Downstream process development for monoclonal antibodies (mAbs) has become an exercise in efficiency due to the desire to be fast-to-clinic. Many companies have resorted to using a purification platform to decrease timelines. With the onset of high-throughput process development, development timelines and material requirements could be further decreased. Here, we demonstrate the synergy of utilizing high-throughput development with an existing downstream platform to enable mAb drug candidates to be brought to clinical trials faster. Using pre-determined and antibody-compatible parameters, a lean phase 1 downstream process was developed. Final conditions were determined based on maximum process yield and aggregate clearance. This study also served to show the comparability between microliter-scale (Tecan with RoboColumns®) and milliliter-scale (AKTA® with small-scale columns) development.
Justin Crisafulli is currently a Downstream Process Development Scientist at Biogen. Prior to joining Biogen, Justin participated in three process development co-ops at Genzyme, Baxalta, and Momenta While at Northeastern, Justin completed a Bachelor of Science degree in biochemistry as well as three process development co-ops at Genzyme, Baxalta, and Momenta. While at Momenta, he had the opportunity to develop methods on the Tecan Evo system using OPUS®Robocolumns®. This has transferred well in Justin’s transition to Biogen where he is the high throughput process development lead. At Biogen, Justin contributes to the development of monoclonal antibodies and other recombinant proteins. Justin holds a Bachelor of Science degree in Biochemistry from Northeastern University.