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PROCESS DEVELOPMENT

De-Risk Your Project

We have a fully equipped cell culture process development laboratory, a pilot plant for non-GMP toxicology batch sample preparation, and a pilot plant for GMP clinical sample preparation. We focus on cell culture process development, process scale-up, toxicology sample preparation, clinical sample preparation, process characterization, and process validation.

Scientist in a lab coat and mask using a pipette to handle liquid samples in a laboratory setting with test tubes nearby

Overview

Upstream Process Development

Diagram showing medium panel platforms, cell culture mode platforms with reactors, and development and manufacturing scales.

Our platform has supported process development for hundreds of molecules including monoclonal antibodies, bispecific antibodies, tri-specific antibodies, and fusion proteins - with up to 80% effective purification yields. It can support both batch production and continuous production process development techniques.

Our Offerings:

  • Design of experiments (DoE) 
  • Media/feed screening, process development/optimization using the Ambr 250 system 
  • Master/ working cell banking 
  • Perfusion process platform (Max. 6 g/L per day)
  • Fed-batch, Ultra-intensified Fed-batch Process (UI) and perfusion (15~35 g/L)
  • Qualification of scale-up and scale-down models 
  • Technology transfer 
  • Process characterization and validation studies 

Downstream Process Development

Our downstream process development platform offers state-of-the-art and high-efficient purification systems including affinity chromatography, ion exchange chromatography, hydrophobic chromatography, depth filtration, nanofiltration, and ultrafiltration. 

We offer advanced downstream purification systems such as ÄKTA pure, ÄKTA avant, ÄKTA pcc, Beckman Biomek i5 workstation, ÄKTA process, and ÄKTA ready for process development and pilot scale production. 

We have extensive purification process development experience with complex molecules.

Our Offerings:

  • Process characterization and validation studies 
  • Design of experiments (DoE) 
  • Process development, transfer and optimization 
  • Scale up from bench to commercial scale 
  • Qualification of scale-up and scale-down models  
  • High-throughput purification  
  • Viral clearance studies 

PROCESS CHARACTERIZATION & VALIDATION

Support for Your Product’s Commercialization

Our process characterization studies establish a commercial process control strategy and enable successful process performance qualification (PPQ), campaigns, and regulatory filings. Our workflows incorporate risk-based and knowledge-based quality by design (QbD) principles to systematically link process design and control to a product’s critical quality attributes (CQAs). 

Flowchart of four stages: Process Design, Technical Transfer, Process Qualification, Continued Process Verification.

Process Validation

We possess proprietary culture medium formulations, which can significantly reduce production costs and supply risks. Furthermore, we have a systematic approach to developing and optimizing culture medium formulations.

  • In vitro cell age study at scale 
  • Culture medium/buffer hold-time verification 
  • Reusable resin/ultrafiltration membrane life-time validation at scale 
  • Virus clearance validation 
  • Intermediate mixing study 
  • Repeated freeze-thaw study of production scale DS 
  • In process microbial monitoring 
  • Refiltration study

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