USP and DSP teams work hand-in-hand to speed up process development and make every project a success.
We routinely deal with a variety of expression systems. Our special strengths include protein refolding expertise that has been finely honed by years of project experience.
We can adjust and fine-tune the steps of downstream process development to meet your needs. This includes complete DSP development from scratch and/or DSP adaptation and optimization studies. Our general downstream process development services can include:
At Richter-Helm BioLogics, a large arsenal of cutting-edge purification techniques is available for DSP development for large-scale biomanufacturing. The use of small-scale equipment facilitates the development and optimization of downstream processes based on:
In a multistep approach (with capture, intermediate purification, and polishing), we can use state-of-the-art chromatography techniques (in FPLC or HPLC mode) including:
All of these development tools can be used to identify the best fully scalable downstream process design for efficiently purifying your product.
In addition to QC testing, rapid at-line PD analytical tools can be employed at any point of the development phase. These include:
Design of experiment (DoE) tools (applying full or fractional factorial design modules) are routinely used to assist in developing and optimizing processes or, if applicable, to supplement parameter screenings etc.