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June 07, 2018

Future of process development: modeling and miniaturization

By Mats Gruvegård, Downstream Marketing manager

The main topics of the latest high-throughput process development conference were mechanistic modeling and miniaturization. The extended report captures 15 of the presentations. Here’s a summary.

Fourth HTPD conference in Toledo, Spain, October 2017

The HTPD conference series started as a joint initiative of GE Healthcare and Genentech in 2010, at a time when high-throughput process development (HTPD) was in the early days and mainly limited to 96-well plates for resin selection and initial screening of chromatography running condition.

Since then, HTPD has been well established in downstream chromatography applications among most biopharmaceutical companies, and has expanded to upstream cell culture medium screenings as well as to formulation applications.

Several talks focused on the use of miniaturized columns and screening plates, such as PreDictor 96-well plates and PreDictor RoboColumn™ units, and the possibility of these formats to become even more important tools going forward.

Some insights from latest meeting

Tobias Hahn and Thiemo Huuk, both from GoSilico, discussed different aspects of mechanistic modeling, batch isotherms, and the scalability of models. Michael Chinn from Genentech talked about the importance of understanding scale offsets to be able to use miniaturized formats as scale-down models.

Carsten Musmann, Roche Diagnostics, shared his experience in parallelization and automation to maximize efficiency in development of upstream processes. Cornelia Walther, Boehringer-Ingelheim, presented integrated process development and miniaturized formats to improve early process understanding.

Peter Hagwall, GE Healthcare discussed resin variability and impact on process performance and product quality. David Smithson, Genentech addressed formulation challenges and approaches to increase overall throughput while minimizing sample consumption.

Continuous improvements in process development

These were just a few of the presentations included in the extended report.

Since the very first meeting in 2010, the goal of the HTPD conference has been to provide a leading forum for discussion and exchange of ideas around challenges and benefits of employing high-throughput techniques in the development of biomanufacturing processes.

Today, novel technologies and approaches, such as in silico modeling, are included in the scope. Continuous improvements, information sharing, and novel strategies are prerequisites for the biopharmaceutical industry to keep up with the ever-increasing demands on speed, quality, and throughput.

Where will we go next?

The planning for the next HTPD conference has already started. According to feedback from the Toledo conference, two topics were highly requested: high-throughput analytics and data management/mining. Stay tuned for more information.

Until then, you can download the extended report here.