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.

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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

Profile of

Anthony Rowe

Manager, Protein Characterization

Anthony leads a dynamic group of technically proficient and analytically-minded scientists as the Manager of the Protein Characterization team. In his role, Anthony leverages his 8+ years of Biotherapeutic characterization and Assay Development experience to provide comprehensive Client assay tech transfers and assay verifications into the Quality Control/Verification stage. Previous assay development and QC work in the Immunotherapeutic (mAb and bispecifics), Biologic, Cell Therapy and Regenerative Medicine arenas allows Anthony a broad and knowledgeable base from which to provide insight, design and troubleshooting for various projects. The Protein Characterization team at GBI prides itself on delivering quick turnarounds and thoughtful project data review at a level unmatched by other CDMOs.

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”

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The Goodwin Approach

Goodwin’s advantage:

  • cGMP compliance with strong regulatory track record
  • Flexible and responsive
  • Specialize capabilities with complex biologics
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049 Schedule

Your biopharmaceutical candidate

For more information on how we can characterize your biopharmaceutical candidate