Webinar Description:
The R&D department at Elion Labs (a division of KBI Biopharma) is studying the impact of manufacturing and formulation processes on protein structure. IR and CD spectroscopies are common techniques for this application. They can be used to assess and compare the impact of process changes on protein structure, structural comparisons of drugs made by different manufacturers (e.g. biosimilars), changes in structure that can occur in stored drug formulations, and optimizing protein formulations against structural impurities.

This webinar assesses the detectability of misfolded species by Microfluidic Modulation Spectroscopy (MMS), FTIR and CD spectroscopies using a new IR platform for the analysis of secondary structure from RedShiftBio. An IgG1 drug product, which is predominantly β-sheet, is used to assess misfold detection limits by quantitatively spiking in an α-helical structural impurity. The relative abilities of common spectral data comparison and deconvolution methods to detect misfolds will be discussed.

The AQS3pro, is a new protein characterization platform that delivers automated, high sensitivity spectroscopic analysis, allowing users to ‘see change™’ in the secondary structure of proteins over the concentration range of 0.1 to 200 mg/mL. It enables the A​ggregation, Q​uantification, Stability, S​tructure and S​imilarity measurements that underpin drug safety and efficacy. Its ability to provide multiple attribute data reduces or eliminates the need for performing separate measurements across different tools. Combined with its advanced automated multi-sample capability, the AQS3pro substantially streamlines the analytical workflow associated with the commercialization of biotherapeutics.

Learning Objectives

• How Microfluidic Modulation Spectroscopy (MMS) can be used to study protein secondary structure
• Introduction to the AQS3TMpro MMS system from RedShiftBio

Speakers:

Brent Kendrick
Vice President Research and Development
Elion Labs, a division of KBI Biopharma

Brent Kendrick received his B.S in Aerospace Engineering and his Ph.D. in Pharmaceutical Sciences from the University of Colorado. Prior to graduate school, Brent was a Surface Warfare Officer in the United States Navy. After joining Amgen in 1997, Brent served as Formulation Team Lead in Pharmaceutics for 2 products: Infergen and a novel thrombolytic enzyme, where he developed a patented lyophilized formulation. He then managed a clinical analytical laboratory team in Quality Control and served as Product Quality Lead for PEG-sTNFr1. In 2002, he joined Process Development and held roles as Analytical Sciences Team Leader for multiple late stage clinical products and Drug Substance Process Team Leader for Nplate from Phase III through Commercial Launch. He led his group at Amgen through multiple successful commercial product approvals (Nplate, Prolia/XGeva, Blincyto and T-Vec), technology transfers, validation campaigns and biosimilarity/comparability studies, as well as leading the creation of cross-functional guidelines on comparability, method development and validation strategy. He was Director of Amgen’s Attribute Sciences for Late Stage Clinical and Commercial Products, leading a team of over 100 staff and multiple sites worldwide. He has been an adjoint and adjunct faculty member at the University of Colorado for over 15 years, teaching a lecture on light scattering biophysics every other year. He taught a semester-long 3 credit hour course on Heat Transfer in the CU Chemical Engineering Department, co-founded Elion, LLC, a contract analytical and formulations laboratory and consulting company for biotechnology product development, and most recently serves as Vice President, Research and Development at Elion Labs, A Division of KBI Biopharma.

Eugene Ma
Co-Founder and Chief Technology Officer
RedShiftBio

Eugene, CTO of RedShiftBio, is responsible for technology innovation and technical support across the full range of activities at RedShiftBio. Eugene has a BSEE from Yale University, and a MA and PhD in electrical engineering from Princeton University. He has also studied business at the Wharton School, University of Pennsylvania.