New digital filter approach aims to improve chemical measurements

eurekalert | May 02, 2019

Precise measurements are critical to the discovery, development and usage of medications. Major financial and scientific decisions within pharmaceutical companies are informed by the outcomes of chemical and biological analyses. Even slight measurement variations can add risk and uncertainty in these high-stakes decisions. A Purdue University professor and expert in measurement science has led a team to design a new filter aimed at helping drug developers and researchers create more exact measurements early in the drug development stage, which can ultimately help move a drug to clinical trials faster. Garth Simpson, a professor of analytical and physical chemistry in Purdue's College of Science, created the filter as part of his work with the Merck-Purdue Center for Measurement Science. The academic-industrial partnership, which started in 2017, is focused on developing technology to improve drug manufacturing and formulation to support the pharma industry in expediting drug discovery and delivery. According to the Food and Drug Administration, it can take up 10 to 15 years or longer to move a drug from discovery to the public.

Spotlight

he number of monoclonal antibody and recombinant protein product opportunities in the biopharmaceutical market is increasing. This is driving the need for experienced, sophisticated manufacturing partners that can support pre-clinical through commercial programs.

Spotlight

he number of monoclonal antibody and recombinant protein product opportunities in the biopharmaceutical market is increasing. This is driving the need for experienced, sophisticated manufacturing partners that can support pre-clinical through commercial programs.

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CELL AND GENE THERAPY

Astellas and Dyno Therapeutics Announce Research Collaboration to Develop Next-Generation AAV Gene Therapy Vectors for Skeletal and Cardiac Muscle

Astellas Pharma Inc. and Dyno Therapeutics, Inc. | December 02, 2021

Astellas Pharma Inc. and Dyno Therapeutics, Inc. announced an option and license agreement was signed on November 23 to develop next-generation adeno-associated virus vectors for gene therapy directed to skeletal and cardiac muscle using Dyno's CapsidMap™ platform. Dyno's CapsidMap platform represents a transformative approach applying in vivo experimental data and machine learning to create novel AAV capsids – the cell-targeting protein shells of viral vectors – designed to optimize tissue targeting and immune-evading properties, in addition to improving packaging capacity and manufacturability. Unlike traditional approaches, CapsidMap is uniquely well-suited to simultaneously optimize capsids for delivery across multiple organs, with the goal of enabling more effective whole-body treatment for many diseases. With the establishment of the Astellas Gene Therapies Center of Excellence following the 2020 acquisition of Audentes Therapeutics Inc., Astellas is a leader in genetic medicines, working alongside its world-renowned partners to build a portfolio of potentially life-changing gene therapies. This research collaboration combines Dyno's AI-powered AAV vector engineering capabilities with Astellas Gene Therapies global leadership in AAV-based pipeline assets. "Through our efforts in gene therapy and the Astellas Gene Therapies Center of Excellence, Astellas strives to identify, develop and deliver transformative gene-based therapies for patients with genetic diseases who currently have few or no effective treatment options. Our principal focus is on developing adeno-associated virus delivered therapies for the treatment of well-defined serious diseases. We are dedicated to delivering novel approaches and utilizing new technologies that can deliver transformational value for patients." Naoki Okamura, Chief Strategy Officer and Chief Financial Officer, Chief Business Officer at Astellas "We are so happy to be partnering with Astellas, a world leader in developing gene therapies. Dyno and Astellas each bring unique strengths to this collaboration, together enabling more rapid creation of new therapies for patients with great unmet need," said Dyno's CEO and co-founder Eric D. Kelsic, Ph.D. "This partnership demonstrates the flexibility of Dyno's platform to precisely design the delivery properties of gene therapy vectors towards multi-organ and disease-specific profiles, applying the scientific insights we are rapidly learning across all our partnered and internal vector engineering programs using CapsidMap." Under the terms of the agreement, Dyno will design novel AAV capsids with improved functional properties for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities, including manufacturing, of gene therapy product candidates using the novel capsids. Dyno will receive an $18 million upfront payment and be eligible to receive additional payments during the research phase of the collaboration as well as clinical and sales milestone payments and royalties for any resulting products. The aggregate potential value of future milestone and royalty payments to Dyno exceeds $235 million per product and over $1.6 billion in total value. About Astellas Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. About Astellas Gene Therapies Astellas integrated its wholly owned subsidiary, Audentes Therapeutics, Inc. as of April 1, 2021 and established "Astellas Gene Therapies" within the organization as an Astellas Center of Excellence to develop genetic medicines with the potential to deliver transformative value for patients. Based on an innovative scientific approach and industry leading internal manufacturing capability and expertise, we are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown and hope to also advance additional Astellas gene therapy programs toward clinical investigation. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. About Dyno Therapeutics Dyno Therapeutics is a pioneer in applying artificial intelligence and quantitative in vivo experiments to gene therapy. The company's proprietary CapsidMap™ platform rapidly discovers and systematically optimizes Adeno-Associated Virus capsid vectors that significantly outperform current approaches for in vivo gene delivery, thereby expanding the range of diseases treatable with gene therapies. Dyno was founded in 2018 by experienced biotech entrepreneurs and leading scientists in the fields of gene therapy and machine learning. The company is located in Cambridge, Massachusetts.

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GenScript Receives FDA Emergency Use Authorization for cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit

GenScript | November 10, 2020

GenScript USA Inc., the world's leading research reagent provider, announced today that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit. This is the first commercially available test to specifically detect neutralizing antibodies without the use of live virus. Neutralizing antibodies, a subset of antibodies that are specifically able to block the ability of the virus to enter a cell, are widely recognized biomarkers of immunity. The test measures the presence of neutralizing antibodies in any sample, from those from patients recovering from COVID-19 or those vaccinated against SARS-CoV-2. The conventional method for measuring neutralizing antibodies requires testing to be performed in a high safety-level facility (BSL3) staffed with specialized personnel. Typically, results from the live virus assay are available in several days and due to the unpredictable nature of the live virus and live cells reagents used, these tests are also difficult to standardize. Results from different facilities may vary, even if performed using the same protocol. In contrast, the cPass™ kit utilizes pure proteins that can be produced in a more reproducible way. The detection of the presence of neutralizing antibodies can also be performed in most standard research or clinical diagnostic laboratories with short turnaround time (~1hr), making it broadly available and much more consistent between different facilities. Furthermore, a comparison of the direct clinical performance between the conventional live virus and the cPass™ assay shows results from both tests are strongly correlated.

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RESEARCH

Cedilla Therapeutics Expands Leadership Team with Key Appointments Across R&D And Finance

Cedilla Therapeutics | November 17, 2021

Cedilla Therapeutics, a biotechnology company bringing a new dimension to precision oncology, announced appointments across its research and development (R&D) and finance teams, including Joshua Murtie, Ph.D., as Vice President of Biology and Chris Lindblom as Vice President of Finance. These hires are part of an ongoing initiative to expand Cedilla’s leadership and enable future growth as the company progresses its lead programs, conditional inhibitors of TEAD and CDK2, toward the clinic and continues to develop a broad portfolio of small molecule medicines that target key oncogenic drivers. “We are delighted to expand our team with these key hires, who share our passion and commitment to developing targeted medicines that conditionally modulate proteins in their functional state. We look forward to Joshua and Chris’ many contributions as we continue to explore the power of our novel approach to access historically undruggable cancer drivers, advance our lead conditional inhibitor programs targeting TEAD and CDK2 into clinical development, and ultimately build Cedilla into a fully integrated organization and leader in precision medicine.” Alexandra Glucksmann, Ph.D., President and Chief Executive Officer of Cedilla Therapeutics Joshua Murtie, Ph.D., has been appointed Vice President of Biology. Dr. Murtie brings over ten years of industry experience to Cedilla. He worked most recently as Senior Director at Servier Pharmaceuticals, where he oversaw cancer biology, in vivo pharmacology and early-stage program management at the company’s U.S. research site. Earlier, he spent nearly seven years at Agios Pharmaceuticals in roles of increasing responsibility, ultimately serving as Senior Director and Head of Cancer Biology, with responsibility for the strategic oversight of the company’s cancer biology portfolio from early target discovery to translational research. Prior to Agios Pharmaceuticals, Dr. Murtie worked as an investigator at Sanofi and Novartis. He holds a Ph.D. in molecular and cell biology from the Uniformed Services University of the Health Sciences and completed his research fellowship at Harvard Medical School. “I am thrilled to join Cedilla, particularly as we prepare to advance our lead programs, targeting TEAD and CDK2, into investigational new drug application-enabling studies next year,” said Dr. Murtie. “Both TEAD and CDK2 are well-known yet elusive cancer targets, which, if drugged successfully, could benefit the lives of patients living with a broad range of solid tumors. I am incredibly impressed by the collaborative and innovative culture at Cedilla and look forward to working closely with the team to translate our research efforts into precision therapies for patients in need.” Chris Lindblom has been appointed Vice President of Finance. Over the course of his 19 years in the biotechnology industry, Mr. Lindblom has crafted long-range financial plans for public and private companies and played a key role in helping companies raise capital through private equity rounds, venture debt deals and public offerings. Prior to joining Cedilla, Mr. Lindblom served as Vice President of Finance at IFM Therapeutics, Cogen Immune Medicine (through its merger with Torque Therapeutics to form Repertoire Immune Medicines) and Warp Drive Bio (through its acquisition by Revolution Medicines). Earlier, Mr. Lindblom held various senior finance roles at Millennium Pharmaceuticals, including through the commercial launch of VELCADE®, and at Infinity Pharmaceuticals. He also served as Vice President of Finance at OvaScience and Senior Vice President of Finance and Administration at BIND Therapeutics. Mr. Lindblom holds an MBA from Boston College and a B.S. in accounting from Syracuse University. He is also a CPA. “Since its founding, Cedilla has attracted a strong team, including leading scientists and advisors and a robust investor syndicate, to support its mission to bring a new dimension to precision oncology and deliver medicines that can offer profound benefits to patients,” said Mr. Lindblom. “I am honored to take on this role and eager to partner with my new colleagues as we continue building Cedilla for its next phase of growth.” About Cedilla Therapeutics Cedilla Therapeutics is bringing a new dimension to precision oncology. We have discovered new ways to selectively inhibit oncogenic drivers with small molecules that conditionally modulate proteins in their functional state. Our conditional inhibitors are unlocking critical and elusive cancer targets including TEAD and CDK2. We are a driven and patient-focused team.

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