Analytical Method Development & Protein Characterization
Analytical method development and protein and antibody characterization takes into consideration safety, identity, potency, and purity. It is essential to develop and validate analytical methods to measure levels of a drug (pharmacokinetics) in human serum, as well as to detect the presence of neutralizing antibodies typically generated by a patient’s immune system against a protein-based drug during the clinical trial. Analytical methods to ensure safety, purity and efficacy of the drug candidates during the manufacturing process must be qualified during the drug development process before entering clinical trials.
Analytical Method Development and Antibody Characterization Capabilities
Goodwin Biotechnology provides a complete array of routine testing, assay development for biologics, validation of cell-based assays employing techniques to characterize biopharmaceuticals including monoclonal and polyclonal antibodies, recombinant proteins, fusion proteins, antibody drug conjugates, and vaccines such as:
- HPLC (Reverse Phase, Size Exclusion, Ion-exchange, Hydrophobic (HIC), Hydrophilic (HILIC)
- ELISA (potency, host cells proteins, residual contaminants)
- Gel electrophoresis (SDS and IEF)
- Capillary electrophoresis (CE SDS and icIEF)
- Western Blot analysis
- Protein concentration (by UV, colorimetric)
- Fluorescence Spectrometry
- Tryptic Mapping & N-Glycan Analysis
- Measurement of the ratio of protein to a chelating agent, drugs, dyes, ligands (for bioconjugation processes)
- Octet (binding kinetics and concentration of antibodies in cell culture harvest) or Pro A HPLC for product titer
- Cell-based assays (Potency)
- Identification of raw materials per USP and EP monograph
- Pharmacopeial testing methods such as pH, osmolality, conductivity, extractable volumes, appearance, A280nm, and bioburden
- Designing of assay control strategy, specifications, and assay troubleshooting
- Product stability studies including In-process intermediate hold stability (during purification process), freeze-thaw stability, limited or extended forced degradation stability, and preformulation buffer stability studies.
- Method transfer (from you) and development/optimization
Dr. Kim Mendes, Ph.D.
Director, Protein Characterization & Bioconjugation Process Development
Dr. Mendes brings over 15 years of experience in protein and antibody characterization as well as significant expertise in expression and purification of recombinant proteins; chromatographic separation (ion-exchange, size exclusion, hydrophobic interaction, immobilized metal affinity); Spectrophotometric assays (UV/Visible, fluorescence spectrometry, stopped-flow, fluorescence polarization, chemiluminescence); protein and antibody bioconjugation techniques; enzymatic assays including titration, kinetics, and inhibition; dialysis; microarray technology (nanoprinting, glass microarray slide preparation, hybridization); flow cytometry; immunochemical assays; ELISA; high-throughput one-bead one-compound bead screening. She also has experience with Molecular Biology, X-Ray Crystallography and Chemical Synthesis.
After earning her undergraduate and PhD degrees in Chemistry at Boston College, Kim worked as a Senior Staff Scientist at OPKO Pharmaceuticals where she managed a team of scientists who screened diverse chemical libraries to identify novel biomarkers for the development of blood based diagnostic tests for a wide range of diseases. Prior to that, she worked as a Staff Scientist at The Scripps Research Institute where she was developing a high throughput Alzheimer’s diagnostic test. She also did her Postdoctoral work at Scripps where she synthesized diverse peptoid libraries to screen for their binding ability to a variety of protein targets.
What Clients Say
Being a smaller company, we found (Goodwin) to be flexible in their approach and a very good fit for RadImmune. They transparently develop sound process development, manufacturing, and product characterization strategies, and have a long history of overcoming challenges while maintaining a rapid development timeline”
Your biopharmaceutical candidate
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