Transcriptomic Switch Turns Healthy Liver Tissue Cancerous

Technology Networks | December 17, 2019

By combining RNA sequencing, bioinformatics and mathematical modeling, University of California San Diego School of Medicine and Moores Cancer Center researchers identified a sudden transcriptomic switch that turns healthy liver tissue cancerous. The finding was used to develop a quantitative analytical tool that assesses cancer risk in patients with chronic liver disease and to predict tumor stages and prognosis for patients with liver cancer. In the December 16, 2019 online edition of the Proceedings of the National Academy of Science (PNAS), Gen-Sheng Feng, PhD, professor of in the Department of Pathology and Section of Molecular Biology, Division of Biological Sciences at UC San Diego, and team describe developing a tumorigenic index score that identifies a shift from healthy to malignant cells

Spotlight

Single-use technology (SUT) products are widely accepted for the manufacturing of vaccines and biologics. The increase in adoption of single-use Thermo Scientific™ BioProcess Containers (BPCs) is a result of their demonstrated performance, and their cost- and timesaving benefits. The quality and purity of the plastics used to produce Thermo Scientific™ Single-Use Bioreactor (S.U.B.), Single-Use Mixer (S.U.M.), and Single-Use Fermentor (S.U.F.) BPCs and storage bags are crucial to the purity and efficacy of final biopharmaceutical drug products.


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MEDICAL

ABC Opens Commercial MEL BioSurfactant Production in Irvine, CA

ABC | May 19, 2022

Advanced BioCatalytics (ABC) is pleased to announce the opening of our new biosurfactant commercial pilot plant in Irvine California. The plant reflects the successful collaboration of the ABC R&D team and Dr. Wenjie Xia, professor of Microbiology at Nankai University in Tianjin China. The commercial pilot plant is the first step in commercial scale up of new glycolipid (biosurfactants) and is the first plant to produce commercial quantities of mannosylerythritol lipids (MEL) in North America. ABC pioneered the use of microbiology to produce metabolites and sustainable chemistry in 1996. Our products are used in water treatment, the energy sector, for agriculture uses, and in personal and home care applications. By using microbiology, we can create natural alternatives to petrochemicals. For our production we upcycle waste feed stocks such as used vegetable oils or other sources of bio-waste material. As a result, our chemistry also offers an alternative to plant based materials which have the unfortunate reliance on certain plant species which are contributing to global deforestation and destruction of biodiversity. The MEL material can be used in a variety of ways in the homecare and personal care sectors. MEL is free of 1,4 dioxane, mild on the skin, and produces minimal foam. This superfatting agent is ideal for delivering moisture in personal care products and can be used along with anionic and amphoteric surfactants for improved efficacy. The addition of MEL production compliments ABC's rhamnolipid and BioSS RL fermactant production. About Advanced BioCatalytics: Advanced BioCatalytics is an industrial biotechnology company that leverages its innovative Fermactant technology for applications in the Home and Personal Care, Energy, Agriculture, and Wastewater markets. These products have demonstrated the ability to be highly cost-effective, without depending on harmful chemistries such as caustics, acids or dangerous solvents, which can be harmful to the user and/or the environment. Advanced BioCatalytics was founded in 1996 and we are excited to be introducing a new technology that will change the future performance, and cost, of the world's cleaning products.

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DIAGNOSTICS

Biodesix Announces Research Agreement with Top US Cancer Center

Biodesix | June 06, 2022

Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, today announced that it intends to develop a new novel minimal residual disease (MRD) test as a part of a master sponsored research agreement (MSRA) with Memorial Sloan Kettering Cancer Center (MSK). In addition, the MSRA between MSK and Biodesix also includes the potential future development of other diagnostic tests aimed at improving the treatment of cancer. The initiation of this research program with MSK is a significant milestone for Biodesix. While the initial focus will be on developing a novel MRD test for solid tumors as an addition to our pipeline, Biodesix hopes to co-develop and validate a number of new test concepts under the agreement.” Scott Hutton, CEO, Biodesix. Biodesix will utilize its array of genomics, proteomics, artificial intelligence, and machine learning capabilities with the aim of developing and commercializing oncology biomarker assays in collaboration with MSK. Initially, the teams will collaborate to develop a highly sensitive molecular MRD test on the new ddPCR™ platform, the Bio-Rad QX600™ ddPCR™ System. As part of Bio-Rad's continued growth in oncology and expansion into the field of molecular MRD monitoring, we are pleased that Biodesix is utilizing the advanced multiplexing QX600™ ddPCR™ System that will be launching later this year." Simon May, EVP & President, Life Science Group, Bio-Rad Laboratories. About Biodesix Biodesix is a leading data-driven diagnostic solutions company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix is the first company to offer eight non-invasive tests for patients with lung diseases. The blood based Nodify Lung® nodule risk assessment testing strategy, consisting of the Nodify XL2® and the Nodify CDT® tests, evaluates the risk of malignancy in incidental pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. The blood based IQLung™ strategy for lung cancer patients integrates the GeneStrat ddPCR™ test, the GeneStrat NGS™ test and the VeriStrat® test to support treatment decisions across all stages of lung cancer with results in an unprecedented 36-72 hours, expediting time to treatment. Biodesix also leverages the proprietary and advanced Diagnostic Cortex® AI (Artificial Intelligence) platform, to collaborate with many of the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease. Biodesix launched the SARS-CoV-2 ddPCR™ test, the Platelia SARS-CoV-2 Total Ab, and the cPass™ SARS-CoV-2 Neutralization Antibody test (cPass™ Neutralization Test Kit, GenScript, Inc,) in response to the global pandemic and virus that impacts the lung and causes COVID-19

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DIAGNOSTICS

Exothera announces industrial scale AAV manufacturing collaboration with LogicBio Therapeutics and Polyplus

Exothera | June 15, 2022

Exothera SA today announced a collaboration with LogicBio® Therapeutics and Polyplus-transfection® SA. for the development of a highly scalable AAV manufacturing platform with a capacity from 200 L to 2,000 L. Adeno-associated viruses (AAV) are non-enveloped, non-pathogenic viruses largely used as drug delivery vectors for biotherapeutics, like gene therapies and vaccines. Although the application of AAV is spreading rapidly, the industry is struggling to find cost-effective manufacturing strategies to reach clinical and commercial scales. The collaboration among Exothera, LogicBio, and Polyplus aims to focus on the scale-up of a transient transfection-based AAV serotype 8 (AAV8) manufactured in suspension cell culture. The consortium selected the Allegro™ stirred tank Single-Use Bioreactor (from Pall) as a suspension culture device due to its scalability and single-use features. The project aims to assess reproducibility and comparability between the different scales of suspension bioreactors, up to 2,000 L bioreactor scale. Exothera will provide state-of-the-art production space, process development expertise and access to the latest enabling technologies. LogicBio will support the initiative with its mAAVRx™ plasmid technology and its AAV expertise. Polyplus will provide transfection reagent expertise with FectoVIR®-AAV for a smooth scaled-up GMP-eligible process development. Exothera's team is proud to work with the experienced teams at biotech companies like LogicBio and Polyplus. The success of AAV-based therapeutics requires a change in the manufacturing paradigm and through this collaboration, we aim to enable a new approach to consistently scale AAV manufacturing." Hanna Lesch, Chief Technology Officer at Exothera: " We are excited to collaborate with Exothera, an emerging leader in the CDMO industry and with Polyplus, a long-time transfection partner, for implementing an AAV manufacturing process at 200L scale and above. We believe our proprietary mAAVRx™ plasmid technology could dramatically help to improve manufacturing yields and consequently reduce AAV manufacturing costs. We are hopeful that the work done under this collaboration will be an important step forward in making gene therapy products accessible for a greater number of patients.". Matthias Hebben, Global Vice President, Technology Development at LogicBio. We are delighted to scale up AAV Viral vector Manufacturing processes to larger bioreactor volumes with innovators in the industry like Exothera and LogicBio. At Polyplus we aim to improve gene-therapy viral vector manufacturing economics by increasing titers in the upstream processes using novel transfection reagents like FectoVIR®-AAV. The collaboration will use a combination of state-of-the-art manufacturing technologies, innovative plasmid technologies and scalable transfection reagents which will make gene-therapy viral vector therapies affordable". Roel Gordijn, Chief commercial Officer at Polyplus. Exothera specializes in the industrialization of vaccine and gene therapy processes. It has recently performed successful viral vector manufacturing scale-up studies in adherent and suspension cell systems helping its clients to reach the clinical trial scale. Additionally, the team is operating and continuously improving its own GMP manufacturing platform, exoREADY, for viral vector-based gene therapies and vaccine production. About Exothera SA Exothera is a viral vector CDMO (contract manufacturing and development organization) using standard and innovative bioproduction platforms to rapidly deliver affordable viral vector-based vaccines and cell and gene therapies. As a Univercells company, Exothera capitalizes on novel manufacturing technologies and best-in-class bioprocessing expertise to provide custom-made process optimization and GMP clinical and commercial production of viral vectors. Based on its extensive technology expertise, Exothera selects technologies to optimally answer customer needs for cost-effective and agile viral vector manufacturing and provides QC services and analytical development. About LogicBio® Therapeutics LogicBio® Therapeutics is a clinical-stage genetic medicine company pioneering genome editing and gene delivery platforms to address rare and serious diseases from infancy through adulthood. The company's genome editing platform, GeneRide®, is a new approach to precise gene insertion harnessing a cell's natural DNA repair process potentially leading to durable therapeutic protein expression levels. The company's gene delivery platform, sAAVy™, is an adeno-associated virus (AAV) capsid engineering platform designed to optimize gene delivery for treatments in a broad range of indications and tissues. The company's proprietary system, mAAVRx™, aims to overcome some of the current limitations of AAV manufacturing by optimizing the transfection process to improve yields and product quality. The company is based in Lexington, MA.

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MEDTECH

AMPEL BioSolutions' Precision Medicine Breakthrough Predicts Drug Options with RNA Analytics & Machine Learning

AMPEL BioSolutions | July 07, 2022

AMPEL BioSolutions announces a breakthrough in precision and personalized medicine that could modernize the way doctors treat patients across a wide variety of diseases including autoimmunity, infectious disease and cancer. Revealed at the Precision Medicine World Conference in Silicon Valley California, the first-in-class platform technology utilizes RNA analytics and machine learning to characterize an individual's gene expression and provide clinical decision support to physicians for treatment options for their patients. The technology, only a concept for the last few years, is being utilized to launch a portfolio of 10+ clinical tests over the next five years to provide decision support for diseases that affect more than 50 million Americans. AMPEL's innovative machine learning approach, which is now ready to be developed as a clinical decision support biomarker test, could greatly impact health care by allowing physicians to identify the cause of patient disease symptoms and select appropriate treatment more precisely. AMPEL's approach is sufficiently sensitive to detect early signs of disease and group patients by the severity of their condition. The application of AMPEL's technology is already assisting 15+ pharmaceutical companies in drug development and clinical trials. Patients with autoimmune and inflammatory diseases often suffer from unpredictable disease activity that impacts daily activities like work and family life. Since unpredictable symptoms often result in trips to the Emergency Room, the ability to predict worsening disease and systemic involvement with routine testing has important health care and health economics implications. AMPEL expects to bring it's first two products to market in the next few years, LuGENE® blood test for Lupus and DermaGENE® skin biopsy test for Psoriasis, Atopic Dermatitis, Scleroderma and Lupus. In addition, AMPEL's CovGENE® blood test that predicts how severe a disease course a COVID patient may experience and may be applicable to "long COVID" is ready for licensing/co-development with a company already offering COVID diagnostic testing. Paired with AMPEL's pipeline of tools to analyze very large and complex clinical datasets ("Big Data"), AMPEL's Genomic Platform technology with machine learning is a significant step towards implementing routine testing to monitor disease activity and provide decision support for treatment based on a patient's gene expression. This will transform the way doctors treat patients by using the information gathered by the lab test and analyzed by machine learning to diagnose, characterize the precise molecular abnormalities and treat diseases before damage begins, saving patients from pain and inconvenience of diseases that otherwise drastically affect their lives. Pharmaceutical companies test drugs in clinical trials and face the challenge of enrolling patients that have the best potential to respond to the treatment being tested. Enrolling the "wrong" patients can result in trial failure, often leading to cancellation of a drug's development towards FDA approval that may have benefit in a sub-group of the overall patient population. AMPEL's technology helps pharmaceutical companies proactively identify the patients most likely to respond to specific treatments, thereby helping improve outcomes in clinical trials and quality of life for patients in need. AMPEL's Pharma work was highlighted by Dr. Peter Lipsky at the Precision Medicine World Conference in a panel discussing the use of machine learning in clinical trial patient selection and outcome prediction and by Dr. Amrie Grammer at a Google-Reuters webinar focused on machine learning approaches to select the right patient for the right trial at the right time. "It is very gratifying to see a concept develop into a reality that can help patients. When we began some years ago we thought that analyzing gene expression data could subset patients effectively and allow the molecular profile of each patient to be used to help identify the best treatment for each individual. By applying novel machine learning approaches, we are now ready to launch our first application that we believe should be a major step toward providing patients with autoimmune diseases true precision medicine." Dr. Peter Lipsky, AMPEL Co-Founder, CEO and Chief Medical Officer Dr. Amrie Grammer, AMPEL Co-Founder, President and CSO: ""Our team has developed a genomic platform technology with machine learning that supports clinical precision medicine tests that predict drug options based on gene expression. AMPEL is changing the paradigm of treatment in autoimmune and inflammatory diseases. We are proud to be doing this work in Virginia and will continue to recruit talent and grow our business here." Many chronic diseases have unexpected flares that dramatically affect patient quality of life. Further, treatments for chronic disease have been developed based on a patient population as a group, so some individuals will respond differently or not at all to available treatments. For the past nine years, the scientists and clinicians at AMPEL have been working on ways to address this problem, by designing concepts to personalize treatments for an individual patient as opposed to a patient population. Peer reviewed publications confirm the practicality of AMPEL's concept, which are now in the commercialization phase. AMPEL's initial focus was lupus but the test can be used for many autoimmune or inflammatory diseases. AMPEL's blood and tissue biopsy tests are prognostic and staging biomarkers that will provide decision support for their physician with the most appropriate drugs for the patient at that moment in time. About AMPEL BioSolutions LLC AMPEL BioSolutions is a precision medicine company commercializing a development pipeline of CLIA-certified gene expression tests for blood or tissue samples that provide clinical decision support by determining disease status, identifying molecular pathway and predicting drug options. AMPEL's technology is a cloud-based platform that hosts proprietary RNA analytic tools and machine learning algorithms covered by 25+ filed/pending patents and 80+ peer-reviewed publications in high impact journals. Disease Areas for AMPEL's precision medicine test portfolio include Systemic Lupus Erythematosus, Psoriasis, Scleroderma, Atopic Dermatitis, Lupus Nephritis, Fibromyalgia, Cardiovascular, Sjogren's Syndrome, ASD, Wellness, Lung Cancer and SARS-Cov2. AMPEL's technology covers over 95% of all known genes and AMPEL's exclusive curated database of >15,000 individual gene expression profiles with rich clinical information fuels machine learning predictions based on evidence. AMPEL BioSolutions was elected to the Coalition for 21st Century Precision Medicine in early 2022.

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Spotlight

Single-use technology (SUT) products are widely accepted for the manufacturing of vaccines and biologics. The increase in adoption of single-use Thermo Scientific™ BioProcess Containers (BPCs) is a result of their demonstrated performance, and their cost- and timesaving benefits. The quality and purity of the plastics used to produce Thermo Scientific™ Single-Use Bioreactor (S.U.B.), Single-Use Mixer (S.U.M.), and Single-Use Fermentor (S.U.F.) BPCs and storage bags are crucial to the purity and efficacy of final biopharmaceutical drug products.

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