~ 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)
Formulation Screening & Development

Drug Substance (DS) Capabilities

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
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)

Drug Product (DP) Capabilities

Capability to convert drug substance to stable

Process characterization
Capable of filling all injectable forms
Stability studies on DS and DP as per ICH guidelines

World Class Quality & Accuracy
by Professional Experts