Gene Therapy Process Development Support To Optimize AAV Yield & Quality From Gene To GMP Production

We empower your team to reach new heights with our comprehensive and collaborative approach to delivering custom process development (PD) solutions efficiently and effectively. With expertise in AAV development and manufacturing dating back to 1991, we offer a wealth of knowledge to support your needs.

Our global onboarding and tech transfer capabilities ensure seamless integration, while our robust risk analysis and mitigation strategies optimize both upstream and downstream processes. Leveraging a design of experiments (DoE)-driven approach, we conduct extensive process characterization with over 50 analytical assays. Our scalable bioreactor platforms, ranging from 15mL to over 200L, are paired with high-producing host cell options to maximize yield and efficiency.

Additionally, we provide innovative solutions for cell lysis and viral safety, ensuring robust and reliable production. From feasibility and comparability studies spanning clinical to commercial phases to comprehensive CMC regulatory support and guidance from R&D through IND/IMPD submission, we are committed to driving your success at every stage.