Sessions and chairs 2023

  1. Smart Process Development - Modeling
        Jürgen Hubbuch, KIT, Germany / Tobias Hahn, Cytiva, Germany

Smart PD: knowledge is power! With HTPD, model-based process development, and advanced process analytical technologies, we can not only become faster, but also evaluate more process scenarios than ever before and thus gain a deeper understanding of the process dynamics. The employed models are divided into white-box, grey-box and black-box models. White-box models in particular allow us to explain cause and effect, but also machine learning approaches allow us to develop new hypotheses. In this session we will discuss how knowledge can be generated with smart PD methods, how digital twins can be implemented in real-world scenarios and how the cost-benefit ratio can be optimized to work smarter and cheaper at the same time.

  1. Evolution of Mature HTPD Platforms
      John Welsh, Merck & Co, US / Brian Murray, Sanofi, US

Over a decade after this conference’s first meeting, this session will focus on the evolution and current status of mature high throughput process development platforms. Specifically, this session will highlight: (i) the development of HT technologies to enable mature HTPD platforms and (ii) applications of these platforms. For enabling mature platforms, examples involving technology development (e.g. software, hardware, automation) or overcoming challenges to facilitate implementation across diverse modalities are encouraged. For applications of mature HTPD platforms, case studies from later stages of process development such as bioprocess control strategy development using high throughput tools or lessons from regulatory interactions around HTPD are welcome. Lastly, this session is interested in the development of novel data applications for bioprocess development that are enabled by having a mature HTPD platform (e.g. digital workflows).

  1. Integrated PD and Analytics Case Studies  
      Jon Coffman, Astra Zeneca, US  / Andrea Rayat UCL, UK

Analytics have always been a significant bottleneck for HTPD implementation. The number, volume, and format of the samples often prevent a full analysis of the results. We are interested in case-studies for integrating HTPD and analytical methods. We are interested in methods that can be used in control loops during the HTPD, especially those that control PQ or CPPs in a dynamic manner. In these cases, demonstration of a control loop would make an ideal presentation. Multi-attribute methods applied to HTPD without control loops is also challenging and valuable. In-line/on-line/at-line analytical methods for extremely small volumes, such as those found in microfluidics, are also limiting HTPD. Since, many HTPD methods remain a curiosity, we want to see how they are actually being used to develop manufacturing processes. Case studies using these methods in a routine development business process would be highly relevant. A discussion of factors (e.g., technological, business, human factors, etc) preventing the routine use of HTPD would be appreciated.

  1. Calling All Nanoparticles: HTPD with Cells, Viral Vectors, LNPs, Gene Editors, and Vaccines
      Jack Kramarczyk, Moderna Therapeutics, USA / tba

Developing dispersions and suspensions of nanoparticles as pharmaceutical products can bring significant challenges, relative to development of soluble products of uniform composition.  Nanoparticles are inherently challenging due to their large size, unique behavior, and variability across the population.   These complex delivery vehicles and active pharmaceutical agents may require unique unit operations and analytical methods; additionally, the laboratory systems and experimental methodologies used for process design and characterization may require inventive solutions and novel approaches. 

This session will review case studies which highlight approaches, strategies, gaps, and opportunities for miniaturization and HTPD designed to address the specific challenges of developing pharmaceutical nanoparticles.

  1. HTPD/Smart PD panel discussion   
       Michael Doherty, Codiak BioSciences

At HTPD 2023, attendees will have the opportunity to explore new possibilities and gain a deeper understanding of bioprocess development while utilizing fewer resources. This conference provides a platform for participants to connect with scientists who share similar challenges and interests, opening the door for future conversation.

During this panel discussion, attendees will hear from experts with diverse backgrounds across a wide spectrum of modalities, offering a glimpse into how HTPD and Smart PD are applied in real-world situations. The panel format allows for a candid discussion about the industry's challenges, successes, and limitations in meeting current and future targets. This session promises to be both practical and thought-provoking and will provide an outlook to HTPD needs and applications for the years to come.

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 (3) your contact information to the website or to the conference organizers latest by Sep 4th.

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  1. Frontiers in HTPD/Smart PD  
        Stefan Hepbildikler, Roche, Germany / Sheng-Ching Wang, Merck & Co, US

High-throughput process development (HTPD) has been successfully applied in many academic and industrial labs before and during the pandemic, in end-to-end CMC development, and across therapeutic modalities. More recent challenges include the support of a) connected and continuous process development, and b) the next level of accelerated CMC development in order to fight the pandemic.

This session invites speakers to present the latest trends and concepts in HTPD including learnings from the pandemic. How could high-throughput-related platforms, workflows and development strategy help to accelerate CMC  timelines even further without compromising patient safety? How do high-throughput platforms perform regarding environmental sustainability? How can we reduce waste and improve waste management? In addition, contributions addressing innovative approaches to develop and characterize new unit operations, to support health authority submissions by HTPD as well as any other novel approaches such as further miniaturization, are enthusiastically welcomed.

 

7 Poster Session 

 

  

Pre-conference day Monday October 30: Chromatography Modeling Day (included in registration fee)

Join the pre-conference sessions on mechanistic modeling to quickly get up to speed on the latest advancements of model-based process development.

The sessions guided by Cytiva modeling specialists cover an introduction to the topic, benefits and basic workflows of in silico process development and a deep dive into case studies and further fields of application.

The pre-conference sessions are organized by Cytiva and are only available for registered attendants of the HTPD conference. They are optional and come without any additional charge.

Some highlights from the Chromatography Modeling Day agenda:

  • Chromatography process development going smarter
  • Interactive GoSilico™ Chromatography Modeling Software demo
  • Case studies and best practices
  • Getting started – prerequisites and solutions for model-based process development
  • Meet the modeling community