Posts tagged:

messenger RNA

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 

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 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. 


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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two people attend to a vat in a large clean factory space

How to scale RNA production

The art and science of taking the RNA scale-up recipe from the lab to a manufacturing plant

“There’s a difference between baking a normal loaf of bread and a gigantic loaf 10,000 times bigger,” says Adam Shanebrook, a biotechnologist and pilot plant director at GreenLight Biosciences. “You’ll burn the outside and leave the inside uncooked.” His point: You can’t simply scale up chemical and biological processes. You have to be clever about it.

That is very much on the mind of researchers at GreenLight as they scale up their manufacturing from laboratory to commercial production for their RNA-based solutions targeted at Colorado potato beetles, a crop pest, and varroa mites, which decimate bee colonies. The company’s innovative cell-free RNA synthesis was shown to work at laboratory scale some years ago in Medford, Massachusetts, but GreenLight has opened a pilot plant at an old Kodak factory in Rochester, New York to make it work at a far greater scale.

Producing RNA in a lab or a factory typically involves gene-editing a cell, often a harmless bacterium. But the process doesn’t just manufacture RNA, it also makes the rest of the bacterium. That means that it is wasting a lot of energy and raw materials in making unwanted byproducts. What’s more, those byproducts are mixed in with the RNA you actually want, so you have to either separate them—an expensive and difficult process—or deal with an impure final product, full of debris left over from the cells.

The cell-free process

The cell-free process works rather differently. It uses harmless strains of E. coli—long used in the pharmaceutical industry to make things like human insulin—to make the starting materials for the cell-free reaction. To prepare for that, short rings of DNA called “plasmids” are made to provide assembly instructions for the cell-free RNA production step. Additionally, E. coli are used to make the enzymes that catalyze the production and assembly of the RNA molecule.

Then those products are put into a large vat containing a “soup” of nucleosides, the building blocks of RNA and DNA, and the enzymes pluck the floating nucleosides out of the soup, energize them so that they snap together like magnets, and assemble them in a line according to the DNA plasmids’ instructions. This has the advantages that it is faster than bacterial-cell production—perhaps 10 times faster, requiring about three hours per batch as opposed to 30 or so; it is cheaper; and it brings forth a far purer product, approximately 50-65% pure.

A large vat containing a “soup” of nucleosides, the building blocks of RNA and DNA, at GreenLight's Rochester, New York, manufacturing plant.
A large vat containing a “soup” of nucleosides, the building blocks of RNA and DNA, at GreenLight’s Rochester, New York, manufacturing plant.

By 2017, that was all shown to work in the lab. But although it might be easy to make an 8-inch baguette in a home oven, it doesn’t mean you could successfully make a 65-foot-long loaf in a gigantic mega-oven.

Building up to a 1,250-litre reactor

Karthik Ramachandriya is a biochemical engineer and process development director at GreenLight. He holds up a small object, the size of a pen lid. “The first experiments were done in a 50-microlitre reactor,” he says—that is 0.05 millilitres, a barely visible quantity. “Then we scaled that up to 250ml.” He holds up a coffee cup. “It wasn’t that challenging, going from a microreactor to a coffee cup.” Then the team tried it in a bench-scale reactor that contained 10 litres. Finally, in 2019, the company started to build the Rochester plant, trying a 150-litre reactor and eventually a 1,250-litre one.

“We figured out how to do it all at the bench scale in Medford,” says Eric Otto, a biotechnologist and GreenLight’s vice president of manufacturing. But at both stages—making the plasmids and enzymes, and making the RNA—there were challenges associated with scaling up.

With enzyme and plasmid production, “our target audience was the good E. coli that we’re trying to make happy,” Otto says. “It’s like brewing beer, but a bit more complicated. You need to maintain what the organism needs and provide sufficient oxygen and other nutrients while removing the carbon dioxide so the fermentation doesn’t get sick.”

But maintaining those conditions is a different job in a 150-litre tank than it is in a one-litre one. “In the lab, you shake it in a tube,” says Shanebrook. “But at a manufacturing plant you can’t just shake it up when it’s a whole tank.”

“The mixing is different,” agrees Erin Cobb, a process engineer. “It’s not instantaneous any more. It’s not perfectly uniform. How you’re delivering oxygen to the cells is different; it’s easy at a small scale using bottled oxygen, but that is not economical when you scale up, and it’s a combustion risk, so you have to use pressurized air.” You can simply shake a one-litre flask to get all the nutrients to where they need to be, and the whole thing will automatically be at a uniform temperature. 

Pumps, fork trucks, and conveyor belts

Cobb adds that there are also logistical issues. If you’re adding a kilo of salt to a reactor, she says, “I can lift that with my hand. Can I do that with something 10 times bigger? I can pick up the 10-litre tank and dump it out; I can’t with the 1,000-litre. I need pumps, fork trucks, conveyor belts.”

Even prosaic tasks like cleaning become more complicated. “The spatula that I scooped the raw material into the small tank with,” she says: “I can take it over to the sink, wash it in the autoclave,” a machine that sterilizes equipment with steam. “You can’t put a 1,000-litre tank in an autoclave. You need a whole sterile system, you have to heat it to 120°C, you need sterilized air going into the system.”

There’s also a human resources issue. As the process becomes larger and reliant on many more skillsets, you need different kinds of labor. Setting up the Rochester plant was a case in point. “You need to know about utilities, fire alarms, sprinklers, heating, ventilation, floor drains,” says Shanebrook. “You’re dealing with hundreds of people in skilled trades. People who fix the roof, coat the floor.” 

Inspecting clear containers for formulations at GreenLight's Rochester, New York, manufacturing facility.
Inspecting clear containers for formulations at GreenLight’s Rochester, New York, manufacturing facility.

Within GreenLight itself, there are many brands of expertise—engineers, biotechnologists, chemists, entomologists, agronomists—all of whom need to understand each other’s specialty to some degree. “The most important thing in scaling up and scaling down is understanding the people who have worked on the process, being really comfortable asking them questions,” says Cobb. “Can I call anytime and ask, does this look weird? Is it supposed to look like this?” 

A plant that can scale up

There are other complications. Although the Rochester plant is a large targeted RNA manufacturing plant, it is itself a pilot for a much bigger facility—hundreds of times larger, 20,000 litres or more. So there’s no point solving a problem at a 150-litre scale if it wouldn’t then work at a much greater one. For instance, it might be easy to find ways to remove waste products from a one-litre tank, so that the bacteria can thrive. But unless the solution would also work at a much larger scale, then it’s not a solution at all. The pilot plant is designed as far as possible to mimic the realities of a larger, commercial plant. “You need to understand the limitations of a 20,000-litre reactor when we’re developing a process at a one-litre reactor,” says Ramachandriya.

“This is our playground,” says Shanebrook. “In the commercial plant, it’ll be designed for purpose: your pump goes from A to B, it’s dedicated to this function.

“But in the pilot plant, you don’t know what you need, and you need to accept that. You need to be flexible, use hoses that go from A to B, or A to C, or D to A. You take the changes in stride.”

When you do meet a problem in the pilot plant, says Ramachandriya, what’s important is going back to the smaller scales and understanding it properly. “If it’s a biological function, we go back to the tiny scale,” he says. “If it’s a process function, we do it at the coffee-cup or the one-litre size.” If your E. coli are unhappy and producing too much acid, you can probably explain that in the microreactor. If your pipes are clogging because the RNA solution gets too viscous, you’ll need the larger reactors, with their own pipes and pumps, to see where it’s going wrong.

GreenLight’s reactor energizes nucleotiodes

What’s also important as you scale up, says Ramachandriya, is keeping costs down. For instance, when you’re ordering thousands of litres of nucleotide solution or nutrients for your E. coli, you don’t want to be spending too much per litre. The nucleotides are made from yeast byproducts and energized by enzymes in GreenLight’s own reactor; they can be bought in bulk. “The yeast industry is very large and produces a variety of products from its specialized process, and we gain from the economies of scale,” says Otto.

Rows of clear bottles filled with formulations at GreenLight's Rochester manufacturing facility.
At GreenLight’s Rochester manufacturing facility, clear bottles are filled with formulations of RNA solutions.

Shanebrook adds that the scaling project isn’t done yet. You have to foresee future demand: if, as GreenLight hopes, its products become widely used, then even the planned 20,000-litre reactor will not be enough. “It’s reading the tea leaves and planning for expansion,” he says. “As the manufacturing person, you don’t want to be the limiting step. If the business side says, ‘We want a bigger plant,’ you want to be able to say, ‘We have a plan for this;’ it’s a common problem that business says we want this next month, and the technologists say it’ll take two years.”

At some point, scaling up further in a single plant becomes impossible. “In baking,” says Shanebrook, returning to his earlier metaphor, “sometimes you reach a scale, X number of tons, where you can’t scale up any more. Instead you number up.” That is, you build more plants, doing the same thing. It has advantages of redundancy in case of disaster.

GreenLight is not at that stage yet. But Shanebrook, in particular, is already thinking about ways to continue the scale-up process. At the moment, at each scale—whether 50-microlitre or 1,250-litre—the RNA is produced in batches: a reactor is filled with raw materials, left to do its thing, and the final product is harvested. But perhaps the future is continuous production: “You can put all that stuff in the pot of soup for three hours,” he says, “or you can have a long pipe that takes three hours to flow from the input to the output.” 

The ability to run continuously is a scenario for the future, he hopes. But the scale-up has already been spectacular, dealing in hundreds of thousands of times the volume the GreenLight team did just a few years ago. 

“It’s sort of like I sat with the home chefs,” says Cobb, “and then learned to cater the wedding.”

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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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