Continuous Manufacturing Feasibility Studies

Just – Evotec Scientists perform feasibility studies for our partners that have an existing fed-batch process but want to evaluate the performance of their biologic in our continuous manufacturing platform.

Feasibility studies are efficient and low risk activities that are performed with a phased approach. At the end of each phase, stage gates can be added to provide partners with maximum control over the evaluation process.

Cell Line Evaluations

We perform upstream platform assessments on the cell lines our clients have used to produce previous manufacturing lots. During these assessments we run ‘mock perfusion’ cultures in our scale-down models. 

Our goal is to determine whether the existing cell line:

  • Grows well in perfusion conditions
  • Expresses the product with the required quality attributes
  • Delivers high productivity, allowing for a reduction in Cost of Goods Manufactured (COGM)

Our partners have the option to include in the evaluation a comparison against transfectant pools expressing their biologic in our own J.CHOTM High Expression System.

Bioreactor Evaluations in Perfusion Mode

The most promising results from successful ‘mock perfusion’ cultures are then verified in 3 L bioreactor perfusion cultures. Our 3 L bioreactors scale to our 500 L and 1000 L production bioreactors in GMP facilities and so provide considerable insight into commercial-scale performance within our continuous biomanufacturing platform.

We feed perfusate from these bioreactor runs into downstream screening of platform resins and conditions using automated 96-well plate-based and robocolumn technologies. This rigorous screening ensures that the required product quality attributes and impurity profiles will be met by our continuous purification platform.

Cost of Goods Manufactured Modelling Comparison

Our cost modelling experts compare data and assumptions from the fed-batch performance with the data generated during the feasibility study allowing our partners to evaluate the COGM benefits of switching their process to our continuous manufacturing platform operated within our J.POD facilities. 

Our team uses the BioSolve software (Biopharm Services) to model and analyze all aspects of the manufacturing processes. They combine this information with our partners’ assumptions about the likely demand profile for their product to provide a comprehensive view of the potential benefits of switching to continuous manufacturing.