Session 1: Upstream - Lessons Learned and Future Challenges
Session chair: Jonathan Coffman, Pfizer, USA
Downstream process development has seen a renaissance in the use of high-throughput process development (HTPD). Upstream development has had significant success in the effort to adapt microbial or animal cell culture to a high-throughput format, but it has also had, sometimes expensive, failures. What lessons have been learned from these? What do they mean for the future of HTPD for microbial and animal cell culture? We would like one or two speakers to discuss “failures” they have experienced, and one or two speakers to discuss successes.
HTPD in any of the following areas will be welcomed:

	Initial clone selection or adaptation
	Optimal bioreactor or fermentation conditions
	Media development
	QbD/design space determination, including a discussion on the applicability to scale up
	Linking HTPD culture or fermentation to analytical instruments
	Other areas

Session 2: Downstream - Lessons Learned and Future Challenges
Session Chair: Jens H. Vogel, Bayer Healthcare, USA
Miniaturization, parallelization and automation of bioseparation experiments is at the heart of HTPD approaches in downstream process development and characterization. As a result, many companies are now using techniques such as batch adsorption and mini-column experiments, typically on standard robotic workstations. However, questions remain, e.g. with regards to analytical bottlenecks, applicability to relevant scales etc., that limit the potential. This session seeks to discuss the actual efficiencies gained and the practical and fundamental challenges and limitations encountered applying HTPD techniques for downstream development, and how those may be overcome to move the development to the next level.

Session 3: Formulation - Lessons Learned and Future Challenges
Session chair: Andrew Kosky, Genentech, USA
Robotic liquid handling systems enable formulation scientists to rapidly prepare an enormous variety of formulations and to subject these samples to a variety of stresses such as temperature, shaking, and light energy. In this session we are seeking presentations that describe practical aspects of this technology such as the scalability of results, preventing contamination of samples held for long periods of time under stressed conditions, as well as to explore how the introduction of robotics has changed the way in which formulation scientists think about the design and execution of their experiments. We are also seeking case studies that demonstrate how robotics have impacted fundamental knowledge of protein and vaccine stability.

Session 4: Data Analysis and Managing Large Datasets – Challenges and Opportunities
Session chair: Prof Nigel Titchener-Hooker, University College London, UK
As the need to prove that complex and frequently highly interacting systems are well characterised and ultimately predictable when scaled to manufacture, has grown so has the need for the application of more advanced data analysis tools and the capacity to handle increasingly large data sets. In this session we welcome papers which explore approaches for the analysis and understanding of complex datasets obtained with High Throughput experimentation techniques. We are looking too for case studies exploring techniques used in the handling and interpretation of large datasets. The session aims to assess the very latest advances in the field and, by way of real industrial application, to understand better the potential barriers to adoption and the progress being made.

Session 5: Quality by Design - An HTPD Perspective
Session Chair: Stefan Hepbildikler, Roche, Germany
Since implementation of the ICH Q8 guideline the first QbD filings have been submitted to the health authorities. Theoretically, high throughput experimentation is a powerful tool to support QbD elements such as process characterization and validation. In addition, HTPD can facilitate linkage of steps studies and process models. This session invites process development professionals from upstream, downstream, formulation and analytics to present HTPD applications in the QbD context and to discuss the requirements for including HTPD data in state-of-the-art QbD filings.

Session 6: Case Studies - HTPD in Action
Session Chair: Thomas Linden, Merck, USA
With more and more pressure on development timelines for biopharmaceutical molecules and the need to increase process knowledge, early HTPD techniques together with appropriate analytical tools have become an important part of today's process development strategies. With smart design of experiments, upstream, downstream process and formulation development can truly benefit from HTPD experimentation throughout all phases of development from an early developability assessment through media, resin/filter and operating parameter screening up to detailed process characterization. But is it always useful? In this session we are looking for a detailed discussion of "real life" examples, case studies where miniaturization and HTPD experimentation informed or actually misinformed development activities.

Poster Session
Contributions related to all aspects of high-throughput process development including, but not limited to, new formats, new automation principles, further miniaturization, theoretical and practical considerations, etc. are welcome.