Preclinical Production

In R&D, as well as in preclinical development, it is critical to have a reliable and steady supply of candidate material for evaluation and assays. Typically, smaller quantities of material from multiple candidates are needed early on for in vitro and cell-based assays, whereas later on, considerably larger quantities of material from fewer candidates are needed for animal studies. The Selexis SUREtechnology Platform offers several options for generating the necessary amount of material for each step during the evaluation process.

Selexis SUREpools and Selexis SUREclones

Selexis SUREpools are a time, and cost-effective approach when protein is needed for up to 500 candidates for screening in in vitro and cell-based assays. When more material is needed for larger studies, Selexis routinely generates sufficient material (100-500 mg) on the 0.5-1-L scale. Selected candidates can be transferred to the Selexis SURE Cell Line Development Platform to generate higher-producing clonal cell lines-the Selexis SUREclones-ready for cGMP manufacturing.

The Selexis approach eliminates the need to perform multiple transfections of candidate genes and minimizes variabilities in protein expression and post-translational modifications throughout the screening process. Once Selexis SUREpools have been established, all subsequent cell lines are subclones of that population. The protein candidates are expressed in the manufacturing cell line; so, once a clinical candidate is chosen, the cell line can directly enter master cell banking (MCB).

By using the Selexis SUREtechnology Platform from discovery through GMP biologics manufacturing, it is possible to:

  • Reduce timelines
  • Lower costs
  • Increase efficiencies
  • Ensure consistent product quality
  • Improve and accelerate decision-making