1. Smart Process Development - Smart PD
Jürgen Hubbuch, KIT, Germany
HTPD allows us to harvest a sea full of data. But do we see the information given to us or do we only get what we screen for in order to confirm what we expected anyway?
In the era of digitalization and artificial intelligence, is HTPD as we know it today merely a stepping-stone towards in-silico process development? Is it a synergy of HTE, modelling, process data etc. that leads us to a smarter PD? In this session, we discuss the use, limits and potentials of in-silico models, soft sensors and data mining approaches (e.g. MVDA, QSAR, Mechanistic Model, AI) helping us to direct, focus, reduce or eliminate our screening efforts
2. Case studies Integrated PD and analytics
Jonathan Coffman, Boehringer Ingelheim, USA
3. Case studies - Monoclonal antibodies and antibody-like molecules John Welsh, Merck & Co, USA
While platform approaches for monoclonal antibody (mAb) processing have become commonplace, the number of antibody-derived proteins continues to expand. These include domain antibodies, bi-specifics, Fab and Fc fragments, antibody drug conjugates, fusion proteins, and a host of other related molecules. This session is seeking case studies in two areas: i) novel approaches to platform mAb processing implementing HTPD and ii) HTPD and smart process development approaches for processing of unique mAb-like structures. These approaches are not limited to standard bioprocessing unit operations and may include strategies across all areas of bioprocess development (cell line, upstream, downstream, analytical, and formulation).
4. Case studies - Novel biomolecules
Jack Kramarczyk, Moderna Therapeutics, USA
Development of emerging therapies has challenged the industry to invent and design novel therapeutic modalities and product definitions. Cell, gene, and nucleic acid therapies each have unique production, analytical, and drug delivery challenges. Complex delivery vehicles such as whole cells, cell derivatives, viral vectors, liposomes, nanoparticles, or emulsions, are often required for new therapeutics. This session is seeking case studies of high-throughput process development for novel therapeutic modalities and delivery vehicles. The high-throughput process development work presented may include standard bioprocessing unit operations, analytical development, and formulations. In addition, the session will focus on HTPD work involving novel unit operations and novel miniaturizations designed to address the specific challenges of developing an innovative modality.
5. HTPD/Smart PD panel discussion
Ashley Hesslein, Bayer HealthCare, USA
6. Frontiers in HTPD/Smart PD
Stefan Hepbildikler, Roche, Germany
High-throughput process development (HTPD) has been successfully applied in many academic and industrial labs for more than a decade. It has proven its value in all areas of process development from upstream to downstream to formulation. At the same time, new our industry faces new challenges and potential applications, such as new therapeutic modalities, novel formulations, connected and continuous processing, and accelerated development programs.
To look at game-changing opportunities in bioprocessing, this session invites speakers to present the latest trends and concepts in HTPD and smart process development. Contributions addressing innovative approaches to develop and characterize new unit operations, connected and continuous mode of operation, and to support health authority submissions by HTPD and smart PD as well as any other novel approaches are enthusiastically welcomed.