After your established process development, the next milestone in your product life cycle is to ensure your gene and cell therapy product succeed in regulatory application and future commercialization.
With a systemic, standardized manufacturing strategy and a proven and predictable path, you will be able to commission our cGMP suites, airflows, material storage, documentation processes, quality systems, and experienced engineers to take your products to market at a faster pace. Leveraging our large-scale cGMP manufacturing platform and single-use technologies, we will provide you cGMP manufacturing services from pre-IND all the way to commercialization, and are able to flexibly complete co-line manufacturing of various products, enabling you to adjust to demand changes in a more efficient and reliable way.
With a successful IND declaration as the millstone, we provide our Pre-IND services and Post-IND services as our CDMO solutions.
The current operating manufacturing footprint at OBiO covers of a pilot testing platform of +1,000 sqm, and a three-building cGMP manufacturing platform with +10,000 sqm in total. Furthermore, we have constructed OBiO Intelli-M site with 77,000 sqm cGMP footprint, 33 cGMP production lines, and up to 2,000 L bioreactor capacity at Shanghai Lin-Gang Free Trade Zone to satisfy the global demand of gene and cell therapy products.