Process Development

Our process development services are designed to offer efficient bioprocesses and scale production of recombinant proteins to meet your development goals.

Our services include:

Cell Culture (Upstream) Process Development:

• Screening commercial media and basal media supplements (click for data slide)
• Initial bioreactor process development

Purification (Downstream) Process Development:

• Initial optimization of cell harvest and cell removal process
• Concentration and diafiltration using tangential flow systems
• Development of purification process (ion-exchange, HIC, size exclusion and affinity chromatography) to meet the client’s final product specifications
• Protein characterization via multiple analytical means
• Development of final product specifications

Analytical Services:

• Analytical method development of in-process and final product testing
• HPLC, ELISA, Western blot, SDS PAGE, IEF
• Binding assesment via Forte Bio Octet system 

Stability Studies:

• Evaluate short term, accelerated, and long term stability of the product
• Testing can include various analytic and functional assays
• Formulation/excipient evaluation