Bioanalysis
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.
Up Close and Personal with Dr. Lynne Le Sauteur, PhD
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
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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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Rigorous Sample Handling Processes
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
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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. |
Complimentary Webinar — Critical Sample Handling Processes for Preclinical and Clinical Studies
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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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Get Up Close and Personal with Dr. Anahita Keyhani, PhD
Dr. Anahita Keyhani is Altasciences' Senior Director of Scientific Operations, Mass Spectrometry and Method Development.
Improve your Drug Development Success with Biomarkers
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Including biomarkers early on in the drug development process can make use of genomic and proteomic techniques, thereby increasing the probability that initial administration to humans will be safe, or help determine the relevance of animal findings in humans. In a clinical environment, such information can be used to exclude participants from trials, or monitor reactions to drugs in participants who may be at risk from a treatment. Join our experts at the 14th WRIB Virtual from June 15-29 to learn more about Altasciences' list of biomarkers and to understand how our integrated biomarker approach from preclinical to clinical can enhance the safety of new drugs, improve the assessment of promising drug candidates, as well as reduce the cost of developing drugs and bringing them to market. |