Although several high-throughput methods are routinely used for process development there are still many challenges to address. Examples include potential analytical bottlenecks, effects of scale and formats on data, interpretation of data, and adequate control of experimental conditions at the microscale. Analytical bottlenecks here relate to the limited number of quick methods for the determination of critical quality attributes, especially for biomolecules that are not monoclonal antibodies, and/or to challenges associated with assessing drug product stability. Both the scale of HTPD experiments and the formats used can affect results.
Furthermore, the subsequent interpretation of the data is still an area of debate, especially with respect to applicability of high-throughput data for scaling-up purposes. The lack of control of experimental conditions where times are long, such as those typically performed in during upstream process development, or the lack of control over the mixing and flow regimes for different formats used may have a profound effect on results. Obviously, these and other challenges warrant both experimental and theoretical considerations, and addressing them will help advance the area of high-throughput process development further.
The goal of this conference is to provide a leading forum for discussion of the challenges and benefits of high-throughput techniques in the development of production processes and stable formulation for biological products.
Sponsored by GE Healthcare, with the active involvement of industry experts, the HTPD conference series provides an excellent opportunity to discuss and influence the future of high-throughput process development methods in our industry.
Following the success of the first conference in 2010, we are delighted to announce the Second International Conference on HTPD in Avignon, France. This Second conference will have an expanded scope covering process development from upstream processing, through downstream processing, to stable formulation.