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Brochure

Rigorous and Comprehensive Analytics to Support Biologics Discovery and Development

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Bioanalytical testing is a critical component to all successful drug discovery and development programs. IND-enabling studies require that biotherapeutic proteins, or biologics, undergo rigorous testing to increase the likelihood of being developed into drug products. Using a set of biochemical and biophysical assays, the purity, structural integrity, and chemical stability of potential biotherapeutics are established and used to determine the candidates with favorable profiles to advance or redesign. Aragen Analytics capabilities include CE-SDS, cIEF, SEC-HPLC/MALS, LC/MS, DLS/SLS, LAL, HIC, HILIC, and SPR/BLI.

Early Analytics for selection of Clones:

Incorporation of analytics at an early stage of cell line development accelerates right clone selection, leading to a significant reduction of the project timelines and resource requirements. Employing cIEF to eliminate the undesired basic peak clone (clone A) that do not overlay with the innovator.

Protein Analytics Quality Attribute Platform
Protein concentration by A280 Quantity UV-Vis
A280, A320, Appearance General- Appearance, Trubidity
Free-thiol by Ellman’s assay Primary Structure – Free thiol
Enzyme kinetics (kcat,kcat/KM) Potency
N-Glycan profiling by CE Primary Structure – PTMs SCIEX PA 800 Plus
Charge variants by clEF Purity – Charge variants
Charge variants by CZE Purity – Charge variants
Size variants (fragments) by CE-SDS Purity – Size variants

  

Protein Analytics Quality Attribute Platform
Slab gel IEF Purity—Charge variants Gel Electrophoresis
SDS-PAGE (non-reduced and
reduced)		 Purity —Size variants Identity
Western blot Identity
Binding kinetics (kon,koff, KO) Potency, Identity BioLayer
Interferometry
(BLI) ForteBio
Octet RED
or
Surface Plasmon
Resonance (SPR)
Biacore
Molecular
Decices
SpectraMax
FcR and C10, binding Half-life, Safety
Protein concentration,
antigen binding titer		 Quantity
Epitope binning Epitope characterization
Functional blocking Potency Identity
Yes/No binding Identity
Binding ELISA Potency
HCP ELISA (Cygnus) Safety
Residual Protein A/G/L by ELISA Safety
Endotoxin by Limulus
Amebocyte Lysate (LAL)		 Safety Charles River
EndoSafe
Culturing
Bioburden, Sterility Test Safety