Characterization of Pharmaceutical and Biologic NCEs
Novel drugs under clinical development are often innovative new entities that have not been previously approved by the Food and Drug Administration (FDA). These drugs are generally divided into two main classes identified as either a new chemical entity (NCE) or a new biological entity (NBE); however, additional classes have also been designated based on the chemical make-up/structure of the entity. During the course of the development cycle of NCEs and NBEs, full characterization often includes elucidation of the structure, stability, potency, and other attributes that may be required for FDA approval. A well-characterized NCE or NBE reduces the risk of unwanted and/or unintended consequences to patients in clinical settings.
Analytical and Bioanalytical Laboratory Services at Pacific BioLabs
Pacific BioLabs Analytical and Bioanalytical Services Department has over 20 years of experience in developing and validating methods for characterization of Sponsor NCEs and NBEs from initial lead candidate selection through downstream manufacturing. With its team of chemists and scientists and state-of-the-art instrumentation, characterization of over 400 NCEs and NBEs has been performed to date. This includes but is not limited to a whole spectrum of small molecules and biological products including enzymes, carbohydrates, peptides, antibodies, PEGylated proteins, vaccines, and antibody-drug conjugates.
NCE Analytical and Bioanalytical Services Offered
- Analytical Chemistry and Bioanalytical Method Development and Validation
- Evaluation of Purity, Stability, Potency, Concentration and Solubility
- Identity Assays
- Structure Elucidation of Unknown Purities and Degradants
- Protein Characterization
- Disulfide Mapping
- 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
- TOF-/MS
- ICP-MS
- ELISA
- MSD-ECLA
- SDS-PAGE
- Isoelectric Focusing (IEF)
- Instrumentation Details