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).
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.
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.