Sessions and chairmen

1. Smart Process Development
     Jürgen Hubbuch, KIT, Germany

 

4. Case studies Downstream
    Part II: Other techniques 
       Ashley Hesslein, Bayer
       HealthCare, USA

2. Case studies Upstream
     Jonathan Coffman, Boehringer
     Ingelheim, USA

 

5. Case studies DS modifications and
    DP Formulations
       Aaron Noyes, Codiak
       BioSciences, USA

3. Case studies Downstream
    Part I: Chromatography 
     Jennifer Pollard, Merck, USA

 

6. Frontiers in Process Development
       Stefan Hepbildikler, Roche,
       Germany

 

 

  1. Smart Process Development – Smart PD

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? Today, data gathered is mostly used to confirm our thinking, while a large part of the information is unused and discarded unseen. Data mining in large data sets (as done every day by the internet giants) is hardly applied yet. Are we thus smart in how we are using our resources? HTPD as we know it today will in future become merely a stepping stone towards in-silico process development (or not?). Are we ready yet? In this session, we discuss the use, limits and potentials of models and data mining approaches (e.g. MVDA, QSAR, DoE, Mechanistic Model) helping us to direct, focus, reduce or eliminate our screening efforts.

 

  1. Case studies Upstream

Upstream high throughput development has been revolutionized in the past few years. Turnkey solutions to mammalian and microbial cell culture development have been developed and sold commercially. Even so, these solutions are not “out of the box” scale-down models of large-scale bioreactors or fermenters. This session invites speakers to describe differences between these instruments and at-scale bioreactors/fermenters. Case studies of where these systems are used will be welcomed, such as clone screening, media development, or formal process characterization studies.

We are also interested in a fundamental understanding of the scale-related differences, for instance the use of CFD models.  The use of HTPD methods for perfusion processes would also be considered.  Other topics include linking upstream and downstream HTPD, and HTS sample prep for high throughput analytics.

 

  1. Case studies Downstream Part I: Chromatography – Now what?

Chromatography high throughput process development is a mature field, with slurry plate methods and miniaturized columns as well established techniques which have been demonstrated in multiple case studies for use in early and late stage process development.  This session would like to explore where we go from here.  How far can we push HTPD, in terms of material and time?  How do we go from using HTPD for supplementary data to primary data and what are the gaps/limitations to relying on high throughput?  How can we apply it in the manufacturing space and how do we account for scale differences?  Areas of interest would be on scale down model qualification for miniaturized columns, or utilization of high throughput techniques for process characterization and column linkage studies, troubleshooting and deviation resolution, and assessment of raw material variability.  We are also interested in how these techniques can be applied in other areas of process development, such as the development of mechanistic models, continuous processing, high capacity formats/membranes, and other modes of chromatography. 

 

  1. Case studies Downstream Part II: Other techniques

Column chromatography remains the most frequent unit operation for downstream purification, and is often the first choice for industrial protein purification processes. However, alternatives for traditional column chromatography are in use. This session will capture separation processes for protein purification, and unconventional chromatography processes.

Additionally, this session will entertain examples of pushing downstream processes to the minimum size or material amounts, cross-functional partnering (i.e. linkage studies, screening of clone selection), and process characterization using HTS methods.

 

  1. Case studies Drug Substance and Drug Product Formulations

Advances in biotechnology and molecular biology have unleashed a wave of highly engineered constructs ranging from the modification of drug substances, i.e. pegylation, conjugations, enzymatic cleavage, conversion between dosage forms, etc. to the introduction of novel therapeutic modalities, including large macromolecular complexes such as vaccines, viral vectors, and liposomes.  Gaining insight into interactions, kinetics, conformation, and stability is challenging, often leading to limited understanding.  The development of process and formulations for these constructs presents an opportunity for HTPD yet also a challenge to integrate high throughput assays that can provide relevant information with sufficient resolution.  In this session, we are seeking examples where HTPD has informed process and formulations choices for drug products and complex drug substances.  Where has HTPD been particularly useful? Has HTPD provided fundamental understanding of molecular stability?  What challenges have been encountered and which remain to be tackled? 

 

  1. Frontiers in Process Development

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. However, our industry is facing new challenges related to new molecule formats, novel formulations and accelerated development programs. In addition, a rebirth of non-standard technologies and modes of operation also puts future product development programs in focus.

To look at game-changing opportunities in bioprocessing, this session invites speakers to present the latest trends and concepts in process development beyond HTPD. Contributions focusing on innovative approaches to develop and characterize new unit operations, future modes of operation, i.e. batch vs. continuous, use of mechanistic modelling, and any other novel approaches are enthusiastically welcomed.