document that serves as a preliminary prospectus and proxy statement of ENVI, referred to as a proxy statement/prospectus. The final proxy statement/prospectus will be sent to all ENVI stockholders after the registration statement is declared effective by the SEC. ENVI has also filed and will file other documents regarding the proposed transaction with the SEC. This press release does not contain all of the information that will be contained in the final proxy statement/prospectus or other documents filed with the SEC. Before making any voting decision, investors and security holders of ENVI are urged to read the registration statement, the final proxy statement/ prospectus and all other relevant documents filed or that will be filed with the SEC in connection with the proposed transaction as they become available because they will contain important information about the proposed transaction.

Investors and security holders will be able to obtain free copies of the registration statement, the final proxy statement/prospectus and all other relevant documents filed or that will be filed with the SEC by ENVI through the website maintained by the SEC at www.sec.gov or by sending a written request to ENVI at: [email protected].

No Offer or Solicitation

This press release shall not constitute a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed business combination. This press release shall also not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any states or jurisdictions in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act of 1933, as amended.

Participants in the Solicitation 

ENVI, GreenLight and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from ENVI’s shareholders in connection with the proposed transaction. A list of the names of such directors and executive officers and information regarding their interests in the proposed business combination will be contained in the final proxy statement/prospectus when available. You may obtain free copies of these documents as described in the preceding paragraph. 

Contact: 

Thomas Crampton 

SVP & Head of Corporate Affairs 

GreenLight Biosciences 

[email protected] 

+1 914 202 2762 

+44 7826 995794 


Unherd: Should Big Pharma be destroyed?

GreenLight Biosciences is featured in Unherd magazine on the need for smaller, more innovative companies to help roll out Covid vaccines to the rest of the world.

Credit: Unherd/Erik McGregor/LightRocket via Getty

Andrey Zarur, the CEO of the biotech firm GreenLight, who are producing their own mRNA vaccine for Covid at the moment, comes at the whole thing from a different angle“Pfizer was not designed to make low-cost therapeutics available to every corner of the world,” he says: it’s a 150-year-old company with settled investors and a particular way of working.

He compares it to Apple. “You have a $1,000 iPhone 13,” he says. “Who’s that designed for? My children. Idiot teenagers with rich parents.” Poorer countries need smartphones too, but the solution is not to force Apple to sell smartphones to Ethiopia at a discount. “What you need is an innovative company with different processes.” Instead of demanding changes from 150-year-old companies that are very good at the specific things they do, create smaller, newer companies which do the thing you want. “There’s six billion people in the developing world,” says Zarur. “You should be able to figure out a way to turn a reasonable profit with reasonably priced drugs.”

Read the full article here.

Find out more about how GreenLight manufactures RNA.

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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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