Process Development

After knowledge transfer of the existing process, our team employs a Quality-by-Design product strategy to advance and scale up the process to one that is robust, phase-appropriate, and commercially viable.  

We can work with you to develop the various component processes required to produce your novel therapeutic product, such as cell banking, vector production, upstream/downstream processing, formulation, fill and finish, analytical testing, and product/process characterization..  

Our analytical development team provides comprehensive custom assay development services to ensure effective product and process characterization. We also have pre-established standard assays available to fast-track your method development..  

Our proprietary production platforms for cell & gene therapy technologies can serve as a launching pad for developing an efficient and scalable manufacturing process for your novel therapeutic.

Our upstream process development facility is equipped with production systems across the range of scales and modalities to facilitate optimization and scale-up of your upstream processes. The lab is outfitted with adherent and suspension bioreactor systems that cover a range from 10mL to 50L and can support fed-batch and perfusion processes..  

We have established downstream systems and workflows that can accelerate the characterization of our clients’ processes and products. Our process development and analytical method development groups work closely every step of the way to ensure early and proper identification of your product’s quality attributes and critical process parameters. Our team possesses the expertise to optimize downstream purification of your novel drug product. We work closely with you to establish a custom purification scheme that is optimized for quality and yield based on the unique characteristics of the target product.