Critical Quality Attributes to Advance Therapeutics and Vaccines from Candidate Selection to Drug Product
Biotherapeutics and vaccines are critical in improving public health. They are being developed for acute and chronic clinical indications that cover the spectrum from infectious diseases to oncology. The development of biologics, from candidate engineering and selection, through expression, purification, formulation, analytical characterization and finally delivery to patients, is a highly interdisciplinary scientific field. We joined other thought leaders at the Biotherapeutics and Vaccines Development (Gordon Research Conference) to discuss the development and characterization of monoclonal antibodies (mAbs), and other molecules, like bi-specifics, peptides, fusion proteins, antibody-drug conjugates etc.
We took the opportunity to introduce Microfluidic Modulation Spectroscopy (MMS) to the discussion. MMS is a novel and efficient technique for label-free protein analysis that directly addresses the limitations of current technologies. MMS provides drift-free, background subtracted, high sensitivity measurements of the protein secondary structure across four decades of concentration—from 0.1 to over 200 mg/mL.
If you are interested in learning more about the use of MMS to characterize ADCs, then this article from Karan Shah at Immunogen, is a great read