Lucideon Supports Bioactivity and Biofunctionality Testing to Enable Regulatory Submission for Biosimilar Product
Case study
Lucideon was engaged by an international client to support their project, which required specialist cell biology testing. The work formed a key part of a regulatory submission involving insulin analogues, where demonstrating bioactivity and biofunctionality through validated in vitro assays was essential. Whilst the client has extensive experience managing pharmaceutical projects, they sought a trusted partner with in-house cell biology expertise to expand their service offering and meet the specific technical requirements of this project.
The challenge
The project required the development and execution of cell-based assays to evaluate the metabolic activity of various biosimilar products of the same category. This included assessment of carbohydrate uptake, lipogenesis, glycogen synthesis, and receptor activation, benchmarked against established reference products such as Lantus, Toujeo, Novorapid, and Novomix.
The testing programme needed to be scientifically robust, clearly documented, and aligned with regulatory expectations.
What we delivered
Lucideon provided a comprehensive testing strategy, covering assay design, optimisation, and delivery of evaluation of the metabolic activity of the various insulin biosimilar products. Experimental conditions were developed to ensure reproducibility, with multiple product batches tested. Functional outputs were collected alongside protein samples for downstream analysis of key effectors of the insulin signalling pathway.
Automated western blotting for receptor phosphorylation, a key part of the analysis, was carried out by an outsource partner under Lucideon's coordination. Throughout the project, interim reports were provided to support timely review and decision-making.
The collaborative approach brought to this project ensured alignment on scientific direction and regulatory expectations, resulting in Lucideon's client being able to offer advanced cell biology testing to their client as part of a broader, integrated solution. Lucideon's scientific oversight and experience ensured the testing met the high standards required for regulatory review.
Value to the client
The collaboration between Lucideon and our client has delivered high-quality, actionable data to support a regulatory submission for insulin-based products. The work was subsequently extended to include final protein analysis, marking another milestone in a highly successful and productive partnership. The collaboration with Lucideon significantly extended the client's capabilities in the expanding field of biofunctionality testing.