Drug Substance (DS) Capabilities
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~ Bioprocess Development
Cell line Development
Developability Assessment
Process Development
Viral reduction steps and clearance studies
- Product Characterization: Mass Spectrometry, LC-MS (Glycan and product variants), MALDI-TOF, MS/MS (Ion-trap), CD, Fluorescence, SPR (Biacore), PAMAS (sub-vis), Solo VPE, Flowcam, Maurice (cIEF), HIAC
- Bioassays: Cell based, non-cell based, in vivo, proliferation, inhibition, reporter gene, effector function, secondary signaling
- Stability studies: Exploratory, freeze-thaw, real-time, accelerated and stress (forced degradation)
Clone Development
Demonstrated expertise with E. coli and Mammalian expression platform.
Single-cell clone selection based on high titer and quality attributes.
High throughput screening for clone selection using AMBR 15.
Cell line stability analyses.
Multiple storage location for cell lines
Upstream Process
Up to 0.01, 0.25, 5 to 200 L
Bioreactors
Cell Line Development
Process Development
Media Optimization
High throughput screening for clone selection for process development AMBR 15 & 250 ml
Single use platform
Process characterization
Pilot facility for GMP batches (ISO 8)
Bioreactors
Cell Line Development
Process Development
Media Optimization
High throughput screening for clone selection for process development AMBR 15 & 250 ml
Single use platform
Process characterization
Pilot facility for GMP batches (ISO 8)
Downstream Process
Process development and optimization
Scale: Upto pilot scale batches
Process characterization
GE Akta Chromatography Systems- Akta Pilot & Akta Pure
Pilot facility for GMP batches (ISO 7)
Scale: Upto pilot scale batches
Process characterization
GE Akta Chromatography Systems- Akta Pilot & Akta Pure
Pilot facility for GMP batches (ISO 7)
Drug Product (DP) Capabilities
Capability to convert drug substance to stable
formulations
Process characterization
Capable of filling all injectable forms
Stability studies on DS and DP as per ICH guidelines
