Jian Liu

TL;DR: An effective extraction solvent system was developed to evaluate the organic extractable profiles of single-use bioprocess equipment, which has been gaining increasing popularity in the biopharmaceutical industry because of the many advantages over the traditional stainless steel-based bioreactors and other fluid mixing and storage vessels.

TL;DR: Wang et al. as discussed by the authors proposed an active and smart biomass composite film with favorable multifunctionality by incorporating the oxidized cellulose nanofiber (OCNF)-stabilized cinnamon oil (CNO) Pickering emulsion and curcumin (Cur) into gelatin/chitosan (GC) film matrix.

TL;DR: A rapid and sensitive approach was developed for direct detection of BdtbPP and other leachables from SUBs using DESI-TOFMS, which indicates the usefulness of the proposed method as a qualification tool for SUBs in biopharmaceutical development and also its great potential in the analysis of extractables/leachables in a wide variety of materials, process components, devices and containers used in the pharmaceutical industry.

TL;DR: In this paper, an extractable and leachable study design consisted of twelve drug products filled in twelve different size glass vials capped with laminated and nonlaminated rubber stoppers made from three different rubber formulations.

TL;DR: The comprehensive extractables and leachables data presented demonstrate and substantiate a holistic extractable and leachable program designed to ensure product quality and patient safety from prefilled syringes.