Quality Analysis & Product Characterization|OPM Biosciences – Cell Culture Media and End-to-End CDMO

Experienced scientists and technical teams equipped with state-of-the-art technologies
Capability of end-to-end analytical method development, product release and characterization, including physical and chemical analysis, binding analysis and cell-based assays
Extensive analytical experience with monoclonal antibodies, bispecific antibodies, fusion proteins, vaccines, ADCs, Virus Like Particles and mRNA etc
Accompanying your biomolecule through the complete CMC development, manufacturing and quality control

Quality Control and Product Characterization of Biologics

Quality analysis and quality control process for CMC of large biomolecule manufacturing

Analytical method development

Quality standard definition

Intermediate product quality control

Release and stability testing

Product characterization

	Content	Analysis
Release	Physical characteristics	Appearance, Color, Clarity, Visible particulates, Subvisible particles, pH, Extractable Volume, Osmolality
	Identity	Peptide Mapping, pI
	Content and Potency	Protein Concentration, Potency
	Purity	SEC, CE-SDS, Charge Variants, PAGE, WB
	Impurity and safety	Bacterial endotoxin, Sterility, Microbial limit, Residual of HCP, HCD, Protein A/L
Characterization	Raw material and ingredients	Identification by IR, HPLC-CAD, etc
	Primary structure	LC-MS (MW, N/C-Terminal, Coverage, PTM, -S-S-, Variant), Glycans, AAA, free-thiol
	Higher-order structure	DSF, IR, CD, Fluorescence
	Binding and Efficacy	SPR, Octet, ELISA, FCM, Epitope binning or mapping
	Function	Cell based assays, ADCC, CDC, Proliferation, apoptosis, phagocytosis etc.

Case Study

N-Glycan profiling, no matter how complex they are

Accurate analysis of post translational modifications (PTM)

System suitability analysis and relative activity analysis of products with different activities

Characterization of Charge Variants: The molecular weight and PTM of each peak were analyzed by preparative iCIEF. Fragments were then collected using FFE for affinity and cell viability experiments