Q2 Solutions brings more than 20 years of experience in bioanalytical services, developing robust methods to support all stages of drug discovery and development. We have developed and validated assays for a range of applications, including ADME screening/ADME testing, discovery and development metabolite identification, drug metabolism and pharmacokinetics, immunogenicity testing, biomarker analysis and characterization, and biosimilars testing. Methodologies include LC/MS bioanalysis, LC/MS/MS analysis, hybrid LC/MS assays, and immunoassay and MS-based biomarker assays. Prior to validation, each assay undergoes a formal pre-qualification process in which Q2 Solutions scientists review preliminary data and assess modifications necessary to support validation.
The link below provides a list of validated bioanalytical methods developed by Q2 Solutions to support clinical trial applications, including COVID-19 trials. In addition to listed assays, Q2 Solutions develops customized methods to meet specific challenges.
Your clinical trial may involve samples from multiple sites to be tested by multiple laboratories. The data that flows from those tests may travel to multiple end users as well. Proper planning of...
In this episode, the second of a three-part series, Alex Watt, Global Head for Biotech Integrated Laboratory Solutions and Alan Wookey, Global Head of Companion Diagnostics discuss how to manage...
Assessing the pharmacokinetics of biologics presents several analytical challenges, from the use of critical reagents and assay sensitivity requirements to regulatory and throughput considerations....