Investigating Liquid Leak from Pre-Filled Syringes upon Needle Shield Removal: Effect of Air Bubble Pressure.

Unlabelled: This study is to investigate the effect of headspace air pressure in pre-filled syringes on liquid leak (dripping) from the syringe needle upon needle shield removal. Drip tests to measure drip quantity were performed on syringes manually filled with 0.5 or 1.

Effect of moisture on the stability of a lyophilized humanized monoclonal antibody formulation.

Purpose: To determine the effect of moisture and the role of the glass transition temperature (Tg) on the stability of a high concentration, lyophilized, monoclonal antibody.

Methods: A humanized monoclonal antibody was lyophilized in a sucrose/histidine/polysorbate 20 formulation. Residual moistures were from 1 to 8%.

A specific molar ratio of stabilizer to protein is required for storage stability of a lyophilized monoclonal antibody.

The selection of the appropriate excipient and the amount of excipient required to achieve a 2-year shelf-life is often done by using iso-osmotic concentrations of excipients such as sugars (e.g., 275 mM sucrose or trehalose) and salts.

Lyophilization of protein formulations in vials: investigation of the relationship between resistance to vapor flow during primary drying and small-scale product collapse.

During the lyophilization process, formulations containing protein, bulking agent, or lyoprotectant form a dry product layer that can affect the transport of sublimed water vapor. We carried out an investigation of the primary drying segment of lyophilization to evaluate the relationship between the resistance to water vapor flow through the dried layer and the microstructure of the dried cake. Recombinant humanized antibody HER2 (rhuMAb HER2) formulated in trehalose was studied, as were protein-free formulations containing trehalose and sucrose.

Preparation of excipient-free recombinant human tissue-type plasminogen activator by lyophilization from ammonium bicarbonate solution: an investigation of the two-stage sublimation phenomenon.

Dry, excipient-free recombinant human tissue-type plasminogen activator (tPA) powder was prepared by lyophilization from ammonium bicarbonate solution. Ammonium bicarbonate sublimes into ammonia, water, and carbon dioxide upon lyophilization, without causing measurable harm to the protein. There were approximately 4 mol of residual ammonium ion per mole of lyophilized tPA.