Analytical Methods Development
Scinai CDMO’s experienced team of scientists and state-of-the-art facility ensures accuracy and reliable analytical characterization. We offer advanced analytical methods for in-process control, release testing, and characterization of recombinant proteins.
Laboratory Analytical Capabilities
for identity, purity, and heterogeneity (HPLC -PDA/FD, CE-SDS/cIEF, SDS-PAGE, Western Blot), Immunochemical assays using BLI technology for in-vitro potency and binding affinity (OCTET R8), Endotoxins determination by chromogenic kinetic assay (USP & Ph. Eur. 2.6.14).
Physicochemical methods
Spectrophotometry
for Total Protein Content (Ph. Eur. 2.5.33, Method 2, USP Method IV) . Product and process-related impurities (SEC-HPLC, RP-HPLC, CE-SDS /cIEF) . Particles size analysis (Spectral LUMiSizer).
Host cell protein impurities (ELISA) . Bioburden by membrane filtration (USP ). Stability studies (ICH Guideline Q1A (R2) and Q5C)
Scientists TEAM
Experienced Team of Scientists specializing in Analytical Methods
In-house expertise to characterize, monitor, and optimize your product’s quality attributes across all stages of development.
Dr. Oded Ovadia, PhD
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Director of Analytical Methods & Preclinical Trials Experienced in analytical development of biosimilar and innovative biomolecule
Merav Kamensky, MSc
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Head of Quality Control
Biopharma QC and biological analytical method qualification experience
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