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

  • Director of Analytical Methods & Preclinical Trials Experienced in analytical development of biosimilar and innovative biomolecule

Merav Kamensky, MSc

  • Head of Quality Control

     Biopharma QC and biological analytical method qualification experience

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