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ANALYTICAL CHARACTERIZATION OF PHARMACEUTICAL AND BIOLOGIC NEW CHEMICAL ENTITIES

Characterization of a pharmaceutical or biological entity includes analysis of its structure, activity, stability, potency and behavior in a formulation. A well-characterized drug product reduces the risk of unknowns. For example, any process impurities, intermediates or excipients which might affect the product’s potency could go undetected in the absence of a complete characterization program.

Bioanalytical Laboratory Testing at Pacific BioLabs

The analytical and bioanalytical laboratory at Pacific BioLabs has over 20 years of experience in developing and validating methods for characterization of pharmaceuticals, biologics and conjugates to support initial lead candidate selection through downstream manufacturing. With its team of chemists and scientists and state-of-the-art instrumentation, our bioanalytical laboratory has performed characterized well over 400 small molecules and biologics.

Notably, our team has characterized a whole spectrum of biological products including enzymes, carbohydrates, peptides, antibodies, PEGylated proteins, vaccines, and antibody-drug conjugates.

NCE Analytical and Bioanalytical Services Offered

  • Evaluation of Purity, Stability, Potency, Concentration and Solubility
  • Identity Assays
  • Structure Elucidation
  • Peptide Mapping by Protease Digestion
  • Analysis of Post Translational Modifications such as Glycosylation
  • Extinction Coefficient Determination
  • Immunoassays
  • Analysis of Degradants, Residual Solvents, Process Impurities and Intermediates
  • Analysis of Heavy Metals and Trace Contaminants

NCE Analytical Instrumentation

  • HPLC
  • Size-Exclusion Chromatography (SEC)
  • Laser-Light Scattering
  • GC
  • GC/MS
  • LC/MS/MS
  • ICP-MS
  • ELISA
  • SDS-PAGE
  • Isoelectric Focusing (IEF)
  • Instrumentation Details

New Chemical Entities Regulations and Standards

New Chemical Entities Related Testing

Read More about New Chemical Entities

 

 
 
 
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