ABSTRACT
INTRODUCTION Because of the rapid advance inmolecular biology, immunology, andmicrobiology over the past decades, biological therapeutics has become a major category of drugs in clinical applications to date.While biological drugs possess great advantages in terms of therapeutic potency and target specificity, their structural instability has been a long-standing issue in formulating these macromolecules into convenient dosage forms. To avoid denaturing in formulation processes and shelf life, preconverting biotech drugs into solid particles is widely accepted as a useful unit operation. However, the particle-forming processes themselves must not be hazardous to the susceptible structures of biologicals.
