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
More programs are developing integrated processes and using integrated analytical methods in manufacturing. This integration can also speed and benefit process development, even when the final manufacturing process is not integrated. Reports have been made of the use of PCC/SMB processes for capture and polishing. These integrate two or more similar columns operating in series and in parallel. Others have integrated capture steps like Protein A and subsequent polishing step after online pH treatment, like anion exchange chromatography. Some process analytical technologies use integrated spectroscopic methods like Raman, IR, or dielectric spectroscopy in bioreactors, as well as light scattering and full UV spectra in the downstream.
How can HTPD be used to develop integrated unit operations? Can these HTPD methods be used for process characterization? What types of analytical methods lend themselves to integration with HTPD methods?
This session will examine case studies using HTPD developing integrated unit operations and analytical methods.
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
The HTPD International Meeting allows conference attendees to walk out of their day-to-day concerns into a landscape of future possibilities where a deeper process understanding is possible using less time and resources. Likewise, the conference allows participants to meet scientists who have many overlapping interests and similar challenges.
This discussion will bring together panelists with a range of experiences and therapeutic goals to provide a snapshot of HTPD and Smart PD as applied to real situations. The panel discussion format means we can find out more about genuine problems, limitations and successes that the industry faces both in meeting targets today and in preparing for the future. Responses and topics can be practical, fanciful, political, and unpolished.
If you believe that you could add depth and breadth as a panelist, please submit (1) a short bio, (2) a description of your interest in participating in the panel, and (2) your contact information to the website by Sept 6th.
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.