Bioanalysis

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    • From AAV to Biomarkers—Your 2025 Roadmap


    Support for Your Early-Phase Gene Therapy Program

    At Altasciences, we are committed to advancing gene therapies with precision and efficiency. In addition to hundreds of pre-screened AAV nonhuman primates (NHPs) available for gene therapy programs and decades of bioanalytical, nonclinical, and clinical expertise―we’ve compiled a comprehensive list of resources below:

    Key Considerations for Nonclinical AAV Gene Therapy Development

    A Comprehensive Guide to Gene Therapy and Improving AAV Efficiency

    Learn more about our track record, expertise in navigating regulatory requirements, and how we ensure the safety and efficacy of AAV-based therapies (three case studies included).


    Screening for Pre-Existing Antibodies to Adenovirus for Nonclinical Gene Tehrapy Programs

    In-House AAV Pre-Screening

    Detailed information on our in-house AAV pre-screening methods for removing nonhuman primates from toxicology studies if they have antibodies against AAV8 serotypes. It covers two main assays: total antibody screening (TAb) and neutralizing antibody screening (NAb).


    Nonclinical Studies in Cell and Gene Therapy

    Expert Insights on Cell and Gene Therapy Development

    This scientific journal reviews considerations for nonclinical cell and gene therapy development, including expert approaches to mitigate complex challenges, improve study efficiency, and maximize translational opportunities to first-in-human trials.


    Translational Biomarker Assays by Indication

    Altasciences’ Biomarkers by Indication

    Our expertise in biomarker analysis supports critical go/no-go decision making by providing insight into a drug’s efficacy, safety, and mechanism of action. Assessed early in the drug development process, biomarker assays can validate targets and identify potential toxicity.


    Ready to get your gene therapy development program started? Speak with one of our experts.


    Hot off the Press! - November 2024


    Altasciences Supports Metsera in Their Early Stage Clinical Trials for Obesity

    Altasciences is proud to have supported Metsera, Inc., a clinical stage biopharmaceutical company, with nonclinical and early-stage clinical trials. This support includes a recent Phase I/II trial of MET-097i: an ultra-long-acting injectable amylin analog and fully biased GLP-1 receptor agonist.

    In a trial conducted at our clinic, Metsera reported positive topline results. This study enabled Metsera to initiate a randomized 16-week Phase II trial of MET-097i, which could offer potential new treatment options for those affected by obesity. We also further supported Metsera with our proactive drug development solution, providing nonclinical, bioanalysis, CRO, and program management services for several other therapeutic candidates.

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

    A trusted drug development research partner for over 30 years, Altasciences remains committed to providing world-class bioanalytical services in support of the preclinical and clinical studies conducted at our cutting-edge facilities, as well as extensive standalone solutions to meet your diverse needs.

    Our flexible bioanalytical services from discovery to Phase IV empower clients across every phase of research.

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    Let's Promote Your Project!

    Interested in a custom press release, written by our experts, to feature the great research we do together? Email us to get started!

    You may also be interested in:


    [On-Demand Webinar] The Future of GLP-1 Drugs


    As GLP-1 drugs reshape the market, understanding their potential risks, applications, and economic effects is crucial for professionals in the pharmaceutical and healthcare industries.

    Join Altasciences’ webinar to discover future trends and potential breakthroughs.

    The Golden Era of GLP-1 Drugs

    Speak with one of our experts to discuss your drug development program.

    You may also be interested in these resources


    Altasciences’ Commitment to Bioanalytical Excellence


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

    We have been your trusted drug development research partner for over 30 years. We are committed to providing world-class bioanalytical services in support of the preclinical and clinical studies conducted at our cutting-edge facilities, as well as extensive standalone solutions to meet your diverse needs. Our flexible bioanalytical services from discovery to Phase IV empower our clients across every phase of research.

    We recently launched the Unveiling the Invisible video campaign to showcase how our bioanalytical solutions provide critical insights that unveil the invisible and drive the creation of your innovative therapies.

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    RELATED RESOURCES

    Our bioanalytical team excels in comprehensive bioanalytical services, including assay and method development, molecular biology, mass spectrometry, ligand binding assays, immunogenicity testing, biomarker analysis, flow cytometry services, and more, to support your journey from discovery through Phase IV.

    Below are some resources that highlight our extensive knowledge, and wealth of bioanalytical experience.


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

    Greater Montréal, Québec, 11/13, 2024 — Altasciences, 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  
     

    Discover the Dynamic Landscape of GLP-1 Drug Development


    In this issue of The Altascientist, we explore the current and future development of GLP-1 receptor agonists (GLP-1 RAs), and the complexities involved in the early phases.

    Topics covered include preclinical models, bioanalytical assays, clinical study design, manufacturing, and the expanding applications of GLP-1 drugs in treating various health conditions. Exclusive case studies are also presented.

    Managing the Complexities of Glucagon-like Peptide-1 Receptor Agonist Drug Development

    Questions about your drug development program? Speak with one of our experts.

    Related resources that may interest you:

    Sensitive ASO Quantitation for Decentralized Trials


    In this poster presentation, our scientific team demonstrates the promising future of blood microsampling in decentralized clinical trials to support the development of antisense therapeutic drugs.

    Find out how they achieved precision, accuracy, and linearity within acceptance criteria with our sensitive and selective bioanalytical method for determining ASOs. Covering an analytical range of 0.50 – 500 ng/ml, they used dried blood micro-samples collected via the Capitainer® qDBS (10 µL), and analyzed them using hybridization LC-MS/MS.

    You may also be interested in the following:


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

    Implementation of a Semi-Automated Bead Extraction Procedure During Analyte Purification for High Throughput Immunogenicity Assays

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