FUJIFILM Diosynth Biotechnologies Enters Strategic Partnership With OXGENE™ To Address Supply Bottlenecks In Gene Therapy Development & Manufacturing

FUJIFILM Diosynth Biotechnologies | April 23, 2020

FUJIFILM Diosynth Biotechnologies (FDB), a world leading cGMP Contract Development and Manufacturing Organization (CDMO) supporting its partners in the biopharmaceutical industry with the development and production of their biologics, vaccines and gene therapies, announced a strategic partnership with OXGENE™, an industry leader in the design and development of gene therapy technologies. This partnership will enable FDB to deliver gene therapy products to clients with an approximate 25% lead-time reduction. FDB has licensed OXGENE's proprietary AAV system for commercial use, to support biotech companies engaged in gene therapy development and manufacture. The AAV system consists of Helper, Rep/Cap and Gene of Interest plasmids, used in combination with a clonal suspension a HEK293 cell line. Every aspect of OXGENE's AAV system, including reconfiguration of the Rep and Cap genes, and clonal cell line selection, has been optimised for maximum AAV yield. FDB will manufacture and stock a supply of Helper and Rep /Cap plasmids for clients engaged in process development and GMP manufacture of gene therapy programs at FDB's College Station, Texas site. Gene of Interest (GOI) plasmid manufacture will be performed in-house using FDB's existing leading microbial capabilities and facilities with cGMP manufacture planned to commence in Q4 2020.

Spotlight

Stem cell therapy may soon become a go-to treatment option for patients with rheumatoid arthritis (RA) and similar autoimmune conditions.

Spotlight

Stem cell therapy may soon become a go-to treatment option for patients with rheumatoid arthritis (RA) and similar autoimmune conditions.

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INDUSTRIAL IMPACT

BioAuxilium Research Expands its No-Wash THUNDER™ TR-FRET Cell Signaling Assay Portfolio

BioAuxilium Research Inc. | February 10, 2022

At the annual Society for Laboratory Automation and Screening International Conference and Exhibition in Boston, BioAuxilium Research Inc., a biotech tool company focused on facilitating access to fully validated assay kits to the biomedical research community, today announced the expansion of its no-wash THUNDER™ time-resolved Förster resonance energy transfer technology portfolio by introducing new cell signaling pathway and biomarker research assay kits, along with a panel of “mix and match” toolbox reagents. The new offerings bring the company’s portfolio to a total of 104 products. Developed and manufactured at BioAuxilium’s laboratories, the new THUNDER™ TR-FRET assay kits are ideal for studying intra- or extra-cellular signaling pathways and include key human kinases, pro-inflammatory cytokines, and a cAMP detection kit designed for the screening and characterization of G‑protein coupled receptors (GPCRs). The THUNDER™ TR-FRET toolbox reagents include europium and far-red labeled anti-species, anti-epitope, and streptavidin for enabling easy in-house assay development. “The addition of the new THUNDER™ TR-FRET assays and reagents demonstrate our capacity to continue to grow a focused portfolio of high quality yet affordable assays for both basic research and drug discovery. In addition, we are committed to addressing the reproducibility crisis in biomedical research by continuing to provide reliable research tools that enable the generation of highly reproducible results, much faster.” Jaime Padros, PhD, President, BioAuxilium Research BioAuxilium’s THUNDER™ TR-FRET technology is a robust, proprietary platform based on a FRET pair showing an enhanced spectral compatibility and TR-FRET signal, optimal antibody pairs selected specifically for TR-FRET, and a panel of optimized lysis and assay buffers. In addition, all assays use a simplified protocol that dramatically decreases hands-on time and assay variability and is easily amenable to automation for high-throughput screening. All THUNDER™ TR-FRET products are extensively validated to ensure specificity, sensitivity, and reproducibility using real-life biological samples. About BioAuxilium Research Inc. BioAuxilium is a private Canadian biotechnology tool company founded by expert assay scientists. It focuses on developing and manufacturing top-quality, highly validated assay kits that accelerate biomedical research. BioAuxilium’s kits are based on its enhanced proprietary THUNDER™ TR-FRET technology. They are offered at an outstanding value and are accompanied by information-rich datasheets and expert technical support. Bioauxilium also provides customized services in assay development using diverse technologies on a contract basis.

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CELL AND GENE THERAPY

MUSC and Helix launch In Our DNA SC, first-of-its-kind population genomics program to drive preventive, precision health care for South Carolinians

Helix | September 21, 2021

The Medical University of South Carolina (MUSC) and Helix have announced a strategic collaboration to develop a first-of-its-kind population genomics initiative in South Carolina called In Our DNA SC. The large-scale program is designed to improve health care outcomes by integrating genetic insights into clinical care and research. The statewide initiative will enroll 100,000 patients in genetic testing over the next four years at no cost to the patient. The program will enable the use of genomic insights with an initial focus on actionable information regarding a patient's risk for certain forms of cancer and cardiovascular disease. The genetic reports will allow patients and their health providers to develop precision health care plans to proactively mitigate the conditions and take a more preventive approach to patient care. Patient enrollment in In Our DNA SC is expected to begin in the fall. Medical University of South Carolina and Helix to develop a first-of-its-kind genomics initiative called In Our DNA SC. In addition, MUSC and Helix will be developing a robust clinico-genomic dataset from consenting participants that will help researchers learn what can cause certain diseases, how we may be able to treat them more effectively and, possibly, improve the standard care for everyone. This is expected to lay the groundwork for a broader collaboration with other organizations across the health care value chain. As South Carolina's only comprehensive academic health sciences center, delivering the highest quality care throughout the state is our top priority. Precision medicine is an emerging field that is going to transform the future delivery of health care. Being a leader and helping to define this path is core to our mission. We are excited to have the opportunity to partner with Helix to deploy this first-of-its-kind population genomic program for our patients. This collaboration will help drive preventive, precision health care for South Carolinians. - David J. Cole, M.D., FACS, MUSC president The strategic relationship with Helix allows MUSC to leverage Helix's unique Sequence Once, Query Often™ model and its end-to-end integration platform to enable immediate application and continual on-demand use of genetic insights throughout a patient's life. By working with South Carolina's only integrated academic health sciences center in the state, Helix gains access to thousands of providers and research staff dedicated to understanding how to deliver the highest quality patient care available to serve the people of South Carolina and beyond. Enrollment in the program will initially be available to patients who sign up at select MUSC clinics and locations, later expanding to participants throughout the community and state in collaboration with MUSC's clinical affiliates and partners. Additionally, participants who consent to securely contribute their genetic data will help MUSC develop one of the largest clinico-genomic datasets in the country. Analyses from this platform will be used to pioneer and further advance genomics research. About the Medical University of South Carolina Founded in 1824 in Charleston, MUSC is home to the oldest medical school in the South as well as the state's only integrated academic health sciences center, with a unique charge to serve the state through education, research and patient care. Each year, MUSC educates and trains more than 3,000 students and nearly 800 residents in six colleges: Dental Medicine, Graduate Studies, Health Professions, Medicine, Nursing and Pharmacy. MUSC brought in more than $271 million in biomedical research funds in fiscal year 2020, continuing to lead the state in obtaining National Institutes of Health funding, with more than $129.9 million. As the clinical health system of the Medical University of South Carolina, MUSC Health is dedicated to delivering the highest quality and safe patient care while training generations of compassionate, competent health care providers to serve the people of South Carolina and beyond. Close to 25,000 care team members provide care for patients at 14 hospitals with approximately 2,500 beds and 5 additional hospital locations in development, more than 300 telehealth sites and nearly 750 care locations situated in the Lowcountry, Midlands, Pee Dee and Upstate regions of South Carolina. In 2021, for the seventh consecutive year, U.S. News & World Report named MUSC Health the No. 1 hospital in South Carolina.MUSC and its affiliates have collective annual budgets of $4.4 billion. The more than 25,000 MUSC team members include world-class faculty, physicians, specialty providers and scientists who deliver groundbreaking education, research, technology and patient care. About Helix Helix is the leading population genomics company operating at the intersection of clinical care, research, and genomics. Its end-to-end platform enables health systems, life sciences companies, and payers to advance genomic research and accelerate the integration of genomic data into clinical care. Powered by one of the world's largest CLIA / CAP next-generation sequencing labs and the first and only FDA authorized whole exome sequencing platform, Helix supports all aspects of population genomics including recruitment and engagement, clinically actionable disease screening, return of results, and basic and translational research. In response to the COVID-19 public health crisis, Helix has launched a sensitive and scalable end-to-end COVID-19 test system to meet the needs of health systems, employees, governments, and other organizations across the country.

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CELL AND GENE THERAPY

Kaneka Eurogentec Announces the Successful Production of 25g of mRNA in One Batch

Kaneka Eurogentec | February 23, 2022

Kaneka Eurogentec, an FDA inspected contract development and manufacturing organization announced today that its mRNA manufacturing facility has successfully produced a 25 g batch of mRNA for a US customer. Eurogentec’s GMP mRNA manufacturing service offers in vitro transcription (IVT), purification, quality control and batch release of GMP material up to 25 g scale in its current facility in Belgium. In this project Eurogentec successfully produced and purified 25 g of material in one batch that will be tested by the customer. This quantity is equivalent to 100,000’s to millions of doses of mRNA, potentially sufficient for late clinical and commercial uses. Ingrid Dheur, Vice President Biopharma Development at Kaneka Eurogentec stated, “This successful production confirms our ability to produce mRNA at large scale and with a quantity and purity level that exceeds the targets requested by the customer.” “The rapid growth in cell and gene therapy products is driving the need for plasmid DNA and mRNA production. Our existing pharma and biotech customers have already expressed the need for such large-scale manufacturing capabilities, and we have developed methods to respond to these needs. Additionally, we are currently in the planning stages for a 2nd manufacturing facility to further expand our GMP mRNA manufacturing offering”. Lieven Janssens, President and CEO at Kaneka Eurogentec About mRNA Messenger RNA (mRNA) is a molecule that encodes for a protein which will have a beneficial effect in patients. Rather than producing complex proteins, producing mRNA is a convenient way to deliver the protein as a precursor. The production of mRNA is much simpler than producing a recombinant protein and thus mRNA molecules have the advantage of enabling a shorter production time to clinic. For example, current mainstream therapies for the protection against COV-SARS-2 infections are based on mRNA and have been developed in record time. The success of these COVID-19 mRNA vaccines has opened the evaluation of mRNA for other infectious diseases, for example influenza or HIV, and the need for custom large-scale production of GMP mRNA. About Kaneka Eurogentec Eurogentec was founded in 1985 as one of the first biotech companies in Belgium. Kaneka Eurogentec contributes to improving health and fighting diseases by supplying products and services to scientists involved in life science research, molecular diagnostics, and therapeutic developments. The Liège-based company is recognized as one of the major suppliers in the field of genomics and proteomics as well as a trusted Contract Development and Manufacturing Organization (CDMO) for the bio-production of pharmaceuticals. Eurogentec is one of a few CDMOs capable of manufacturing GMP oligonucleotides, mRNA, plasmid DNA and recombinant proteins for human injectable use, with commercial products sold in USA, Europe and Japan. In 2010, Eurogentec, renamed Kaneka Eurogentec in April 2017, became part of Kaneka Corporation, a large Japanese chemical company focusing on technology and innovation. About Kaneka Corporation Kaneka is an innovation-oriented chemical company. Traditionally the company has been active in polymers, fermentation, biotechnology, and electronics, as well as other fields. Business activities now span a broad spectrum of markets ranging from plastics, EPS resins, chemicals and foodstuffs to pharmaceuticals, medical devices, electrical and electronic materials, and synthetic fibers. The life science related activities are currently one of the strategically important domains for Kaneka. The company has been a pioneer among Japanese chemical companies in establishing overseas operations, beginning in 1970 with a subsidiary in Belgium.

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