Raman spectroscopy offers a unique opportunity to do so by elucidating secondary structure and tertiary markers simultaneously in highly concentrated protein samples with several known pharmaceutical excipients.
To better characterize a protein’s stability profile, it is essential to perform experiments at the formulated conditions of that protein: the desired protein concentration of product with all associated excipients. Furthermore, we quantified the size and numbers of subvisible particles using nanoparticle tracking analysis (NTA) ( 1). We also evaluated certain concentration-dependent parameters: viscosity (using a Viscosizer 200 instrument from Malvern Instruments), interaction parameter ( k D) using DLS, and osmotic second virial coefficient (B 22) using static light scattering (SLS). We developed and optimized a formulation for monoclonal antibody MAb B (a biosimilar product to innovator product MAb A) in an iterative way by using typical biophysical tools - dynamic light scattering (DLS), evaporative light scattering (ELS), and differential scanning calorimetry (DSC) - with traditional antibody stability assessment tools: size-exclusion chromatography (SEC) and cation exchange (CEX). However, most tools cannot be used for head-to-head comparison of the biophysical properties of an optimized biosimilar formulation with those of an innovator product at higher concentrations. Currently available biophysical characterization tools can help in screening and optimizing better (more stable) formulations for such products. MALVERN INSTRUMENTS (Biophysical characterization has drawn great attention from the biopharmaceutical industry and regulatory agencies across the globe, especially for use in biosimilar drug product development. Wrap light-sensitive samples in aluminum foil or place them in amber bottles.The Zetasizer Helix system combines Raman spectroscopy with dynamic light scattering. Label the samples properly and wrap them securely to prevent them from spilling.
#Malvern dynamic light scattering free
All glassware and apparatus used for sample preparation must be rigorously clean and free of scratches.Dust contamination to samples usually happens, therefore great care is required in sample preparation.For more information, kindly check the CIF Sample Preparation Website page. The CIF has ultrasonicator probe equipment. This must be applied carefully in order to avoid damaging the primary particles in the sample. Ultrasonication can be used to remove air bubbles or to break up agglomerates in the sample.Avoid gelation, a gel is unsuitable for measurement using the Zetasizer.* DLSP system users refer to DLSU users outside the DLSU Chemistry Department including other schools within the DLSP system *We require that papers for publication using the UV-Vis should acknowledge the DLSU Spectroscopy laboratory. *Charge includes labor for experimental set-up, data processing, print-outs, and electronic data files. Reagents, standards, solvents, and sample preparation must be provided/shouldered/performed by the client.Īdditional charges will be incurred upon the use of zeta potential cuvettes. The fees are inclusive of sample analysis only. Each sample can be analyzed for up to 3 trials each, while sample replicates (in a separate container) and standards are charged as individual samples each. DLSU Innovation and Technology Office (DITO)Īnalysis is charged per sample.DLSU Intellectual Property Office (DIPO).University Research Coordination Office (URCO).Social Development Research Center (SDRC).Lasallian Institute for Development and Educational Research (LIDER).Institute of Biomedical Engineering and Health Technologies (DLSU-IBEHT).College of Science Center for Natural Sciences and Environmental Research (CENSER).Center for Engineering and Sustainable Development Research (CESDR).Southeast Asia Research Center and Hub (SEARCH).Center for Business Research and Development (CBRD).Alfred Shields FSC Ocean Research (SHORE).Advanced Research Institute for Informatics, Computing and Networking (AdRIC).Manufacturing Engineering and Management.Electronics and Communications Engineering.Brother Andrew Gonzalez FSC College of Education.
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