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.

End-to-End Offering

With a successful IND declaration as the millstone, we provide our Pre-IND services and Post-IND services as our CDMO solutions.

Process Development

Analytical Method Development

Scaling / Manufacturing / Releasing

IND-Enabling CMC Supports

Pre-clinical Efficacy Studies

Clinical Manufacturing

Commercial Manufacturing

Pre-IND service

Post-IND service

Pre-IND service

Clinical manufacturing service (for Phase I, II, III)

With the single-use and large-scale manufacturing technologies as the core, our cGMP platform can facilitate the manufacturing and quality control of clinical gene and cell therapy samples in strict accordance with regulatory requirements at multiple countries, and meet the gene and cell therapy sample demands for phase I, II and III clinical trials.

Commercial manufacturing

We provide commercial manufacturing services for marketed gene and cell therapy products at our OBiO Intelli-M site.

Post-IND extended services

We provide a wide range of Post-IND extended services covering technology transfer consultation, process characterization and aseptic fill and finish.

Quality from Constant Innovations

SPIRO Site, operating as the Research & Development Center, is located at Ziping Road in Shanghai International Medical Zone. The name SPIRO originates from the name of Ziping Road (Spirodela polyrhiza), a herb in Traditional Chinese Medicine. At SPIRO Site, we enhance our service capabilities through constant innovations in basic science, and provide customers with contract research services, process development, analytical development and extend services of gene and cell therapy products, including:

● Virology and Vectorology

● Cellular Biology

● Animal Studies

● Exocellular Vesicles

● Bioassay and Testing

● Process Development

● Analytical Method Development

● Novel AAV Capsid screening (AAVneO™ platform)

Capacity for Global

The current operating manufacturing footprint at OBiO covers of a pilot testing platform of +1,000 m², and a three-building cGMP manufacturing platform with +10,000 m² (107,639 ft²) in total. Furthermore, we have constructed OBiO Intelli-M site with 77,000 m² (828,821 ft²) 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.