Process Development

Our Process Development platform has substantial experience in the optimization and scale up of production schemes in compliance with GMP guidelines.

• Upstream process development (USP)
- Fermentation in batch or fed-batch mode
- Bioreactors in batch, fed-batch and perfusion modes for suspension or adherent cells

• Downstream process development (DSP)
- Cell lysis by high-pressure homogenization
- Clarification by centrifugation, microfiltration, depth filtration
- Purification by chromatography (ionexchangechromatography, hydrophobic interaction chromatography, affinity chromatography, mixed-mode chromatography, etc.)
- Advanced preparation of inclusion bodies
- Refolding processes
- Tangential flow filtration
- Pre-formulation
- Viral clearance

Development of analytical methods and in-process controls (IPC) will be performed by the Analytical team all along the process development phase.

Process Development Philosophy

Process development aims to obtain a robust, reproducible and scalable process scheme which can be transferred to GMP manufacturing. We will specifically focus on:

• Quality of the final product: protein activity recovery of the protein of interest, purity of the final product (protein purity, endotoxin level and residual DNA), oligomeric state/aggregates

• Quality of the overall process: process yield, process duration & cost of goods

• Development & optimization of the production process: optimization of fed-batch and induction strategy,
evaluation of antibiotic necessity, identification of purification scheme and filtration steps, optimization of refolding parameters,
optimization of process parameters (e.g. linear flow rate for chromatography), …