Single-use technologies have transformed conventional biopharmaceutical manufacturing,
and their adoption is increasing rapidly for emerging applications like antibody–drug …

To ensure the stability of biologicals over their entire shelf-life, non-ionic surface-active
compounds (surfactants) are added to protect biologics from denaturation and particle …

The principal plastic materials used for the fluid contact and storage in the
biopharmaceutical industry are mainly made up of semi-crystalline polymers, polyolefins …

This publication describes the development of an experimental set-up and testing protocol to
test the hypothesis that filters used for sterile filtration can act as scavengers of leachables …

This paper reports the chemical identity and mechanism of action and formation of a cell
growth inhibitory compound leached from some single-use Erlenmeyer polycarbonate …

Practical issues that arise for high concentration protein formulations can complicate
manufacturing and affect injectability/device compatibility. High concentration protein …

Every manufactured human medicine contains residual impurities associated with its
manufacturing process. Patient safety risk associated with the process-related impurities …

石井 明子, 橋井 則貴, 松本 真理子, 香取 典子, 新井 進, 粟津 洋寿, 磯野 哲也, 井上 友美, 永座 明,
大山 幸仁, 奥村 剛宏, 梶原 大介, 田熊 晋也, 丹下 浩一, 塚原 正義, 筒井 麻衣子, 寺島 伊予, 中川 …