“…Biologics having high molecular weights (i.e., insulin 5.8 kDa; Humira consisting of 1330 amino acids, and MW 148 kDa) and high concentrations per milliliter (mg/mL) and their means of delivery as opposed to small molecular weight drugs (i.e., epinephrine 183 Da) are associated with many challenges including their rheology. With advances in formulation design, the complexity of the formulations that are designed to enhance the solubility of insoluble drugs and provide greater stability for concentrated biologicals which tend to undergo aggregation, deamination, denaturation, hydrolysis, or oxidation has also changed dramatically (2)(3)(4). Multiple excipients, agents, and environmental factors have been investigated that can ensure both physical and chemical stability of biopharmaceuticals including the use of small sugars such as trehalose (5,6), dextran (7), surfactants like pluronic, polysorbate (8), and influence of pH, temperature, and ionic strength.…”