Outsourcing biology CRO and preclinical research studies during COVID19 pandemic

PR Newswire | May 15, 2020

While the COVID-19 pandemic continues to evolve, many Cancer Research Institutions and Pharma/Biotech companies are considering how to restart the biomedical research and drug development programs. This may include thinking through meeting the timeline, risk of mitigation actions, and possible program reprioritizations as components of the strategy to return to normal operations. Our preclinical services allow scientists to discover new innovative therapies effective in serious diseases without known treatment. Science never stops. All of us at Altogen Labs are committed to help advancing biomedical research to improve human health. We developed an Instant Online Quote tool to advance research program planning and scheduling. Scientists can select experimental variables (such as strain, number of treatment and control groups, treatment frequency, route of test article administration, etc) and generate an instant quotation for the project. Efficacy and safety toxicology studies are supported by our in-house bio-imaging, histopathology, PK/PD biochemistry, protein and gene expression analysis capabilities. Efficacy and toxicology studies play a significant role in preclinical drug development and involve in vivo pharmacokinetic testing in animal models after the positive results were obtained during preclinical in vitro testing. Altogen Labs offers over 90 xenograft cancer research models and preclinical pharm/tox IND studies. Our animal facility was established in 2009 and offers a number of IACUC regulated efficacy and safety services (IND). Most work is performed on contract basis and 100% of IP belongs to the client. Working with a number of tumorigenic cell lines and associated xenograft models we developed expertise ensuring good results both in terms of tumor take and functional tumor growth inhibition by known chemotherapy and experimental test compounds.

Spotlight

Big changes are coming to the neuropathic pain market – are you prepared? Take a look at the projected neuropathic pain drug sales for the US, Japan, and five EU nations with the latest infographic from Datamonitor Healthcare. This snapshot view of the future of the neuropathic pain market is packed with data from the full Datamonitor Healthcare Neuropathic Pain Disease Coverage report.

Spotlight

Big changes are coming to the neuropathic pain market – are you prepared? Take a look at the projected neuropathic pain drug sales for the US, Japan, and five EU nations with the latest infographic from Datamonitor Healthcare. This snapshot view of the future of the neuropathic pain market is packed with data from the full Datamonitor Healthcare Neuropathic Pain Disease Coverage report.

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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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INDUSTRIAL IMPACT

Active Motif and EpiCypher Execute Cross-Licensing Agreement and End Ongoing Litigation Involving Targeted Transposition Technology for Epigenomics

EpiCypher and Active Motif | August 01, 2022

CUT&Tag is a targeted transposition technique that allows high-resolution genomic mapping of histone modifications and chromatin-associated proteins through the precise insertion of DNA sequences into the genome using the Tn5 transposase enzyme. EpiCypher and Active Motif each own or control patents covering complementary aspects of targeted transposition. Active Motif and EpiCypher have leveraged their respective IP to independently create successful genomic mapping tools that allow researchers to employ targeted transposition / CUT&Tag for advanced epigenomics research. Since 2020, there has been a patent dispute between the companies that culminated in patent infringement litigation. EpiCypher and Active Motif have recently agreed to put their differences aside and today announced the signing of a global settlement ending the ongoing litigation, and a mutual cross-licensing agreement of their respective intellectual property. These developments will effectively resolve all outstanding legal issues between the two companies in the targeted transposition / CUT&Tag space. The companies agreed that both Active Motif and EpiCypher's IP are equally valid, and that both sets of IP are required to commercialize products and services that use technology involving targeted transposition techniques such as CUT&Tag. As part of the cross-licensing agreement, EpiCypher and Active Motif each agreed to provide to the other company a non-exclusive, royalty-bearing license to enable commercialization of products, kits, and services that use targeted Tn5 / CUT&Tag-based workflows. The companies also agreed to pool their IP and work together to sublicense targeted tagmentation technology for emerging fields of use, including single cell and spatial genomics assays. This places Active Motif and EpiCypher in a very strong position in the targeted transposition market. "Today's announcement is great for EpiCypher, Active Motif, and our collective customers", said Dr. Martis Cowles, Chief Business Officer of EpiCypher. "The Partnership between EpiCypher and Active Motif is a natural fit, and we look forward to working with Active Motif to maximize the impact of CUT&Tag technology on chromatin science and drug development". "Targeted transposition technology has become increasingly important in simplifying the study of Protein-DNA interactions. We are pleased to be collaborating with EpiCypher to bring targeted transposition to the research and biotech communities." Ted DeFrank, President and CEO of Active Motif. Joe Fernandez, the Founder of Active Motif About EpiCypher EpiCypher® is dedicated to developing transformative epigenetic solutions that advance the science of epigenetic regulation and improve human health. Most recently, EpiCypher has been at the leading edge of chromatin profiling technology with highly sensitive CUTANA™ epigenomic mapping assays for ChIC, CUT&RUN, and CUT&Tag. The Company also manufactures and sells the largest collection of defined "designer" nucleosomes on the market and offers a range of high-throughput nucleosome-based assays and services for chromatin research and drug development. About Active Motif Active Motif, Inc. is dedicated to developing, manufacturing and delivering epigenetics-based research tools to analyze nuclear function. Its customers include scientists from academic and government institutions; biotechnology and pharmaceutical companies. Active Motif operates globally through its corporate headquarters in Carlsbad, California and offices in Shanghai China, Tokyo Japan and Waterloo Belgium. Active Motif applies a multi-disciplinary approach to create new and modify existing technologies to meet the current and future needs of life science researchers.

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INDUSTRIAL IMPACT

AbCellera and Atlas Venture Collaborate to Empower the Development of Impactful Medicines for Patients

AbCellera and Atlas Venture | August 04, 2022

AbCellera and Atlas Venture announced a multi-target partnership to discover therapeutic antibodies for up to three drug targets that can be developed and commercialized by a stealth-stage Atlas-backed company. The collaboration leverages Atlas’ proven track record in forming innovative biotechnology companies and AbCellera’s unique ability to quickly deliver lead drug candidates to bring transformational new medicines to patients faster. "AbCellera’s clinically validated platform lets us start discovery in a virtualized model that aligns well with our capital efficient investment strategy. This partnership supports our approach to value creation by allowing us to focus on building companies that aim to deliver impactful medicines to patients.” Steven Robinette, Ph.D., Venture Partner at Atlas Venture “Atlas has proven expertise in finding and transforming innovative scientific research into exciting new biotechs,” said Carl Hansen, Ph.D., CEO and President of AbCellera. “By eliminating their need to build internal antibody discovery capabilities at inception, we provide newly launched biotech ventures with a competitive advantage that empowers them to move faster and increase their probability of success. We look forward to working alongside Atlas’ entrepreneurs to unlock their breakthrough science and create new therapies for patients in need.” Under the terms of the agreement, Atlas’ portfolio company will have the right to develop and commercialize therapeutic antibodies resulting from the collaboration. AbCellera will receive research payments and will be eligible to receive clinical and commercial milestone payments and royalties on net sales of products. About Atlas Venture Atlas Venture is a leading biotech venture capital firm. With the goal of doing well by doing good, we have been building breakthrough biotech startups for over 25 years. We work side by side with exceptional scientists and entrepreneurs to translate high impact science into medicines for patients. Our seed-led venture creation strategy rigorously selects and focuses investment on the most compelling opportunities to build scalable businesses and realize value. About AbCellera Biologics Inc. AbCellera is a technology company that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. AbCellera partners with drug developers of all sizes, from large pharmaceutical to small biotechnology companies, empowering them to move quickly, reduce cost, and tackle the toughest problems in drug development.

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