Mammalian and cell therapy manufacturing: clinical to commercial
In the last few years, significant pharmaceutical industry presence has developed in the Tuas Biomedical Park, led by our initial trailblazing investment in 2005. As a leader in global custom manufacturing, we have expanded our presence in these growing Asian demographics. Our Singapore site is part of our worldwide custom manufacturing network and provides customers with capacity to successfully develop and commercialize their products in the global market.
Our Tuas site is a facility designated for the contract development and production of monoclonal antibodies (mAbs) recombinant / fusion proteins and allogeneic cell therapy products. Our multi-product facility is located on an industrial estate in western Singapore. We commenced cGMP production in early 2011 with bioreactor systems at 20,000L (stainless steel) scale and subsequently in 2018 at 2,000L (single-use) scale, for both clinical and commercial operations. The site provides development services for both early phase clinical (cell line construction and process developments) as well as late phase clinical (process characterization/ validation and BLA services). In addition, the site is the center of excellence for allogeneic cell therapy.
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Large-scale (20,000 L) and small-scale (2,000 L) GMP mammalian manufacturing services
- 20,000L production bioreactor suites
- Inoculum laboratories
- Seed bioreactor trains
- Supplementary feed tanks
- Primary recovery system comprising centrifuge, depth and terminal filters
- Four purification suites
- Large scale chromatography columns, between 1.0m and 2.0m
- Tangential flow filtration systems
- Bulk fill suites: final filling into bottles, bags or cryovessels
- Bulk product storage temperature ranging from 2-8°C to -80°C
- 2,000L production bioreactor suites
- Single-use seed bioreactor trains
- Primary recovery by depth filtration system
- Pre and post viral purification suites
- Small-scale chromatography systems
- Column sizes ranging from 14 to 60cm
- UF/DF and other filtration systems
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Development services for mammalian products
- Cell culture development services
- Cell line development
- Upstream process development
- Customer process transfers
- Cell bank creation and characterization
- Purification development services
- Platform purification process
- Customer process transfers
- Downstream process development
- Viral clearance studies
- Analytical services
- Method transfer
- Stability testing
- Process characterization
- Protein characterization
GMP allogeneic cell therapy product manufacturing services
- Dedicated allogeneic cell therapy suites
- Clinical and commercial manufacturing
- Dedicated cell therapy media formulation and fill suite
- Additional space available for expansion
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Quality systems and regulatory inspections
We operate local quality management systems that comply with internal policies as well as with national and international standards and regulations (e.g. GMP, PIC/S)
- United States Food and Drug Administration (US FDA) Code of Federal Regulations (CFR) Title 21, Parts: 11, 210, 211 and 600 (where applicable)
- Eudralex - Volume 4 Good Manufacturing Practice (GMP) Guidelines
- International Council for Harmonization (ICH)
We are proud of our excellent track record of over 20 successful inspections from various agencies over the past seven year without any critical observations.