Process Development

Process Development

Partner with us for access to state-of-the art equipment, experienced teams, robust workflows and bioinformatics.   

Our downstream process expertise can develop high yielding processes that are supported by our comprehensive in-house analytical capabilities and biophysical methods.  

Our in-house software application ORBIT (Optimized Resource for Biologics Information and Toolkits) and the use of MOE (Molecular Operating Environment) add value to the development of protein–based biologics, giving insight into their manufacturability.  When applied to molecules of interest, critical quality attributes and isoelectric points are predicted to assist manufacturability assessments.  This information aids purification decision making, shortening the process development timelines and facilitates creation of a more robust manufacturing process.  

Process development and optimization is performed using glass and stainless steel vessels at scales ranging 15 – 100L prior to further process scale up. High through-put process scouting and process characterization can be performed using ambr250® microbioreactor systems. Our experience includes working with secreted, periplasmic and insoluble (inclusion bodies) proteins and protein refolding.

Our fermentation expertise encompasses:

• Proven platform processes
• Transfer and development of client clinical and commercial processes
• Optimization of fermentation conditions, media and feeds
• Full development and optimization of primary recovery stages including flocculation and inclusion body recovery.

Down-stream purification ranges from scale up assessments to full process development.  Our modular workflows, high throughput capabilities and standardised approaches to unit operation development ensure that your process achieves the maximum yield and product quality possible.  We work with you to develop a scalable process before transfer into cGMP manufacturing facilities.  

Our downstream purification offering includes:  

• Filtration development  
• High throughput refolding development and optimization  
• High throughput resin screening and chromatography development  
• Tangential flow filtration and formulation development  
• Process Intermediate stability assessment  
• PEGylation/Conjugation Development and Optimization  
• Product quality assessment  
• Process Characterization  

Activities leading to commercialization are supported by the Process Development team and in-house statisticians, these include:  

• Generating and qualifying scale down-models  
• CQA identification and FMEA  
• Analytical method qualification and pre-validation activities  
• Scale down model verification  
• Process Characterization studies   
• Intermediate and media stability studies  
• Resin and membrane lifetime studies  
• Robustness and/ or linkage studies  
• Unit operation screening and/or DoE 

Contact us to learn more about our microbial capabilities.