Overcoming challenges in preclinical bioanalysis: sponsors, CROs and technology working together
Within Contract Research Organizations (CROs) optimal assay selection and robust data delivery to meet tight timelines is of primary focus, yet bioanalysis for preclinical studies can present unique challenges relating to sample volume, novel therapeutic, or low abundance biomarker analytes. New approaches that shorten assay times, that also meet analyte challenges, are essential for swifter method development and validation, which accelerates workflows.
Charles River Laboratories (MA, USA) will be presenting case studies highlighting how time savings through automation and miniaturization were realized utilizing an automated microfluidic platform, which proved to be an effective approach for detection of analytes in small sample volumes, such as in preclinical PK studies.
What will you learn?
- How tight timelines and novel assay requirements can be addressed in an automated assay platform
- Efficient assay development for a low abundance human biomarker in limited sample volumes
- Development of a robust preclinical AAV immunogenicity assay in a microfluidic format
- Addressing the challenges of blood microsampling and robust PK profiles
Who may this interest?
- Outsourcing Managers at Biotech/Pharma
- Bioanalytical Scientists within Biopharmaceuticals (both Biotech/pharma and CRO)
- Project/Product Managers
- Group Leaders at Biotech/Pharma
- CRO Business Development Managers
Speakers
Kenneth Munroe
Principal Scientist I
Charles River Laboratories (MA, USA)
Ken has 38 years of experience, 29 years in research and 9 years at a Contract Research Organization. His experience is in vaccine development, infectious disease, immune modulation, oncology, rare disease and AAV gene therapy. After a long departure from contract research work, Ken has returned, working for Charles River Laboratories in the immunoanalytical assay group helping to connect sponsors with an appropriate method to address their needs.
Aruni Karunanayake
Scientist II
Charles River Laboratories (MA, USA)
Aruni is an assay development scientist and has 10+ years’ experience in research and development particularly in protein and nucleic acid analysis. Her experience is in RNA-based biosensor development for intracellular imaging, fluorescence/luminescence based nucleic acid analysis, immunoassay development and other protein-based biochemical/MS analysis. She has demonstrated ability to implement new techniques, independent experiment design, develop, optimize and quality control to support in vitro assay development. She has 14 publications to her name. She is now supporting the Charles River immunoanalytical team at the Worcester site to address sponsor needs and support their appropriate method need for oncology related in vitro studies.
This webinar was recorded on the 28th of June 2023.
In association with
