Process Development
We provide comprehensive process development services to help transition your research-grade process into a scalable, cGMP-compliant manufacturing process for cell and gene therapy.
Over the past two decades, gene therapy research and development have advanced significantly. The biopharma industry faces an increasing demand for viral vectors in cell and gene therapy, with heightened expectations for higher quality, improved manufacturing processes, higher titers, and greater yields.
To meet these challenges, Andelyn’s process development scientists focus on creating cost-effective, robust, and scalable platforms that support both clinical and commercial applications. By integrating quality-by-design (QbD) principles, we help accelerate timelines, optimize costs, and ensure reliable manufacturing processes from early-stage development to large-scale production.
Our team remains at the forefront of innovation, continually evaluating emerging technologies and developing new strategies to improve production, purification, and product quality. Collaborating closely with the analytical development group, we implement orthogonal analytical methods to ensure comprehensive product characterization at every step of the process, avoiding reliance on a single technique.
This commitment to excellence empowers us to deliver tailored, scalable solutions that advance the field of cell and gene therapy while meeting the demands of both early-stage and large-scale programs.
Process Optimization for Suspension and Adherent Systems
- Use scale-down models for efficient production processes.
- Optimize yield/recovery, capsid separation, and critical quality attributes.
- Ensure reproducibility, scalability, and smooth transfer to cGMP manufacturing.
Critical factors for optimization
- Enhance cell culture with better cellular factors
- Refine media factors for long-term scalability
- Optimize transfection reagents and DNA factors
- Improve harvest factors for better recovery and process performance
- Purify raw materials with clarification factors
- Ultrafiltration/diafiltration for purity and efficiency
- Refine chromatography using specialized column chemistries
- Use ultracentrifugation for precise viral vector production
- Create stable products with optimized buffer factors
Our Approach
Data-driven process optimization leveraging decades of production data to minimize the number of process parameters and conditions that need to be assessed—ensuring cost-effective and improved manufacturing for clinical and commercial success.
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.