INDUSTRIAL IMPACT

Ribbon Biolabs Establishes IP Portfolio with First Granted U.S. Patent Covering Fast, Cost-Effective, Long DNA Synthesis Technology

Ribbon Biolabs | July 20, 2022 | Read time : 27:20 min

Ribbon Biolabs
Ribbon Biolabs, the DNA synthesis company, announced that the U.S. Patent and Trademark Office has issued U.S. Patent US 2020283756 A1, covering Ribbon Biolabs’ novel method for synthesizing a double stranded polynucleotide, also known as DNA, using a diverse library of oligonucleotides. The patent is the first of its submitted patent applications to be granted to the company, forming the foundation of its IP portfolio covering its long DNA synthesis technology.

Our novel method of fast, accurate, cost-effective DNA synthesis constitutes the basis of Ribbon Biolabs’ proprietary capabilities, and the grant of this patent serves as a validation of our highly differentiated solution for synthetic biology. Previous methods for automated DNA synthesis have been limited in their applicability due tob restricted lengths possible to produce and extended development timelines. We look forward to the further expansion of our intellectual property portfolio and our growing collaborations focused on driving innovation in the biotechnology, biopharma and academic research arenas.”

Harold P. de Vladar, CEO and founder of Ribbon Biolabs

Ribbon Biolabs’ novel approach to synthesizing DNA as described in the patent comprises a pre-built library of oligonucleotides, or shorter genetic sequences, that has been streamlined for efficient access, with reduced time and cost constraints that are further enhanced by an assembly workflow producing long polynucleotides accurately and without mismatches. This method optimizes the throughput time required to synthesize target DNA which has enabled the company to produce lengths beyond 10,000 base pairs efficiently and with high speed, including the recent successful synthetization of a 20,000 bp molecule for an undisclosed pharma client.

About Ribbon Biolabs
Ribbon Biolabs is a synthetic biology company advancing a new technology for the automated synthesis of long DNA molecules to enable innovation in the life sciences. With its proprietary technology in place, Ribbon Biolabs aims to be an inflection point in the continuing growth of the Bio-Economy by becoming the leading partner for long DNA molecules.

Spotlight

Your genome, every human's genome, consists of a unique DNA sequence of A's, T's, C's and G's that tell your cells how to operate. Thanks to technological advances, scientists are now able to know the sequence of letters that makes up an individual genome relatively quickly and inexpensively. Mark J. Kiel takes an in-depth look at the science behind the sequence.

Spotlight

Your genome, every human's genome, consists of a unique DNA sequence of A's, T's, C's and G's that tell your cells how to operate. Thanks to technological advances, scientists are now able to know the sequence of letters that makes up an individual genome relatively quickly and inexpensively. Mark J. Kiel takes an in-depth look at the science behind the sequence.

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MEDTECH

Solvias Acquires Cergentis to Bolster Biologics and Cell & Gene Therapy Capabilities

Solvias | July 18, 2022

Solvias, one of the world's leading independent pharmaceutical testing and manufacturing companies, announced today that it has acquired Utrecht, Netherlands-based Cergentis. The acquisition bolsters Solvias' platform of biologics and cell and gene therapy testing solutions. According to pharmaceutical market intelligence provider, Evaluate, global sales of cell and gene therapies are projected to accelerate at a 63% compound annual growth rate through 2026. As more researchers leverage emerging genetic engineering techniques to develop complex, novel medicines, they require sophisticated solutions to analyze their safety and effectiveness. With the addition of Cergentis, Solvias supports the increasing number of global pharmaceutical, biotech, and contract development and manufacturing organizations developing genetically engineered therapies with an expanded platform of testing services highlighted by a highly scientific team possessing advanced degrees and deep expertise steeped in emerging genome techniques and evolving regulatory requirements proprietary genomic analysis technology that delivers comprehensive data in a single experiment that enables effective decision-making and R&D program design a global network serving customers across three continents customized support for distinct genetic engineering applications, including cell and gene therapy, cell line development & genetically engineered models specialized knowledge in genomic sequencing of early-stage cell lines to support one of the first steps in the R&D process high-touch support encompassing end-to-end logistical services, digital project management and reporting capabilities to enable rapid turnaround time "We are relentlessly focused on ensuring the safety of new therapies in development. Cergentis is a cornerstone acquisition that expands our solutions supporting complex and emerging therapies. We will continue to pursue strategic acquisitions that add specialized capabilities to our offering and advance our goal of being a forerunner in our industry." Archie Cullen, CEO, Solvias Joris Schuurmans, CEO, Cergentis, added: "We are excited to become part of a global leader that complements our scientific expertise, innovation and customer service. Solvias and Cergentis share a deep commitment to providing our customers with the highest quality solutions and support to safely get their products into the hands of patients who need them." Effective immediately, Mr. Schuurmans will join Solvias' leadership team and continue to lead operations for Cergentis. Cergentis marks Solvias' second acquisition since partnering with health care investors Water Street Healthcare Partners and JLL Partners in 2020. The company has recruited industry leaders to join its board and commenced a program to significantly upgrade and expand its information technology platform and infrastructure to support its plans for global expansion. Financial terms of the acquisition are not being disclosed. Achelous Partners served as the advisor to Cergentis on the transaction. About Cergentis Cergentis is a trusted genomics-focused biotechnology company providing services and in-house solutions based on its proprietary genomic analysis platform to all leading biopharmaceutical companies and renowned research institutes. With widely published and recognized genetic analyses, Cergentis supports a global customer base in the characterization and QC of genetically engineered models, biopharmaceutical cell line development, and cell- and gene therapy products. By helping to de-risk R&D program decisions, minimizing time-to-clinic, providing objective genomic evidence for regulators, and supporting patient safety, Cergentis aims to support biopharmaceutical medicine development programs worldwide. About Solvias AG Solvias is a worldwide leader in contract research, development and manufacturing for the pharmaceutical, biotech, material science and cosmetic industries. Drawing on 20 years of scientific excellence, the company provides flexible and scalable analytical and manufacturing solutions that ensure the integrity of pharmaceutical and medical device products across their life cycle. Headquartered in Kaiseraugst near Basel, Switzerland, Solvias and its laboratories operate to the highest standards and in accordance with ISO, GMP, GLP and FDA regulations.

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INDUSTRIAL IMPACT

Heska to Acquire LightDeck Diagnostics to Invest in Manufacturing Capabilities and Accelerate Research and Development Efforts

LightDeck Diagnostics and Heska | September 13, 2022

Heska Corporation a leading global provider of advanced veterinary diagnostic and specialty solutions, announced today that the Company has entered a definitive agreement to acquire 100% of the share capital of MBio Diagnostics, Inc. d/b/a LightDeck Diagnostics a pioneer in innovative planar waveguide fluorescence immunoassay diagnostics with strong manufacturing and specialized production capabilities. Founded in 2009 and headquartered in Boulder, Colorado, LightDeck has developed a scalable and innovative platform for rapid and accurate point of care diagnostics. LightDeck's 80-member team includes industry veterans, engineers, and scientists, with deep technical expertise in assay development, manufacturing, and software development, who have collaborated with commercial, academic, and government partners worldwide to build an extensive intellectual property portfolio of 16 US patents and 15 international patents with broad applications, including in veterinary diagnostics, water testing, and human in-vitro diagnostics use. LightDeck's planar waveguide technology optimizes laser activated fluorescence and microfluidics to provide point of care cartridge-based testing without compromise, enabling reference lab-quality results in minutes with inexpensive, quantitative, and easy-to-use functionality. LightDeck's current Boulder location includes fully equipped laboratories for assay development and controlled manufacturing capabilities that support its new, state-of-the-art, highly automated facility in Longmont, Colorado, anticipated to go online in 2023 to dramatically scale-up capacity, production, and research and development. "We are thrilled to welcome the entire LightDeck team to Heska. We have known and closely followed their success for years and we are happy to fully join with them today as one team focused on supercharging their great work. LightDeck brings to Heska best-in-breed, highly scalable manufacturing and world-class assay development to help drive our strategies for winning at innovation and winning at scale," commented Kevin Wilson, Heska's Chief Executive Officer and President. "LightDeck was central in developing Heska's leading immunodiagnostic platform, Element i+®, including its current menu of Total T4, cTSH, Cortisol, and Progesterone. Having proven our capability, we now take this next important step as we aim to drive production of Element i+® analyzers and cartridges at scale and to accelerate key test menu expansion, such as our recently announced Nu.Q® Vet Cancer Screen, cCRP, SDMA, infectious diseases, and more, in single and multi-plex formats that are substantially better than the competition. We expect to drive gross margin improvement with new manufacturing capabilities and scaling across the business. The addition of LightDeck is a great strategic, financial, and cultural fit with Heska as we continue our march to the top of the innovation and manufacturing competition for the most valuable diagnostics," concluded Mr. Wilson. "This is a terrific outcome for LightDeck and Heska and their shareholders, employees and commercial partners. We have known and worked with Heska for years and we greatly admire the Heska organization. Since its founding in 2009, LightDeck has been dedicated to revolutionizing testing at the point of care- for faster, more accurate, less expensive, multi-plex testing of the most important diagnostic tests. We have developed one of the most innovative and technologically-advanced assay platforms in the world, which has led to our recent addition to Fast Company's Annual List of the World's 50 Most Innovative Companies for 2022. I am very proud of the work our team has accomplished over the last 13 years." LightDeck's Co-Founder and Chief Technology Officer, Mike Lochhead, went on to say, "We are excited to now enter this next phase with Heska to dramatically expand our reach and scale. What we do at LightDeck matters a great deal. With Heska, we go confidently into our next commercial, manufacturing, and development chapters, strongly engaged, highly supported, and clearly set-up for long-term success and growth." Nick Traggis, LightDeck's Chief Executive Officer About Heska Heska Corporation manufactures, develops and sells advanced veterinary diagnostics, informatics, and specialty healthcare solutions through its two business segments: North America and International. Both segments include Point of Care Lab testing instruments and consumables, digital imaging products, software and services, data services, allergy testing and immunotherapy, and single-use offerings such as in-clinic diagnostic tests and heartworm preventive products. The North America segment also includes private label vaccine and pharmaceutical production for third-parties, primarily for herd animal health. About LightDeck Diagnostics LightDeck Diagnostics believes in a new approach to healthcare, where quick and accurate diagnostic tests will be run wherever and whenever they are needed. The company's proprietary LightDeck® platform combines an advanced laser waveguide with novel materials and patented manufacturing techniques to deliver lab-quality results anywhere, in minutes. The LightDeck platform is achieving success in veterinary diagnostics and for environmental testing. LightDeck is also developing a portfolio of in vitro diagnostic panels. The company is based in Boulder, Colorado, and is recognized as Colorado BioScience Association's Company of the Year, 2021.

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MEDTECH

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

Samsung Biologics | August 02, 2022

GreenLight Biosciences a biotechnology company dedicated to making ribonucleic acid products affordable and accessible for human health and agriculture, and Samsung Biologics 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," 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.

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