Critical Quality Attributes to Advance Therapeutics and Vaccines from Candidate Selection to Drug Product

Biotherapeutics and vaccines play a critical role in improving public health globally. They are being developed for acute and chronic clinical indications that cover the spectrum from infectious diseases to oncology, including respiratory/auto-immune, cardio-vascular, gastro-intestinal and neurological disorders. The development of biologics, from candidate engineering and selection, through expression, purification, formulation, analytical characterization and finally delivery to patients, is a highly inter-disciplinary scientific field. This field lies at the interface of Immunology, Virology, Molecular Biology, Biochemistry, Biophysics, Bio-Chemical Engineering, Pharmaceutical Sciences, Protein Chemistry, etc., and is governed by critical expectations of key regulatory agencies, viz., US FDA, EU EMA and Japan PMDA.

The mission of this new GRC is to assemble subject matter expert (SME) scientists from each of these fields to collectively tackle the highly inter-disciplinary fundamental scientific challenges underlying the development of biotherapeutics and vaccines. Unlike other conferences, which tackle the continuum of development in a piecemeal fashion, e.g. separate purification or formulation/analytics streams, this GRC assembles all SMEs together in a cross functional meeting that reflects the inter-disciplinary scientific/engineering challenge of biotherapeutic and vaccines development. Expression and purification strategies often impact drug product critical quality attributes, whose influence cascades into the bio-physical measurements, interpretation of data and decision-making by formulation, analytical, delivery and process design experts. Moreover, while diverse constructs are under clinical development, the same construct, e.g., monoclonal antibodies (mAbs), can be applied as therapeutics and prophylactics. Given the prolific clinical development of mAbs, cross-learning is of paramount importance to facilitate non-incremental advances in this field. In addition to mAbs, development of other molecular constructs, e.g., bi-specifics, peptides, fusion proteins, antibody-drug conjugates etc. will be discussed.

This GRC welcomes all interested scientists from the biotech/bio-pharma industry, academia, private/government research labs, non-profit organizations etc. Post-doctoral scientists and graduate students are especially encouraged to attend and everyone is expected to participate in the lively discussions that characterize GRCs! While talks are by invitation only, attendees are requested to present posters on their research. Poster sessions will be organized in the afternoons.