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Upstream Process Development

We offer state-of-the-art cell culture development labs and a non-GMP pilot plant specializing in the process development, characterization and validation and process scale-up for successful cGMP clinical and commercial manufacturing We provide extensive experience in traditional fed-batch, continuous and/or intensified processes to support all stages of drug development from pre-clinical to commercial production.

 



Occupying over 47,000 sq. ft of building space and expanding over the next several years, our upstream development labs are equipped with a wide variety of cell culture production systems and analytical tools such as 1L to 15L traditional glass bioreactors, perfusion systems to support intensified and/or continuous processes, high throughput AMBRTM systems (AMBR15 and AMBR250), Finesse and Applikon Controllers with Delta V systems, Wave bioreactors, and Cedex Bio HT high throughput bio-analyzers.

 



  • Clone selection, process optimization, scale-up and toxicology material production
  • Technical transfer to GMP production teams
  • Technical transfer
  • Commercial process development
  • Process characterization and validation
  • IND and BLA CMC dossier support
  • Media screening and adaptation
  • Material generation at various scales of production
  • Process or unit step development and optimization – including harvest steps

Although we have developed hundreds of processes using our WuXiaTM cell line and well-vetted cell culture platform, multiple processes have successfully been developed, scaled and transferred to GMP manufacturing using cell lines and processes developed by third parties or by our clients. Our team is highly experienced in the technology transfer of processes into our labs as well as the transfer of processes to our GMP manufacturing teams across a wide-range of molecule types.

 


With over 300 dedicated and skillfully trained scientists, we provide the capacity to support more than 50 programs simultaneously at various development stages. Over 100 projects have been successfully delivered to global IND since 2015 with a 100% approval rate.

 

 

Product Quality Optimization

Product quality optimization is an essential part of bioprocess development. We have developed a comprehensive toolbox for the optimization of various product quality attributes, that include:

 

  • Aggregation control
  • Charge variant control
  • Glycosylation optimization
  • Sialic acid content optimization
  • ADCC and CDC activity optimization