For biosimilar developers, cell culture performance has two linked dimensions: how efficiently cells produce an antibody and how closely that antibody matches the quality profile of the originator product. Media composition can influence both. Understanding this relationship helps you evaluate supplements according to their contribution to the intended process and product profile.
Use product quality to guide media development
Basal media and feeds influence glycosylation as well as cell growth. In a study of a HER2-binding biosimilar candidate, optimizing the medium and feeding strategy brought its glycan profile closer to that of the reference product [1]. Research has also linked upstream media composition to aggregation in purified antibodies during accelerated stability studies [2]. Together, these findings support assessing ingredients through both cell culture performance and the quality of the antibody produced.
Novo Nordisk Pharmatech’s Recombinant Insulin is manufactured under cGMP, following EU GMP Part II/ICH Q7, and meets the European and United States Pharmacopoeia monographs for human insulin. ISO 9001 quality systems, manufacturing traceability and comprehensive documentation further support raw material qualification, helping biosimilar manufacturers build quality into their processes from early media development onward.
Explore recombinant insulin within your formulation
Recombinant insulin is a defined, animal-free supplement that can support CHO cell growth and antibody production. Our study showed that across three chemically defined media, insulin supplementation led to up to 1.7-fold higher Trastuzumab production relative to the corresponding insulin-free control, at the best tested condition. The insulin response depends on the cell culture system, thus fine-tuning of insulin concentration is a vital step of process optimization that directly translates into process efficiency and higher antibody yields. Explore the CHO-S study
Support commercial scale with supply confidence
Large-scale biosimilar manufacturing depends on a robust supply chain that can keep pace with increasing raw material requirements and demanding production schedules. Novo Nordisk Pharmatech combines Recombinant Insulin with a secure, traceable supply chain and dependable delivery to support continuity from development to commercial production. This provides manufacturers with a reliable basis for planning campaigns, managing supply risk and meeting commercial demand.
Let’s discuss how our recombinant insulin can improve your CHO cell culture media formulation. Our Field Application Scientist team helps support your process development needs to maximize antibody yields.
References
[1] Xu et al. Scientific Reports (2021). 10.1038/s41598-021-86447-0
[2] Purdie et al. Biotechnology Progress (2016). 10.1002/btpr.2289
