Process Development

At NorthX Biologics we have a proven track record of developing early-stage processes into a suitable manufacturing package for clinical applications and on to commercialization.

Every project requires a different approach when it comes to process development. We are ready to support you every step of the way.

Process Development

Process Development comes in many different forms.  We can work to create an entire process or help refine one you may already have.  Either way NorthX Biologics is ready to support.

By developing effective robust fermentation processes we ensure sustainable yields and processes that are scalable and compliant with regulatory expectations. By ensuring reproducible and controlled fermentation and harvest conditions, the amount of impurities progressed to downstream purification steps are minimized providing the basis for a high-quality final product. An effective upstream process ensures yields that supports your clinical trial and commercialization.

We offer:

  • Research, Working and Master Cell Banks
  • Clone selection
  • Process screening/optimization
  • Process verification in STR fermenters up to 15L (Single Use or glass)
  • Engineering runs up to 50L fermentation volume
  • Media screening
  • Harvest/Clarification development
  • Filter screening
  • Manufacturing of R&D grade material

We help you develop scalable effective downstream processes. By using the best available technology, we develop processes with optimized yields and high clearance of impurities. Our downstream capabilities are fully aligned with the upstream processes ensuring a seamless progression. We aim to set a purification process that is simple and robust encompassing the minimum number of unit operations ensuring economically feasible processes. 

We offer:

  • Resin screening
  • Buffer optimization
  • Chromatography development
  • Ultrafiltration/Diafiltration screening and optimization
  • Refolding development

Need a process developed? We are here to help.

Whether it is standalone or in-line with a manufacturing project, NorthX Biologics can support your process needs from start to finish.  We ensure phase appropriate development and allow for scalable solutions.

Let’s journey together

NorthX Biologics is dedicated to the journey of complex biologics. Let us know how we can help move your product forward.