On average, members of the Elion team have over 15 years of direct experience in the biopharmaceutical industry, largely focused on bringing clinical products to market as well as lifecycle management of commercial protein products. We have directly supported world-wide regulatory applications for registration of multiple biologics by authoring and reviewing CMC components of those applications, including elucidation of structure, drug substance and drug product impurities, reference standard qualification, specifications, stability, comparability, biosimilarity and integrated control strategy sections.
Furthermore, our team has extensive experience with product characterization requirements, including meeting regulatory expectations for biochemical, biophysical, particle, and degradation pathway characterization. Our team has supported over 100 comparability studies, 30 stability studies, and 20 reference standard qualifications. We have developed and implemented universal characterization methods, qualification approaches, and acceptance criteria, leading to significantly increased efficiency in the application of analytical methods.
We have a proven track record in gaining regulatory approval in multiple jurisdictions for reductions in Quality Control analytical testing by creating science-based justifications to eliminate redundant or non-value added tests and focusing testing on the most relevant product quality attributes. We have developed rapid analytical test methods, improved data analysis methods, and statistical biosimilarity strategy for demonstrating overall similarity of biosimilar products to innovator products. At Elion, we are committed to using appropriate technologies, sophisticated data analysis, and our prior experience to provide significant value to our clients.
Characterization of the higher order structure (HOS) of biological products has been growing in importance in recent years. Scientists in the biopharmaceutical industry, academic researchers, and regulators are all increasingly aware of the critical role that HOS plays
We look forward to partnering with you on your path to product commercialization.