ABSTRACT
Biologic drugs include proteins, peptides, and nucleic acids used in prophylactic or therapeutic applications. The use of insulin for type 1 diabetes mellitus is perhaps one of the oldest uses of protein therapeutics. The modern repertoire of protein drugs also includes monoclonal antibodies (mAbs) and antibody drug conjugates (ADCs) among others. Polypeptides with more than 30 amino acids are typically defined as large molecules or biologics. In the body, an antibody is a protein produced by ß-lymphocytes in response to substances recognized as foreign (“antigens”). Antibodies recognize and bind to antigens, resulting in their inactivation or opsonization or complement-mediated destruction. Biologic drug substance and drug product manufacturing processes must take into consideration the physicochemical characteristics of these molecules to ensure their stability throughout manufacture. Most therapeutic proteins are administered as aqueous solutions. Therefore, achieving and maintaining solubility is a key requirement for the manufacture, storage, and use of these biologic drugs.
