Bioanalysis

  • Bioanalysis
  • Expert Support for Your IND/CTA Requirements

    Partnering with Altasciences for your IND/CTA needs will ensure that your application to regulatory agencies moves forward as smoothly and efficiently as possible. To reach your milestones on time, we recommend setting up a meeting to consult with us at least six months before your required submission date.

    Contact our experts today.

    Altasciences can help you compile the key information necessary to approve your application request, including:

    • Animal pharmacology and toxicology studies to assess safety
    • Manufacturing processes to ensure consistent batches of the study drug
    • Clinical protocols and investigator information to assess tolerance and risk

    For a more detailed discussion of the regulatory planning process, consult our Preclinical Assessment Planning Guide.

    Altasciences’ Proactive Drug Development platform transforms the traditional outsourcing paradigm by providing you with expertly designed, customized roadmaps that seamlessly bring you from lead candidate selection to clinical proof of concept, and beyond.

    You may also be interested in the following:

    Using Anti-Drug-Antibody Screening Assay to Resolve Selectivity Issues in Toxicokinetic Ligand-Binding Assay

    Mitigation of On-Column Conversion of Ivabradine to Desmethylivabradine Metal Chelation With Citric Acid Modifier

    Dual Purpose of a Cell-Based Assay for an Agonist of the GLP-2 Receptor

    Development of an Oligonucleotide Drug Immunogenicity Assay: A Case for the Characterization of the Immune Response

    Transitioning Novel Scientific Workflows to Routine Bioanalysis

     

    Join Dr. Anahita Keyhani for a discussion on proactive, effective, and efficient bioanalytical project management, and the positive impact it can have on your drug development program.
     
    Topics covered include:

    • The framework for successful bioanalytical support at various phases and for different types of studies
    • Bioanalytical critical control points (operational, logistical, technical, and scientific) to proactively manage for successful project progression
    • Bioanalytical communication flow and key stakeholders for different types of studies

    Watch the webinar

    You may also be interested in the following:

     
    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

    Antisense Oligonucleotide Quantitation ― Accurate, Robust and Sensitive.

     

    Regulated bioanalytical development for the analysis of antisense oligonucleotides (ASOs) is showing promise in therapeutic applications for a number of diseases.  

    From preclinical to clinical, Altasciences has significant expertise in supporting robust and sensitive bioanalytical assays that minimize interference, for accurate quantification of ASOs in complex biological tissues.

    In the last couple of years, our bioanalytical scientific experts have developed close to 100 assays of various matrices, supported close to 100 preclinical and clinical studies at various stages, and analyzed over 15,000 samples in oligonucleotide quantitation.

    Speak with an expert today to ensure you are provided with the best bioanalytical techniques for your ASO drug development program.

    Speak with an expert today

    You may also be interested in the following:

    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

    Flow Cytometry Solutions to Support Your Preclinical and Clinical Studies

     

    Altasciences’ offers scalable flow cytometry solutions, and leverages extensive knowledge to help ensure a smooth transition from preclinical to clinical studies. We provide you with:

    • Dedicated flow cytometry scientists available to you early in the process to help determine the most appropriate strategy for non-GLP, GLP, and GCP testing
    • Extensive knowledge with exploratory and GLP studies from panel development to validation
    • Design and development of receptor occupancy (RO) assays
    • Strategically located laboratories in both the U.S. and Canada.
    • State-of-the-art instrumentation
    • Rapid turnaround between sample collection and analysis

    Altasciences has the same instrumentation in its U.S. preclinical site and Canadian site, which allows assay transfer for easy transition from preclinical to clinical studies.

    Download flow cytometry fact sheet

    Speak to a flow scientist for guidance on your assay development or validation strategy.

    You may also be interested in the following:

    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

    The Power of Microsampling in Preclinical Research

     

    As an alternative to traditional venipuncture, blood microsampling represents a less invasive and simplified collection technique, resulting in numerous benefits for preclinical and clinical studies alike.

    Microsampling in safety testing supports Altasciences’ commitment to the 3Rs: replace, reduce, and refine experimental animal use. It also provides other advantages, such as:

    • Accelerated animal recovery due to rapid blood collection
    • Direct correlation of study findings with PD and toxicological effects given the use of main study animals 
    • Less variability in PK profiles when derived from individual animals versus composite profiling  
    • Collection of additional PK/TK timepoints
    • Biomarkers and metabolites detection that aids interpretation of toxicological effect 
    • Reduced animal numbers saves on costs and time

    Speak with one of our microsampling experts today.

    You may also be interested in the following:

    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

    Expertise to Support the Approval of your 505(b)(2) or Hybrid Drug Submissions

     

    A generic molecule with a different route of administration, format, strength, or indication from the original reference product requires re-approval for market authorization, partly based on data from the original medicine, and partly on data from new clinical trials on the modified version.

    Consult The Altascientist for a review of the requirements for such approval, including a case study outlining three key studies we conducted for a 505(b)(2):

    three key studies we conducted for a 505(b)(2)

    Altasciences ensures a seamless process for your 505(b)(2) or Hybrid medicine submissions, with integrated manufacturing, bioanalysis and comprehensive research support services that can expedite your clinical trials.

    Speak with our experts.

    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

    You may also be interested in the following:

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