Plant-Made Biologics

The increasing world demand for human biologics cannot be met by current production platforms primarily based on mammalian cell culture due to prohibitive cost and limited scalability. Recent progress in expression vector development, downstream processing, and glycoengineering has established plants as a superior alternative for biologic production. Plants offer not only the traditional advantages of proper eukaryotic protein modification, low cost, high scalability, and increased safety, but also allow the production of biologics at unprecedented speed to control potential pandemics with specific glycoforms for better efficacy (biobetters). The recent approval of the first plant-made biologic (PMB) by the FDA for treating Gaucher’s disease heralds a new era for PMBs and sparks new innovations in this field. This special issue invites original research and review articles that report the recent developments and application of PMBs. Potential topics include, but are not limited to: Expression vector and platform development Plant production host development Novel biologic products (e.g., biobetters and biosimilars) Glycoengineering and posttranslational modification Downstream processing and purification Analytical method development Product functional characterization Clinical testing cGMP and commercialization Regulatory compliance and intellectual property Economic impact and evaluation