Drug Substance Manufacturing
Leveraging systems with single-use components and flow paths ensures regulatory compliance, cGMP compliance and greater operational flexibility, allowing us to provide cost competitive proposition for your biologics’ clinical or commercial supplies. Our MSAT team collaborates with process development and manufacturing teams to identify Critical Process Parameters (CPPs) and Key Process Parameters (KPPs) through risk assessment using tools such as, FMEA. We also develop and qualify appropriate scale-down models to be used for process characterization studies and finally define an appropriate control strategy for the identified CPPs and KPPs.
With 48,000L for capacities for mammalian and multiple modalities, we feature amongst the leading CDMO capacities in the Asia-Pacific region (APAC).
Mammalian
Comprehensive pre-clinical through commercial manufacturing using mammalian systems
Our large single use bioreactor (SUBs) capacities are suitable to execute cell culture processes with end-to-end disposable systems for better regulatory compliance, no product carryover, efficient turnaround time between batches and operational efficiencies.
Key Highlights
- Flexible infrastructure to accommodate monoclonal antibodies and fusion proteins
- Cell banking of Master Cell Banks (MCBs) and Working Cell Banks (WCBs)
- Single-use bioreactor train
- Harvest clarification and filtration systems
- Chromatography systems and columns
- Virus filtration capacity
- Ultrafiltration and diafiltration capabilities
- Commercial manufacturing capacity up to 2000L per batch
Microbial
We use a hybrid model with stainless steel fermenter for upstream, single-use and conventional systems for downstream processing and designed for process scale-up studies at microbial 50L and mammalian 200L scale.
Key Highlights
- Expertise in handling various microbial expression platforms
- Microbial scale-up train design from 50L to 300L to 1000L
- Cell lysis capabilities using high pressure homogenization or chemical lysis
- IB solubilization and refolding capabilities
- Chromatography systems to handle various chromatography types, including reversed phase process chromatography
- Columns to suit aqueous and reversed phase chromatography applications
- Ultrafiltration and diafiltration facility
- Lyophilization capabilities for Drug Substance
Other modalities
- Robust approach for developing scale-down models, process characterization and defining the control stages for scale-up
- Single use technology, providing optimum flexibility and cost-effectiveness for any volume demand
- Scale-up train design from 50L to 200L to 2000L
- Industry-leading expertise in process development and high-throughput analytical development
