Bioanalysis

  • Bioanalysis
  • Denver, Colorado, skyline.

    CYTO 2025, the 38th annual Congress of the International Society for the Advancement of Cytometry, is the premier, inclusive, and international conference on the many facets of cytometry science and engineering.

    We were thrilled to represent Altasciences at this year’s American Society for Mass Spectrometry (ASMS) conference in Baltimore. With 6,000 scientists, students, and industry professionals from around the globe in attendance, it was an excellent opportunity to learn about the latest developments in mass spectrometry and share insights with other passionate scientists.

    New immunomodulatory drugs have the potential to cause serious immune-related adverse events, including cytokine release syndrome (CRS). CRS is a systemic inflammatory response characterized by the release of

    In Issue 44 of The Altascientist, we review strategies, including those implemented at Altasciences, for developing, qualifying, and implementing cytokine release assays (CRAs) to assess the safety of test articles in vitro to complement in vivo preclinical safety assessments, in addition to: 

    • the importance of nonclinical cytokine release evaluation
    • customized approaches to CRA use in drug development
    • top five aspects to consider before running a CRA
    • Altasciences’ case results
    • how Altasciences can help 

     

     

    Drugs that are likely to require CRAs  as part of derisking their development include, but are not limited to:

    By Martin Rougée, Optimization Scientist, Bioanalytical Operations

    Automation offers several advantages to any industry. For a contract research organization (CRO), it can play an integral role in increasing the quality and speed of drug development while reducing costs, repetitive manual tasks, and human error. For biotechnology and pharmaceutical companies, automation can decrease their drug-to-market development time and remain financially competitive in an evolving market.

    The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.

    Altasciences’ Commitment to Supporting Pharma and Biotech With Comprehensive Bioanalytical Services

    Greater Montréal, Québec, 11/13, 2024Altasciences, a trusted drug development research partner  for over 30 years, continues its commitment to providing world-class bioanalytical services. This core business supports both preclinical and clinical studies conducted at Altasciences’ facilities, while also offering an extensive standalone solution to meet the diverse needs of clients. By delivering high-quality, flexible bioanalytical services, Altasciences remains dedicated to advancing drug development and empowering clients across every phase of research.

    For three decades now, Altasciences has taken pride in evolving their solutions to meet the needs of pharmaceutical and biotechnology companies of all sizes, including the expansion of their labs in Seattle, WA, Columbia, MO, and Laval, Quebec. Their three state-of-the-art bioanalytical laboratories feature mirrored operations and uniform protocols to maintain consistency and quality across client projects, ensuring reliable, high-quality data regardless of location. This high level of harmonization enables the seamless transfer and sharing of methods across its multiple laboratory sites, allowing the analysis of hundreds of thousands of samples efficiently.

    “Our extensive bioanalytical offerings are designed to support both standalone projects and Altasciences' integrated drug development solutions. Whether for preclinical or clinical studies, we provide tailored solutions to meet specific research needs. At Altasciences, we’re committed to facilitating every phase of the scientific journey with precision and care,” said Dr. Lynne Le Sauteur, Vice President of Laboratory Sciences at Altasciences. 

    Altasciences’ bioanalytical services are built around a comprehensive suite of capabilities tailored for both small and large molecules. Core offerings include drug quantification, metabolite and biomarker analysis, and immunogenicity testing, to support and advance a molecule from discovery to market. 

    Altasciences’ bioanalytical approach focuses on three core pillars: understanding and anticipating client needs as scientists, creating innovative solutions, and fostering collaboration through transparent communication. This client-centered approach has helped Altasciences build lasting partnerships, assisting clients in meeting complex regulatory standards while maintaining scientific rigor.

    To promote Altasciences’ bioanalytical services from discovery to Phase IV, they recently launched their Unveiling the Invisible video campaign to showcase how their bioanalytical solutions provide critical insights that unveil the invisible and drive the creation of innovative therapies.

    View the fascinating video series here.

    About Altasciences

    Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 30 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster. To learn more about Altasciences, visit Altasciences.com.

    Julie-Ann Cabana
    Altasciences
    jcabana@altasciences.com  
     

    Current and future development of glucagon-like peptide-1 receptor agonists (GLP-1 RAs), or simply GLP-1s, involves complexities not only in formulation but in all areas of early-phase drug development. Developing and refining preclinical models for early efficacy signals, developing and validating the bioanalytical assays necessary for quantitation, and designing the clinical studies that deliver the most robust data in this innovative therapeutic area are all key elements of a drug development program.

    In Issue 42 of The Altascientist, we review the requirements for successful GLP-1 drug development, including:

    • preclinical approaches
    • early-phase clinical study design
    • bioanalytical techniques
    • manufacturing

    Two case studies are also included. 

     

     

    There’s a lot of life science content out there, so for your convenience, we’ve curated a selection of expert insights, tips, case studies, and scientific and regulatory information. Catch up on what you might have missed below!

    Development and Validation of LC-MS/MS Assay Methods to Determine Ubrogepant and Atogepant in Human Breast Milk

    Subscribe to Bioanalysis