JP3 Process & Product Development

The process development team at Just – Evotec Biologics develops manufacturing processes for antibody and antibody-related biologics using our unique continuous manufacturing platform.

Our scientists develop high productivity cell lines expressing your biopharmaceutical candidate at high levels using our J.CHO^TM High Expression system. Our proprietary cell lines and vectors can deliver productivities of over 4 g/L/day and the product quality attributes you require.

In addition, we have extensive experience working with CHO (Chinese Hamster Ovary) cell lines from third parties, seamlessly integrating them into our upstream platform perfusion process and optimizing their performance.

We employ state-of-the art tools for upstream process verification, including:

• Mock perfusion cultures in microwell plates
• 3 L and 50 L perfused, continuous harvest bioreactors

Our 3 L and 50 L bioreactors scale readily to 500-L and 1000-L production-scale bioreactors. 

Just – Evotec Biologics scientists use these tools to carefully assess:

• Growth characteristics
• Productivity
• Metabolite consumption
• Product quality attributes

The material generated during these runs can be used for:

• Clone selection
• Product quality analysis
• Downstream process development
• Analytical development
• Formulation development

Our downstream process development is tailored to ensure that the final drug substance meets all specifications. Utilizing the Just-Evotec Biologics platform, we develop a purification process that is specific to our partner’s product. The purification process developed will incorporate a continuous capture and virus inactivation step for first-in-human manufacturing and early clinical development. During commercial process development, our teams can develop an end-to-end fully continuous downstream process to reduce Cost of Goods.

• Rapid, automated 96-well plate-based screening and robocolumn screening of platform resins and conditions, as well as alternative resins if needed.
• Bench-scale chromatography systems for development of batch and continuous operation

• Bench scale development of depth filtration and viral filtration to support batch or continuous process operation
• Bench scale development of batch ultrafiltration/diafiltration or continuous in-line concentration/diafiltration for final formulation

In addition, our experts develop low pH or detergent viral inactivation conditions, depending on the needs of your molecule.