biostudies-literatureUnknown7(1)Zhang XDrug Product Development, Shang Hai WuXi Biologics Inc<h4>Background</h4>Lyophilized drug products with high protein concentration often perform long reconstitution time, which is inconvenient for clinical use. The objective of this work is to achieve short reconstitution time with multiple and combined strategies.<h4>Methods</h4>Here, we describe the following approaches that lead to reduction of reconstitution time, including adding annealing step, decreasing headspace pressure, decreasing protein concentration with reducing diluent volume, increasing high surface-area-to-height ratio of the cakes, increasing frequency of swirling and diluent temperature.<h4>Results</h4>Among these strategies, reducing diluent volume to achieve high protein concentration and reducing headspace pressure show markedly reduction of reconstitution time. MoreoveAntibody therapeutics67-76https://www.ebi.ac.uk/biostudies/studies/S-EPMC10873283biostudies-literatureMultiple approaches to reduce reconstitution time of lyophilized drug products with high protein concentration.PMC10873283Zhou NGuo JZhang XYang CJin ZfalseMultiple approaches to reduce reconstitution time of lyophilized drug products with high protein concentration.<h4>Background</h4>Lyophilized drug products with high protein concentration often perform long reconstitution time, which is inconvenient for clinical use. The objective of this work is to achieve short reconstitution time with multiple and combined strategies.<h4>Methods</h4>Here, we describe the following approaches that lead to reduction of reconstitution time, including adding annealing step, decreasing headspace pressure, decreasing protein concentration with reducing diluent volume, increasing high surface-area-to-height ratio of the cakes, increasing frequency of swirling and diluent temperature.<h4>Results</h4>Among these strategies, reducing diluent volume to achieve high protein concentration and reducing headspace pressure show markedly reduction of reconstitution time. Moreove2024-01-01T00:00:00Z2024 Jan2026-06-12T05:53:16.705Z2024-11-14T13:21:07.281ZS-EPMC108732833837195510.1093/abt/tbad031