The goal of downstream process development is to reduce product-related impurities (aggregates, fragments, charge variants) and process-related impurities (host cell protein, host cell DNA, and residual resin ligands) to industry standards with high throughput and recovery. Leveraging our deep knowledge and extensive experience, we design and optimize scalable and robust downstream process. After process development, the process will be scaled up either a 100L or 200L pilot scale before manufacturing at GMP production scale.
Experienced: We have extensive experience developing purification processes for monoclonal and multi-specific antibodies, nanobodies, and other recombinant proteins. Leveraging our previous successes, we offer several platform processes to achieve high throughput and high resolution for your products.
High Quality: We conduct OFAT (One Factor At a Time) and DOE (Design of Experiments) studies to optimize process parameters and enhance process performance. Additionally, we perform Intermediate hold time and load capacity studies to ensure consistent product quality at scale.
Continuous Process: We have successfully developed and implemented continuous production process. We can develop continuous capture and polishing processes from the beginning or transform a batch process into continuous mode.
High Efficiency: For over 90% of projects, the overall yield of the target molecule is greater than 70%.
Fast: For the majority of projects, we can establish efficient and scalable downstream process within 3 months of receiving representative materials.
• Resin and filter screening
• Process development and optimization
• Viral clearance study
• Technology transfer & process scale-up
• Late phase process optimization & characterization