In this webinar, Ke Wang, Group Leader, Analytical Services of CMC Services at Frontage, introduces and discusses the application of ICP-OES and ICP-MS, similarities and differences, elemental impurities, extractable/leachable studies for inorganic extractables and leachables, and reverse engineering for generic drug development.
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In this case study, Frontage successfully completes the method development and validation under the Sponsor's pressing timelines, while providing high quality, and reproducible data with an ISR passing rate of over 90%.
In this eBook, we explore the various ways LC-MS is utilized for the bioanalysis of ADCs and the strategies used for ADCs in biotherapeutics and clinical development.
The microbiome continuously shapes its environment through a complex set of interactions, and the microbial flora within and outside the human body has an essential relationship to an organism’s health status. For instance, dysbiosis in the gut microflora is an established contributor to the development of pathological conditions such as chronic inflammatory bowel diseases, type 2 diabetes, and colorectal cancer. In the drug discovery industry, scientists must be proactive in detecting changes in the intestinal microbiome in response to novel therapeutics. Changes to the microbiome associated with probiotic and prebiotic administration must be carefully monitored. Characterizing changes to the gut microbiome whether by metabolic, enzymatic, biomarker, or genomic approaches is fraught with difficulty and has a high assay development and validation cost. Therefore, many companies have looked to partner with research organizations that have success with innovative microbiome analysis tools.
In this webinar, our distinguished speakers, Dr. David Kwok and Dr. David Willoughby discuss current biomarker identification and metabolic evaluation techniques of the human gut microbiome, as well as metagenomic sequencing modalities utilized to streamline results for expedited interpretation and analysis.