Viral vector manufacturing for clinical trials and commercial supply strictly follows cGMP guidelines. Our facilities were designed to meet ICH guidance, and all equipment is qualified, calibrated, and maintained to ensure good working conditions. Additionally, personnel training, documentation, and raw materials are all fully GMP compliant. This way, we ensure reliable and high-yield viral vector products, meeting rigorous quality control to ensure safety, potency, and consistency.

We aim to develop robust and scalable processes that produce high-quality viral vectors in large quantities. This involves evaluating numerous parameters, including: • Upstream process: selecting the host cell line, optimizing growth media, optimizing infection conditions • Downstream process: optimizing purification conditions, such as chromatography and ultrafiltration parameters • Analytical methods: assay development and analytical assay establishment, customization and development, stability study • Formulation: designing and optimizing the composition and structure of the viral vector We also support our clients’ chemistry, manufacturing & controls (CMC) operations and applications. Our regulatory experts can navigate local landscapes and guarantee comprehensive support, including regulatory strategies, agency communications, documentation filings, inspections, and other tasks to enable regulatory success.

With accumulated experience and a deep understanding of viral vectors, we have developed a platform process that significantly accelerates timelines for manufacturing. Together we will evaluate each project and build a strategy that ensures success.