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 …

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 …

Sugars and polyols have been used routinely with lyophilized proteins and peptides as
bulking agents, cryoprotectants, and lyoprotectants. However, reducing sugars may present a …

Lyophilization is commonly used to dry protein pharmaceuticals to enhance their shelf life.
During the freezing step of this process, significant events (eg pH shifting) can occur in the …

A light microscopy system has been designed for freezing and lyophilization studies of protein
pharmaceuticals. The system consists of a cascade of four Peltier thermoelectric modules …

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 …

Dry, excipient-free recombinant human tissue-type plasminogen activator (tPA) powder was
prepared by lyophilization from ammonium bicarbonate solution. Ammonium bicarbonate …

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 …

E. coli makes use of global transcriptional regulators to survive ever-changing environmental
conditions. The leucine-responsive regulatory protein (Lrp) is one such global regulator …