Impact of Annealing and Controlled Ice Nucleation on Properties of A Lyophilized 50 mg/ml MAB Formulation.

We compared "ice-fog" controlled ice nucleation at -6 °C to annealing at the same temperature for a 50 mg/mL monoclonal antibody formulation, using shelf-ramp freezing as a control. Cake structure, drying time, reconstitution time, specific surface area, calculated cake resistance and size exclusion chromatography were all compared. Controlled nucleation resulted in the fastest reconstitution, shortest primary drying, lowest calculated cake resistance, lowest specific surface area and highest moisture content.

Ex Situ and In Situ Characterization of Vaccine Suspensions in Pre-Filled Syringes.

Ex situ and in situ techniques were used to characterize the suspended phase over time for a vaccine drug product supplied in syringes. Micro-computed tomography was used to characterize the suspended sediment in situ in the syringe, while traditional techniques such as particle size distribution, charge (zeta potential), settling rate, and front-faced fluorescence were used to characterize the suspension ex situ. In addition, analytical chemical measurements were conducted in parallel during the course of the study.

The Effect of Shipping Stresses on Vaccine Re-dispersion Time.

A case study is presented for a vaccine drug product (DP) that showed variable re-dispersion times between syringes within a given DP lot and between different DP lots when shipped from the manufacturing site to the receiving site. A simulated shipping study was designed to understand the effect of individual shipping stresses on re-dispersion time and product quality. Shipping stresses simulating shock/drop, aircraft, and truck vibrations were applied separately to 3 syringe orientations, namely tip up, tip down, and tip horizontal (TH).