Molecule and Manufacturability Assessment Leading to Robust Commercial Formulation for Therapeutic Proteins

The transfer of lead molecules from discovery into process development at a relatively fast pace requires a process of candidate selection that assesses if a candidate is not only active and safe but also “manufacturable.” Formulation and process stability of potential candidates help narrow down lead candidates at an early stage, prior to large-scale manufacturing, by a process of rank-ordering properties generated from process and long-term stability studies. Such an assessment of the molecules’ manufacturability is especially useful when binding affinity and bioactivity are comparable among the various candidates under question. This chapter reviews several case studies that explore the utility of early-stage molecule or manufacturability assessments in moving forward therapeutic candidate/s by finely balancing potency and pharmacokinetics with the manufacturing capability of the candidate/s under question.