Process development

PX'Therapeutics has recognised experience in the development of robust and scalable production processes. Each project is developed with the aim of allowing a seamless transfer to higher-scale manufacturing (non-GMP or GMP), taking into consideration customers’ specifications, and regulatory and operating constraints.

 

Our objective: to develop economic processes combining high productivity, purity, safety and quality.

 

 

Microbial process development (E.coli, yeasts):

 

High productivity

  • Fermentation in batch or fed-batch mode

 

High purity and safety

  • Harvest of supernatant by centrifugation or microfiltration or cell lysis by high-pressure homogenisation

  • Clarification by centrifugation, microfiltration, depth filtration and membrane filtration

  • Advanced preparation of inclusion bodies and refolding processes

  • Purification by chromatography (ion exchange, hydrophobic interaction, mixed-mode, affinity)

  • Concentration and pre-formulation by tangential flow filtration

  • Bioburden reduction

 

 

Mammalian process development:

 

High productivity

  • Bioreactor in batch or fed-batch mode for suspension cells

  • Hyperstacks or cellstacks for adherent cells

 

High purity and safety

  • Clarification by depth filtration or centrifugation

  • Purification by chromatography (affinity, ion exchange, hydrophobic interaction, mixed-mode)

  • Concentration and pre-formulation by tangential flow filtration

  • Virus inactivation and removal

  • Bioburden reduction

 

 

Quality-control development:

 

High quality

  • Close relationship with the analytic/QC team to develop analytical methods, monitor process development and perform stability studies.