Managing Biopharmaceutical Variability without Demanding Manufacturing Sameness through Lifecycle Evidence, Process Understanding, Change Control, and Product Evolution
Year: 2025
Type: article
Abstract: Biopharmaceuticals are heterogeneous products whose molecular distributions may vary across batches, manufacturing sites, process states, storage periods, analytical platforms, and delivery configurations. Lifecycle assurance should therefore focus less on preserving historical manufacturing sameness and more on determining whether product evolution remains compatible with clinically relevant quality, safety, efficacy, exposure, and immunogenicity expectations. This article proposes a non-empiri
DOI: 10.51847/j1cj5gdqva
Authors: Luca Ferraro, Matteo Ricci, Giulia Moretti, Paolo Greco
Subfield: Immunology
Field: Immunology and Microbiology
Domain: Life Sciences
Open Access status: hybrid
OpenAlex ID: W7203758523