Process Development

Having an inefficient biologic manufacturing process can obviously have significant consequences in later clinical and commercial stages.  Poor product quality and higher than expected costs can create havoc on a drug development program.  

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Recognizing that every biologic drug product is unique, Integrity Bio takes a customized approach when it comes to developing process development. During process development, we identify and optimize process conditions and parameters. The following are just some of the areas we concentrate on:

  • Ultrafiltration/diafiltration (UF/DF)
  • Product concentration
  • Sterile filtration
  • Buffer characterization
  • Aseptic fill/finish process development
  • Temperature sensitive formulations
  • Process scale up
  • Engineering runs