Skip to main contentSkip to navigationSkip to search

Development Services

At NXbio we have a proven track record of developing early-stage processes into manufacturing processes suitable for clinical applications and on to commercialization. We understand the need for different level of process performance and control through the pre-clinical and clinical development stages. We are experts within manufacturing technology utilizing microbial expression systems for production vaccines or other advanced therapies. Irrespectively if your product is a pDNA, a protein or any other biological we support you all the way. 

Development laboratory

Upstream Process Development

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 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 

Downstream Process Development

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 develop processes based on different modes of tangential flow filtration and chromatographic purification by all available modalities such as IEX, HIC, MM etc. to produce highly pure drug substance meeting your expected quality profile. 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
laboratory machine

Analytical Development

By defining the analytical package at an early stage, you ensure that the tools to characterize your product is at hand when you need them. This provides consistency from early development into late-stage clinical phases and gives you data that you and the regulatory bodies trust. 

Our development services encompass a fully aligned analytical development offering. As well as supporting your upstream and downstream development we can help you establish reliable analytical methods ready to be validated at our GMP QC lab.

We offer:

  • HPLC development
  • Sanger sequencing
  • Free solution Capillary Electrophoresis
  • qPCR/PCR for different applications
  • Protein characterization by various methods
  • Biochemical analysis
  • Stability testing

Our services