Purpose Mechanical, interfacial, and shear stresses encountered during development, manufacturing and transportation of biologics can compromise monoclonal antibody (mAb) stability. However, most scale-down shaking models often depend solely on orbital agitation and overlook the effect of the solid–liquid interface. To study this gap, stress conditions were applied to simulate early-stage product development and real-world tra...

Biotherapeutic products have revolutionized the diagnosis and treatment of numerous complex to manage diseases, such as cancer, autoimmune disorders, and infectious diseases. When compared with small molecules (pharmaceuticals), this class of therapeutic agents has proven to be more effective and, in general, have fewer side effects. However, they are more expensive (typically 10–1000 times more) and this limits their global a...