The clinical efficacy and safety of therapeutic monoclonal antibodies (mAbs) are significantly affected by their Fc-glycosylation profile. High mannose-type N-glycans (HM) affect efficacy (in terms of antibody-dependent cell cytotoxicity), pharmacokinetics, and stability. While in endogenous IgGs the HM levels are very low, they are significantly higher in marketed therapeutic mAbs. In order to meet the demands for late-phase clinical trial and market supply, process intensification is required. Since glycosylation profiles are sensitive to process variations and changes, controlling HM levels in robust manufacturing processes presents a formidable challenge and requires a thorough understanding of the cellular processes as well as the biotechnical aspects that govern the production of HM glycans.

治疗性单克隆抗体（mAb）的临床疗效和安全性受到其Fc-糖基化特性的显着影响。高甘露糖型N聚糖（HM）影响功效（就抗体依赖性细胞的细胞毒性而言），药代动力学和稳定性。虽然内源性IgG中的HM水平非常低，但在市售的治疗性mAb中却明显更高。为了满足后期临床试验和市场供应的需求，需要加强工艺。由于糖基化概况对工艺变化和变化敏感，因此在稳健的生产工艺中控制HM水平提出了巨大的挑战，并且需要对细胞过程以及控制HM聚糖生产的生物技术方面有全面的了解。