CELL AND GENE THERAPY, INDUSTRY OUTLOOK
Businesswire | May 09, 2023
Life Biosciences a biotechnology company advancing innovative cellular rejuvenation technologies to reverse diseases of aging and injury and ultimately restore health for patients, and Forge Biologics (“Forge”), a genetic medicines manufacturing organization, today announced a manufacturing partnership to help advance Life Bio’s partial epigenetic reprogramming platform to address aging-related diseases, including its lead program targeting ophthalmic indications.
“Life Bio is an emerging leader in the development of novel therapies for aging-related diseases, and we are thrilled to serve as their cGMP manufacturing partner to help advance the manufacturing of AAV for their innovative cellular rejuvenation technology, which has the potential to benefit millions of aging patients worldwide,” said Timothy J. Miller, Ph.D., CEO, President, and Co-Founder of Forge.
Through this partnership, Forge will provide adeno-associated virus (AAV) process development, toxicology, cGMP manufacturing, and analytical services to Life Bio. The company will utilize Forge’s platform processes including its proprietary HEK293 suspension Ignition Cells™ and pEMBR™ adenovirus helper plasmid. All development and AAV manufacturing activities will occur at the Hearth, Forge’s 200,000 square foot gene therapy facility in Columbus, Ohio.
“We are delighted to be working with the Forge team, whose expertise in gene therapy manufacturing is unmatched,” said Jerry McLaughlin, Chief Executive Officer of Life Biosciences. “We believe we’re on the cusp of revolutionizing medicine with our cellular rejuvenation capabilities across a range of aging-related diseases, including ophthalmic disorders that involve retinal ganglion cell dysfunction. We are confident our partnership with Forge will have a tremendous impact on our ability to enhance the speed and quality with which we can manufacture our therapeutic candidates as we progress toward the first human clinical trials and continue to develop treatments to reverse diseases of aging by restoring cells to a more youthful state.”
About Forge Biologics
Forge Biologics is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company. Forge’s mission is to enable access to life-changing gene therapies and help bring them from idea to reality. Forge’s 200,000 square foot facility utilizes 20 cGMP suites in Columbus, Ohio, the Hearth, to serve as its headquarters. The Hearth is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services. Offerings include process and analytical development, plasmid DNA manufacturing, viral vector manufacturing, final fill, as well as regulatory consulting support to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing. By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most.
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MEDTECH, INDUSTRIAL IMPACT
Globenewswire | April 13, 2023
Centogene N.V. the essential life science partner for data-driven answers in rare and neurodegenerative diseases, today announced the launch of NEW CentoGenome®, an enhanced Next Generation Sequencing (NGS)-based assay. Healthcare professionals can leverage NEW CentoGenome to provide more comprehensive diagnostic information, which could accelerate access to potential treatment options.
Serving as a first-line test, NEW CentoGenome is the most comprehensive commercially available Whole Genome Sequencing (WGS) test on the market for both rare and neurodegenerative disorders – covering almost all disease-causing variants, including the most relevant repeat expansions associated with neurological diseases, in a single assay. NEW CentoGenome also detects Copy Number Variations (CNVs) associated with Spinal Muscular Atrophy (SMA), as well as complex disease-causing variants associated with Gaucher Disease (GD) and susceptibility to GBA1-related Parkinson's Disease (PD), with the highest levels of sensitivity.
The newly designed WGS assay leverages a Polymerase Chain Reaction (PCR)-free approach. This significantly diminishes the typical bias induced by PCR and provides higher quality sequencing data across the typically challenging regions of the genome by enabling more uniform coverage and superior performance in variant detection.
“As a pioneer of genetic diagnostics, we are committed to enabling access to high-quality diagnostics and ensuring that cutting-edge data analyses are available to support better patient health outcomes,” said Prof. Peter Bauer, Chief Medical and Genomic Officer at CENTOGENE. “Building on this expertise, CENTOGENE’s enhanced whole genome sequencing is the leading solution on the market, reflecting the latest advanced technologies and unique insights that can’t be found anywhere else to provide maximized disease coverage. Ultimately, this will provide physicians with an unparalleled level of certainty when diagnosing, prognosing, and treating patients.”
CENTOGENE’s NEW CentoGenome - Superior Technology With Market-Leading Clinical Coverage in a Single Test
CENTOGENE’s enhanced WGS solution consists of three seamlessly integrated key features
Advanced Technology for Greater Insights
Implementing PCR-free technology to significantly reduce bias and provide high-quality sequencing information for difficult-to-sequence genetic regions – enabling greater insights into coding, regulatory, and intronic regions
Superior Performance for Enhanced Disease Coverage
Delivering superior performance in variant detection thanks to CENTOGENE’s automated CE-IVD bioinformatics pipeline and medical expert-based analysis of the CENTOGENE Biodatabank, which consists of approximately 700,000 patients representing over 120 highly diverse countries
Integrated Variant Reclassification and Confirmatory Testing for a Life-Long Commitment to Patients
Demonstrating CENTOGENE’s unique commitment to improving the lives of patients with rare and neurodegenerative diseases, NEW CentoGenome is paired with life-long diagnostic support and a free-of-charge and proactive diagnosis confirmation and reclassification program
About CENTOGENE
CENTOGENE’s mission is to provide data-driven, life-changing answers to patients, physicians, and pharma companies for rare and neurodegenerative diseases. We integrate multiomic technologies with the CENTOGENE Biodatabank – providing dimensional analysis to guide the next generation of precision medicine. Our unique approach enables rapid and reliable diagnosis for patients, supports a more precise physician understanding of disease states, and accelerates and de-risks targeted pharma drug discovery, development, and commercialization.
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CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Bio-Techne Corporation | March 20, 2023
Bio-Techne Corporation announced it has completed its participation in the Cell and Gene Therapy Catapult Process Analytical Technology (Catapult PAT) consortium, a multi-year collaboration involving 24 partner companies, technology providers, therapy developers, and charities. The Catapult PAT consortium is the first initiative of this scale and functional expertise with member companies and organizations collaborating to develop cell and gene therapy-specific process analytical technologies.
The PAT initiative began in January 2021 with a series of experiments designed to monitor process parameters of an exemplar 8-day T-cell expansion bioprocess using primary T-cells. Data were gathered from five independent analyses to generate an extensive, world-first dataset. An analysis of multiple cytokine targets was conducted using high-plex Luminex® immunoassays and the precision multiplexing Ella™ platform from Bio-Techne. The automated workflow of the Ella platform proved to be particularly amenable to the efficiency, accuracy, and throughput demands inherent in a bioprocess manufacturing environment. With its robust performance in this project, the Cell and Gene Therapy Catapult plans to incorporate Ella™ into an existing CGT Catapult facility to further support scientists in the UK.
"As a leader in the forefront of innovative tools to measure cytokines, we are honored to be a part of the Catapult PAT initiative to help advance cell and gene therapy development," said Will Geist, President of Bio-Techne's Protein Sciences Segment. "Bio-Techne remains excited about the potential of these advanced therapies to improve patient outcomes and treat a wide range of diseases that currently have very poor or ineffective treatments."
Established by Innovate UK, the Cell and Gene Therapy Catapult fosters collaborations between academia, industry, and healthcare providers to develop new technology and drive innovation. Catapult experts cover all aspects of advanced therapies, from research and development to clinical adoption and every step in between.
About Bio-Techne
Bio-Techne Corporation is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne products assist scientific investigations into biological processes and the nature and progress of specific diseases. They aid in drug discovery efforts and provide the means for accurate clinical tests and diagnoses. With thousands of products in its portfolio, Bio-Techne generated approximately $1.1 billion in net sales in fiscal 2022 and has approximately 3,000employees worldwide.
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