Bioanalysis

  • Bioanalysis
  • Over 20 Years of Bioanalytical Expertise

    From discovery to preclinical to Phase IV, our team of over 200 highly skilled bioanalytical experts are ready to help you with your bioanalytical needs. 

    We deliver world-leading science, proven data integrity, regulatory expertise, and use state-of-the-art instrumentation to support both small and large molecule bioanalytical programs, including: 

    • Small and large molecule LC-MS/MS
    • Microsampling
    • Ligand binding assays
    • Cell-based assays
    • Biomarker quantitation
    • Immunogenicity assessments
    • Kit preparation

    Find out more about how Altasciences can help you with your bioanalytical needs.

    Contact our experts today.

    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether 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.

    You may also be interested in the following: 

    Overcoming Bioanalytical Challenges with ADA Assays

    In recent years, there has been an increase in approved monoclonal antibodies for the treatment of a variety of diseases. The complex nature of these larger molecules generates unwanted immunogenicity that targets the therapeutic drug, impacting its safety and efficacy profile. At Altasciences, our technology and bioanalytical methods are constantly evolving to achieve highly sensitive and robust ADA assays. Our scientific experts understand the importance of putting into context the clinical relevance of the study to ensure the success of your drug product. 

    In this issue of The Altascientist, see how we overcome the challenges faced when evaluating ADA assays.

    Contact our experts to learn more about our large molecule expertise.

    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.

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    Dr.

    Determination of Normal: Flow Cytometry Analysis of Major Immune Cell Populations in Peripheral Blood of Naïve Cynomolgus Monkeys

    Assessment of Receptor Occupancy via Flow Cytometry: Benefits and Pitfalls of Two Common Approaches

    Complimentary Webinar – Latest Trends in Mass Spectrometry Applications 

    Passive immunotherapy refers to the transfer of antibodies to an unprotected individual for the treatment or prevention of disease. Monoclonal antibodies (mAbs) offer several advantages as passive immunotherapeutic agents since they can be manufactured at large scale with inherently high specificity and consistency.

    In this complimentary presentation, we summarize how we developed a hybrid LC-MRM workflow for the quantitation of mAbs used as passive immunotherapeutic agents of viral infections. The workflow is generic and does not rely on highly specific critical reagents. More importantly, it offers the potential for multiplexing should a combination of different antiviral mAbs be dosed simultaneously.

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    Regulatory Guidance

    Ensuring that current and relevant FDA and EMA guidances are applied to the handling of bioanalytical samples during clinical tria

    Altasciences Develops a Quantitative Serological Assay for the Detection of SARS-CoV-2 IgG Antibodies

    Altasciences in partnership with a number of not-for-profit organizations, is developing a quantitative serological assay for the detection of SARS-CoV-2 IgG antibodies. Using several different antigens to enable solutions, our partnerships will alleviate the supply and quality of reagents in order to support vaccine development.

    We have the experience and know-how to support your preclinical and clinical vaccine development programs.

    Contact us today

     

    Complimentary Webinar — Critical Sample Handling Processes for Preclinical and Clinical Studies

    Sample management at the test facility or clinical site, including sample collection an processing, is a critical aspect of regulated bioanalysis. This is reinforced in the FDA's final industry guidance on Bioanalytical Method Validation (BMV). For meaningful data, every effort should be made to ensure that the analytes' concentration is maintained, from sample collection to completion of bioanalysis.

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    Dr. Anahita Keyhani is Altasciences' Senior Director of Scientific Operations, Mass Spectrometry and Method Development.

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