Life Science News

  • 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

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
dpesci@greenlightbio.com
For press, email: press@greenlightbio.com
For investors, email: investors@greenlightbio.com

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
cair.kim@samsung.com

Notes to editors

  1. GreenLight and Samsung Biologics announced their partnership in December 2021:
    https://greenlightbiosciences.com/greenlight-biosciences-and-samsung-biologics-announce-collaboration/

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5f22986d-9b95-4bf5-9d6f-334ea48f22ba


Primary Logo

News Provided by GlobeNewswire via QuoteMedia

GRNA
GreenLight Biosciences Announces Second Quarter 2022 Financial Results and Highlights Recent Company Progress

GreenLight Biosciences Announces Second Quarter 2022 Financial Results and Highlights Recent Company Progress

GreenLight Biosciences (Nasdaq: GRNA), a public benefit corporation striving to bring effective and safe solutions to make food clean and affordable for everyone and dedicated to developing health solutions for every person in our planet, today reported operational highlights and financial results for the second quarter ended June 30, 2022.

"GreenLight's RNA platform has continued to prove its value for developing a wide range of solutions to feeding the world and keeping it healthy. We founded GreenLight to change the world, and we have continued to make progress this quarter," said Andrey Zarur, CEO of GreenLight. "Today, we are pleased to announce a capital infusion of $108.4 million. We are grateful for the support, continued faith, and trust of our longtime investors. We also welcome new investors who have decided to join GreenLight in our mission to help feed the world and keep it healthy. This will allow us to continue to make progress across our pipeline.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
GreenLight Biosciences announces $109 million financing

GreenLight Biosciences announces $109 million financing

GreenLight Biosciences (Nasdaq: GRNA), a public benefit corporation striving to bring effective and safe solutions to make food clean and affordable for everyone and dedicated to developing health solutions for every person on our planet, today announced a private placement of approximately $109 million.

"GreenLight's RNA platform has continued to prove its value as our research and development addresses a wide range of solutions to the world's challenges," said Andrey Zarur, CEO of GreenLight. "We are grateful for the support, conviction, and trust of our returning investors. We are also delighted to welcome new investors who have decided to join GreenLight in our mission to feed the world and keep it healthy.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
NIH, GreenLight Biosciences to collaborate on COVID-19 vaccine development for new variants

NIH, GreenLight Biosciences to collaborate on COVID-19 vaccine development for new variants

GreenLight Biosciences has announced a collaboration with the National Institutes of Health (NIH) to develop COVID-19 vaccines that are more broadly protective against new variants and with longer-lasting effects.

"This is a tremendous opportunity for us to partner with a premier vaccine discovery team and use our mRNA platform to accelerate the development of coronavirus vaccines which are more broadly protective and durable than those currently available," says Amin Khan, PhD, GreenLight's Chief Science Officer, Human Health.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Cybin Announces Results of Shareholders' Meeting

Cybin Announces Results of Shareholders' Meeting

Cybin Inc. ( NEO:CYBN ) (NYSE AMERICAN:CYBN) (" Cybin " or the " Company "), a biopharmaceutical company focused on progressing "Psychedelics to Therapeutics TM ", is pleased to announce the voting results for each of the matters presented at the Company's annual meeting of shareholders held on August 15, 2022 (the " Meeting "). There were 71 shareholders represented in person or by proxy at the Meeting holding 47,019,721 common shares, representing 28.3% of Cybin's total issued and outstanding common shares as at the record date for the Meeting. The voting results for each matter presented at the Meeting is set out below:

1. Appointment of Auditor

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Ginkgo Bioworks Reports Second Quarter 2022 Financial Results

Ginkgo Bioworks Reports Second Quarter 2022 Financial Results

$145 million of Total revenue in Q2 2022, representing 231% growth over Q2 2021

13 new Cell Programs added in Q2 2022, representing 86% growth over Q2 2021

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Ginkgo Bioworks and XpresCheck Receive Award to Expand CDC's Traveler-Based SARS-CoV-2 Genomic Surveillance Program In U.S. Airports

Ginkgo Bioworks and XpresCheck Receive Award to Expand CDC's Traveler-Based SARS-CoV-2 Genomic Surveillance Program In U.S. Airports

Ginkgo Bioworks (NYSE: DNA ) and XpresSpa Group, Inc. (Nasdaq: XSPA) announced they will continue to support the Centers for Disease Control and Prevention's (CDC's) traveler-based SARS-CoV-2 genomic surveillance program through a new contract awarded August 12, 2022. The partnership is expected to support public health and biosecurity services totaling approximately $16 million, with an overall potential to exceed $61 million based on CDC program options and public health priorities. As COVID-19 sublineages and other biological threats continue to emerge, the partners plan to expand the program footprint and incorporate innovative modalities and offerings, such as monitoring of wastewater from aircraft lavatories.

Concentric by Ginkgo, the biosecurity and public health initiative of Ginkgo Bioworks, XpresCheck by XpresSpa Group, a leading provider of COVID-19 surveillance and diagnostic testing in U.S. airports, and CDC have partnered since August 2021 to deliver timely public health data on SARS-CoV-2 variants and their sublineages, including the first U.S. detections of Omicron BA.2 and BA.3 . The expanded program will serve as an early warning system to detect new or emerging SARS-CoV-2 variants, and can facilitate response to future travel-associated outbreaks and pandemics. It provides a pulse of COVID-19 cases and the arrival of variants among international travelers, delivering important data as the country monitors the global COVID-19 situation.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Clene Reports Second Quarter 2022 Financial Results and Recent Operating Highlights

Clene Reports Second Quarter 2022 Financial Results and Recent Operating Highlights

  • Topline results from the Phase 2 VISIONARY-MS clinical trial with CNM- Au8 ® met the primary and secondary endpoints of Low Contrast Letter Acuity (LCLA) and modified Multiple Sclerosis Functional Composite (mMSFC) compared to placebo over 48 weeks in the mITT population
  • Updated data from RESCUE-ALS demonstrate a statistically significant decrease in mortality in participants who entered open-label extension study ( 5 CNM-Au8 deaths vs. 14 placebo deaths, HR=0.301, p=0.0143)
  • Topline results from HEALEY ALS Platform Trial expected this quarter
  • Cash, cash equivalents and marketable securities of $26.3 million as of June 30, 2022
  • Entered into a $3.0 million loan facility from State of Maryland to support development of commercial manufacturing facility

Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease, today reported its second quarter 2022 and recent operating highlights.

"We are on the cusp of a transformative period for the Company as we await a key data readout in ALS for our lead asset, CNM-Au8 ® ," said Rob Etherington, President and CEO of Clene. "The ALS patient population is desperate for new treatments to help mitigate the disease course and following the statistically significant survival benefits demonstrated in our open label trial, we are hopeful that we can deliver an effective therapy for people living with ALS."

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Clene Reports Positive Topline Results for CNM-Au8® in the Phase 2 VISIONARY-MS Trial in Multiple Sclerosis

Clene Reports Positive Topline Results for CNM-Au8® in the Phase 2 VISIONARY-MS Trial in Multiple Sclerosis

  • CNM-Au8 met primary and secondary endpoints of Low Contrast Letter Acuity (LCLA) and modified Multiple Sclerosis Functional Composite (mMSFC) compared to placebo over 48 weeks in the mITT population

  • Consistent improvements favoring CNM-Au8 were seen across paraclinical biomarkers, providing physiological evidence for its potential neuroprotective and remyelinating effects

  • CNM-Au8 treatment was well-tolerated, and there were no significant safety findings reported

  • Results provide support to advance CNM-Au8 into Phase 3 clinical development

  • Clene to host a call and webcast at 7:30 am EDT today

Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, today announced positive topline results from the Phase 2 VISIONARY-MS trial of CNM-Au8 ® an investigational gold nanocrystal suspension, in participants with stable relapsing remitting multiple sclerosis (RRMS).

VISIONARY-MS was a Phase 2 proof-of-concept, multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of CNM-Au8 (15 mg or 30 mg daily) as adjunctive therapy to currently available disease-modifying therapies (DMTs) versus placebo over 48 weeks in stable RRMS participants with chronic optic neuropathy.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Clene to Host VISIONARY-MS Results Call and Webcast on August 15

Clene to Host VISIONARY-MS Results Call and Webcast on August 15

Clene Inc. (NASDAQ: CLNN) along with its subsidiaries "Clene" and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease, today announced that it will present results from its Phase 2 VISIONARY-MS trial at 7:30 a.m. EDT on Monday, August 15.

Conference Call and Webcast Details:
Presentation Time: 7:30 a.m. EDT on August 15, 2022
Investors (Toll free): 1 (888) 770-7152
Conference ID: 5318408
Webcast link

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×