Discovery

Development

Testing

Clinical Manufacture

Commercial Manufacture

Drug Product Fill & Finish

Antibody Drug Conjugates

Technologies & Platforms

We offer state-of-the-art cell culture development labs and a non-GMP pilot plant occupying 23,500 sq. ft. of lab space supported by a staff of over 130 dedicated and skillfully trained scientists.  Our cell culture process technology platform provides for clone screening & selection, optimization of media, seeding densities, feeding and bioreactor process control strategies to maximize expression, enhance process reproducibility and facilitate scale-up. Throughout any development process, quality by design (QbD) concepts are utilized. The upstream development labs are equipped with a wide variety of cell culture production systems as well as many advanced in-process testing technologies that include:

  • Over 260 bioreactors ranging from 1L to 2,000L
  • GMP & Non-GMP manufacturing at 50L, 100L, 200L, 500L, 1000L, 2,000L  
  • ATF™-based perfusion platform (ATF 2, ATF 4, ATF 6, and ATF 10) up to 1,000 L
  • Wave- and rocker-based Bioreactors
  • Ambr™ system (Ambr 15 and Ambr 250)
  • Cell Culture Analyzers
    •    Vi-cell, multiple microscopes
    •    Novaflex, Bioprofile 400, YSI, Cedex Bio HT
    •    BGA, Osmometer, Sterile tubing welder and sealer, Terumo tubing welder
    •    Integrity tester
    •    Media prep systems for lab & pilot plant

We provide the capacity to conduct more than 30 simultaneous development projects at various development stages. Our development team and wide variety of technology platforms offer maximum flexibility as to when and where in the development stage a project can be initiated. Depending on the nature of a project, our upstream development team supports:

Standalone projects
  • Media screening, media adaptation etc
  • Material generation in various scale bioreactors at different stages of projects, including transient & pool material production
  • Process optimization for productivity and/or product quality improvements
IND-enabling cell culture activities
  • Clone selection, process optimization, scale-up & tox material production
  • Tech transfer to Wuxi facilities for cGMP production for worldwide IND application submissions
Late stage cell culture process development
  • Tech transfer
  • Commercial process development, process characterization and validation
ATF™-based perfusion and concentrated fed-batch platform
  • High viable cell density (40 – 60 × 106 cells/mL) and viability (>90% for perfusion)
  • For perfusion: long term steady-state operation (typically 40-80 days) and stable productivity and product quality across the run
  • For concentrated fed-batch: quick adoption from fed-batch with >5× harvest product titer and improved product quality
  • From bench top scale-down model (2-10L with ATF2) to cGMP manufacturing production (up to 1,000L disposable bioreactor with ATF10)


Product Quality Optimization

Product quality optimization is an essential part of bioprocess development. We have developed a comprehensive set of toolboxes for the optimization of various product quality attributes,with the examples shown below.

  • Aggregation control
  • Charge variant control
  • Glycosylation optimization to increase or reduce G0F or other glycan species
  • Sialic acid content optimization
  • ADCC/CDC activity optimization
Product Quality Optimization Case Studies:

Glycan profile optimization to reduce G0F

ADCC optimization

CEX improvement via DoE

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