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cGMP Manufacturing

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.


Pre-IND service
Post-IND service
Pre-IND services
Non-IND (IIT) services
Non-IND (IIT) services
Manufacturing gene and cell therapy products in pilot testing scale that is compliant with cGMP management system, delivering quality inspection report and samples to facilitate non-IND clinical trials (IIT) initiated by investigators.
IND-CMC services
IND-CMC services
We provide IND-CMC services to support the IND/CTA application in China, America, Europe, and Australia. After process and analytical method development at laboratory-scale, we will carry out process scale-up test in cGMP production lines, implement the manufacturing, quality control and product release for a consecutive 3-4 batches, and provide you with a complete set of CMC dossier and samples required for IND application.
Pre-IND extended services
Pre-IND extended services
We provide a variety of Pre-IND extended services including bank construction for plasmid, cell or strain, aseptic fill and finish, stability studies, AAV capsid screening, sample testing, and quality control consultation.
Post-IND service
Clinical manufacturing service (for Phase I, II, III)
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
Commercial manufacturing
We provide commercial manufacturing services for marketed gene and cell therapy products at our OBiO Intelli-M site.
Post-IND extended services
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.
Capacity for Global

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.

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