Process Development
We offer comprehensive process development services designed to seamlessly transition your research-grade process into a scalable, cGMP-compliant manufacturing process.
- Process optimization for Suspension and Adherent leveraging scale-down models
- Optimization for increased yield/recovery, full capsid separation and specific purity requirements
- Focus on reproducibility, scalability and transferability to cGMP manufacturing
Critical factors for optimization
- Cellular Factors
- Media Factors
- Transfection Reagent
- DNA Factors
- Harvest Factors
- Clarification Factors
- Ultrafiltration/Diafiltration Factors
- Chromatography Factors Including Column Chemistries
- DNA Factors
- Ultracentrifugation
- Formulation uffer Factors
Our Approach
Data driven process optimization leveraging decades of production data to minimize number of process parameters and conditions that need to be assessed.
Enabling Your Program
Andelyn Feasibility Study
Andelyn's small-scale feasibility studies enable you to generate data that drive decisions and help draft your manufacturing roadmap from GMP to commercial scale.
Andelyn Development Center
Explore the heart of innovation at the Andelyn Development Center (ADC), where groundbreaking research, meticulous process development, and advanced analytical capabilities converge. As the cornerstone of Andelyn’s capabilities, ADC expands horizons and meets the evolving demands of our clients.
Seamless Transition to cGMP Manufacturing
Once your process is optimized, Andelyn's seamless transition to cGMP manufacturing ensures consistent quality and efficient scale-up. Our state-of-the-art facilities and experienced team maintain the integrity of your process while meeting the highest regulatory standards.
Rigorous Analytical Testing Throughout Development
Our comprehensive suite of analytical services is embedded within your process development journey. This ensures continuous monitoring, characterization and quality control allowing for informed decision-making at every stage.