Combined Effect of Shaking Orbit and Vial Orientation on the Agitation-Induced Aggregation of Proteins.

Orbital shaking in a glass vial is a commonly used forced degradation test to evaluate protein propensity for agitation-induced aggregation. Vial shaking in horizontal orientation has been widely recommended to maximize the air-liquid interface area while ensuring solution contact with the stopper. We evaluated the impact of shaking orbit diameter and frequency, and glass vial orientation (horizontal versus vertical) on the aggregation of three proteins prepared in surfactant-free formulation buffers.

TRYBE®: an Fc-free antibody format with three monovalent targeting arms engineered for long in vivo half-life.

TrYbe® is an Fc-free therapeutic antibody format, capable of engaging up to three targets simultaneously, with long half-life conferred by albumin binding. This format is shown by small-angle X-ray scattering to be conformationally flexible with favorable 'reach' properties. We demonstrate the format's broad functionality by co-targeting of soluble and cell surface antigens.

Development of PLGA microparticles with high immunoglobulin G-loaded levels and sustained-release properties obtained by spray-drying a water-in-oil emulsion.

In this study, the possibility of producing highly antibody-loaded microparticles with sustained-release properties was evaluated. Polyclonal immunoglobulin G (IgG) was used as a model of antibody and its encapsulation into poly(lactide-co-glycolide) acid (PLGA) microparticles was performed by spray-drying a water-in-oil (w/o) emulsion. It was demonstrated that the use of the Resomer RG505 PLGA allowed an IgG loading of 20% w/w with an encapsulation efficiency higher than 85%.

Encapsulation of immunoglobulin G by solid-in-oil-in-water: effect of process parameters on microsphere properties.

Antibodies (Abs) are prone to a variety of physical and chemical degradation pathways, which require the development of stable formulations and specific delivery strategies. In this study, injectable biodegradable and biocompatible polymeric particles were employed for controlled-release dosage forms and the encapsulation of antibodies into polylactide-co-glycolide (PLGA) based microspheres was explored. In order to avoid stability issues which are commonly described when water-in-oil (w/o) emulsion is used, a solid-in-oil-in-water (s/o/w) method was developed and optimized.