Biomanufacturing and characterization of the ever increasing cadre of complex modalities (protein therapeutics, enzymes, antibody-drug conjugates, bispecifics, fusion proteins, vaccines, etc.) are approaching a turning point where disruptive technology may be necessary to advance the next generation. Each molecular class brings with it new challenges in elucidation of structure, mechanism of action, stability, and immunogenicity. Such analytical and biochemical challenges are coupled with regulatory considerations that must be met to ensure safety and efficacy. We look forward to developing innovative approaches toward production/characterization of next generation biotherapeutics, complex dataset integration and its impact on biosimilarity, structure-function correlations, and de-risking of innovative technologies for lifecycle appropriate implementation and regulatory assimilation. In addition, with the advent of new manufacturing technologies (e.g. single use and continuous processing), there is an ever increasing need for streamlined manufacturing. Therefore new technologies to support the circular ecomonmy and/or cost-effective manufacturing are desirable. A wide variety of research tools and expertise are available, including high resolution mass spectrometry, ultrahigh performance liquid chromatography, capillary electrophoresis, molecular biology suites, and a myriad of additional optical/NMR spectroscopic instruments.

 

key words

Capillary electrophoresis; Biosimilar; Bioactivity; Bioassay; Monoclonal antibody; Biotherapeutic; Biopharmaceutical; Glycan; Glycopeptide; Glycoprotein; Glycosylation; Vaccine; Post-translational modification; Mass spectrometry; Membrane protein; Chromatography; HPLC; MS, Fusion protein; Machine learning; NISTmAb;

Citizenship:  Open to U.S. citizens

Level:  Open to Postdoctoral applicants