Cambridge Healthtech Instituteの第6回年次会議

Cell Culture and Bioproduction
(細胞培養とバイオプロダクション)

新興技術、プロセス制御の向上、新たな機会

2023年3月14 - 15日、CET(中部欧州標準時)

Cambridge Healthtech Instituteの第6回「細胞培養とバイオプロダクション」年次会議では、細胞培養の生産性を向上させ、これらのシステムを臨床・商業生産用にスケールアップするための技術と戦略を検討します。新しいバイオリアクター技術、デジタルツールやビッグデータの役割の増加、新しいプロセス制御システム、精密発酵や細胞農業といった新興分野におけるこれらのツールの応用などを取り上げます。

3月14日(火)

Registration and Morning Coffee07:00

ADVANCES IN PROCESS CONTROL
プロセス制御の進歩

08:25

Chairperson's Remarks

Moritz von Stosch, PhD, Chief Innovation Officer, Datahow, Switzerland

08:30

Monitoring Morphological and Dielectric Properties of Cells during a Bioprocess

Michael Butler, PhD, Principal Investigator, Cell Technology, National Institute for Bioprocessing Research & Training (NIBRT), Ireland

Optical and dielectric technologies allow the continuous monitoring of mammalian cells in a bioprocess without the need for manual sampling or labeling, as well as cell counts the new methods provide data on the state of the cells. For example, optical methods can determine the changing morphology associated with the loss of viability. Capacitance measurements can determine changes in cytoplasmic conductivity indicative of the first stages of nutrient deprivation. The combination of these methods allows fine control during biopharmaceutical production processes.  

09:00

Closed Loop Control for Achieving Optimum Productivity

Christoph Herwig, PhD, Head of Research Area Bioprocess Technology, TU Vienna, Austria

Continuous bioprocessing not only needs automation to control conditions, but control strategies to optimize productivity. This holds true for mammalian and microbial expression systems, in which the metabolic load to the cells may increase over time. This contribution will show digital twin-based control strategies how to achieve optimum specific productivity of recombinant protein production.

09:30 Smart PAT - Shifting Quality Control to the Shop-Floor

Giovanni Campolongo, Senior Market Segment Manager Process Analytics, Process Analytics, Hamilton Bonaduz AG

Biopharma production quality controls are traditionally performed off-line in the lab. This impacts the process's productivity. A shift towards smart in-line Process Analytical Technology (Smart PAT) is required to improve it. This involves:

 

  • New real-time measurement technologies to measure PAT Critical Process Parameters and Key Performance Indicators during the process
  • Progressing digitalization to enable innovative process analytics, advanced process control and asset management

Sponsored Presentation (Sponsor Opportunity Available)09:45

Grand Opening Coffee Break in the Exhibit Hall with Poster Viewing10:00

10:45

KEYNOTE PRESENTATION: Production of SARS-CoV-2 VLP in CHO Cells

Yves Durocher, PhD, Research Officer & Head, Mammalian Cell Expression, National Research Council Canada

Chinese Hamster Ovary (CHO) cells are the workhorse expression host for manufacturing glycoprotein-based biotherapeutics. However only a very few commercial vaccines are manufactured in CHO cells as of today. We show that CHO cells are indeed well amenable to manufacture subunit vaccines, as exemplified with the SARS-CoV-2 trimeric spike antigen. We also show that engineered CHO cells are capable of generating high levels of enveloped VLPs harboring very high density of trimeric spikes at their surface, representing another prospective vaccine candidate. CHO cells thus demonstrate very strong antigens manufacturability potential and should be considered for next-generation vaccine candidates.

CELL CULTURE MEDIA OPTIMISATION
細胞培養培地の最適化

11:15

Best Practices for Media Optimization

Antoine Piednoir, Scientist, Upstream Process Development, UCB, Belgium

At UCB, we employ a range of strategies for cell culture media optimization, and these have been evolved over time to minimize cost and resources and to meet important internal deadlines. The presentation will share our learnings from these experiences and recommend best practices for our industry colleagues working on similar projects.

11:45

In silico Media Optimization

Rui M. Oliveira, PhD, Associate Professor, Systems Biology & Engineering, Chemical Engineering & Biochemistry, Nova School of Science and Technology, Portugal

Hybrid modelling tools were developed for in silico culture media design with minimal wet lab activity requirements. Hybrid flux balance analysis tools (Hybrid-FBA) were developed combining a genome-scale model (GEM) of CHO-K1 cells with empirical information deduced from principal component analysis (PCA) of historical data. A key advantage is the ability to learn from experience. While the GEM is a fixed part of the model, the PCA (and the hybrid ensemble per inherency) will improve with each new cultivation performed. After sufficient validation cycles, the developed tools can be used to design ab initio custom feeds for every new molecule.

12:15 Enabling Real-Time Process Control: Automated Glucose Feeding Based on Online Measurement

Nick Randall, Bioprocessing Product Manager, 908 Devices

Faster development cycles, intensified processes, and automation of process control are key-initiatives in biotherapeutics manufacturing. However, offline analytics requiring manual intervention are commonly used to monitor critical and time-sensitive process parameters. We describe a new automated approach for optimal growth and production, leveraging sensitive, online (sample-free) monitoring of glucose & lactate with automated feed control, and its impact on growth/viability, lower metabolite, and improved PQA.

Networking Lunch (Sponsor Opportunity Available)12:45

MODELLING AND MACHINE LEARNING IN UPSTREAM PROCESSING
上流工程プロセスにおけるモデリングと機械学習

13:45

Chairperson’s Remarks

Mark Duerkop, CEO, Novasign GmbH, Austria

13:50

Can Genetic Algorithms and Machine Learning Improve the Quality of a Mammalian Manufacturing Platform?

Marco Cardinali, AI/ML Engineer, GlaxoSmithKline, Italy

Machine learning models used in mammalian cell cultures can leverage both historical and real-time data, with the final goal to ensure a consistent product output quality and optimised process operation. We will show how a state-of-the-art model can design optimal experimental setups in an active learning scenario, bringing an improvement both in the quality of the data produced by experiments, and in the yield and robustness of the process itself.


14:20

Continuously Accelerating Process Development with Machine Learning Supported Knowledge Transfer

Moritz von Stosch, PhD, Chief Innovation Officer, Datahow, Switzerland

Quality by Design (QbD)-guided bioprocess development is cost effective only if knowledge is transferred from one project to the next (horizontal knowledge transfer) and one scale to the other (vertical knowledge transfer). We developed a novel hybrid machine-learning method to allow model processes across scales, projects, and products. This method retains and transfers knowledge, reducing experiments across scales and for the development of a process of a new product.

14:50 Talk Title to be Announced

Speaker to be Announced

Refreshment Break in the Exhibit Hall with Poster Viewing15:20

15:40

Hybrid Modeling, Digital Twins and Advanced Process Control: Status Quo, Pitfalls, and Solution Paths to Accelerate Bioprocess Development

Mark Duerkop, CEO, Novasign GmbH, Austria

Sufficient process understanding in the QbD concept is a cumbersome task. Hybrid modeling and advanced design space screening methods reduce the required experimental effort to reduce overall development timelines. Conserving process understanding in these models enables model transfer from early-stage development until manufacturing. The presentation will cover model-assisted process characterization, process optimization, implementation of soft-sensors, and a model predictive control showcase. The audience will learn how to set up strategies for implementation of process modeling and digital twins and which pitfalls have to be overcome in order to accelerate the development from early-stage development until manufacturing. 

OPPORTUNITIES IN PRECISION FERMENTATION AND CELLULAR AGRICULTURE

16:10

Agriculture in a Bioreactor Needs More than a Beefed-Up CHO-Bioprocess

Andy Racher, PhD, CTO, HigherSteaks, United Kingdom

Following the launch of Eat Just's chicken nuggets, bioreactor-grown meat is now available at commercial outlets in Singapore. Other companies, using species such as Bos taurus or Sus scrofa, are developing technologies for manufacturing meat. Creating pork from a porcine cell line is more than simply using a high-intensity CHO-process to grow cells. This talk discusses challenges the nascent industry faces, learnings from the CHO-world, and where new thinking is needed if cell-based meats are to find space in supermarket aisles.

16:40

Future of Cheese: The Evolution from Cows to a Fully Digitized Casein Production Platform

Eva Sommer, PhD, CEO & Founder, Fermify, Austria

Bioprocesses for large-scale protein production are generally known to be labor-intensive, time-consuming and inefficient in the usage of assets. To ensure commercial viability of protein manufacturing for food application-- such as precision fermentation-derived caseins for human consumption - it is essential to rethink the entire bioprocess design, from GRAS strain engineering to lean downstream processing as well as a smart conceptual design that leads to a tremendous CAPEX reduction.

17:10 Talk Title to be Announced

Speaker to be Announced

17:25 Talk Title to be Announced

Speaker to be Announced

Welcome Reception in the Exhibit Hall with Poster Viewing17:40

Close of Day18:45

3月15日(水)

Registration and Morning Coffee08:00

OPTIMISING UPSTREAM PROCESSING
上流工程プロセスの最適化

08:25

Chairperson’s Remarks

Michael Butler, PhD, Principal Investigator, Cell Technology, National Institute for Bioprocessing Research & Training (NIBRT), Ireland

08:30

FEATURED PRESENTATION: Digitalisation of Cell Culture Operations Enabling Better Clone Selection and Scale-Up

Stephen Goldrick, PhD, Lecturer, Digital Bioprocess Engineering, University College London, United Kingdom

This research outlines the development of a data-driven methodology to enhance lead clone selection that not only considers the available titre concentration and product quality information but also leverages the significant untapped data resource containing all the available offline, online and metadata. To help automate this selection process the research outlines the use of a simple natural-language-generation (NLG) algorithm to summarises the large volume of information into a human-readable report.

09:00

Across Scales: An Integrated Robotic Cultivation Platform for Accelerated Bioprocess Development

Peter Neubauer, PhD, Lab Head, Bioprocess Engineering, TU Berlin, Germany

KIWI-biolab enables the efficient development and optimisation of bioprocesses on a robotic platform with parallel bioreactor systems of different sizes, analytical instruments and a mobile laboratory robot. The focus is on well-controlled, parallel, miniaturised fed-batch cultivations with fully integrated sample analysis and mathematical, model-based decision-making to feed-back control the ongoing experiments for maximum knowledge gain. The power and opportunities of the platform are demonstrated by several industrially relevant recombinant processes.
09:30

Strategies for Resolving Sustainability Issues with Single-Use Plastics

Olivier Cousin, PhD, Head, GSK Vaccines MSAT Environmental Sustainability, GlaxoSmithKline, Belgium

Environmental impact and plastic waste management is a sensitive topic for the pharma industry during the evaluation of changes in manufacturing processes. New SUT could represent a disruptive cluster of technologies compared to the more embedded Stainless-Steel Systems or classical technologies as well. In this essay we purpose a supporting methodology that can give an aid to decision-making illustrated via specific vaccines' business cases.

10:00 Next-Generation Upstream Processes: What are the Key Enablers?

Andreas Castan, PhD, Strategic Technologies Leader, Cytiva

The journey from molecule discovery to manufacturing can be challenging, and market success is heavily dependent on the swift creation of high-performing processes. Cell culture scientists drive this success by striving for scalable, robust processes that reach target titers and deliver consistent product quality profiles. This talk discusses enablers for these next-generation bioprocesses with an emphasis on cell line development, process development, process intensification, scale up, and automation.

Coffee Break in the Exhibit Hall with Poster Viewing10:30

PLENARY SESSION: EMERGING MODALITIES, PLATFORMS, AND TECHNOLOGIES - FROM mRNA TO PROTEINS
基調講演:新興のモダリティ、プラットフォーム、技術 - mRNAからタンパク質へ

11:15

Chairperson's Opening Remarks

Margit Holzer, PhD, Owner, Ulysse Consult

11:20 PLENARY PRESENTATION:

Overcoming CMC and Supply Chain Challenges for mRNA Technologies

Gregory Troiano, Chief Manufacturing Officer, mRNA Center of Excellence, sanofi

Thanks to the rapid development of mRNA vaccines for COVID-19, the industry now has the momentum and resources to overcome many of the early CMC challenges and realize its enormous potential. This presentation will discuss the strategies in place to overcome CMC and supply chain challenges for mRNA technologies already and future innovations primed to take it to the next level.

11:50 PLENARY PRESENTATION:

Affinity Proteins for Biotechnological and Medical Purposes

Sophia Hober, PhD, Professor, School of Biotechnology, KTH Royal Institute of Technology

Affinity proteins are crucial for life, for building structures, performing reactions, and for signaling purposes. In life sciences and medicine, affinity proteins are used to generate knowledge, but also for diagnostic and therapeutic purposes. This talk will cover how antibodies and small affinity molecules can be used to map the human proteome, develop diagnostic tools for in vivo visualization as well as efficiently purify therapeutics based on antibodies.

Transition to Sessions12:20

12:30 Designing Purification Strategies for Bispecific Antibodies Based on Molecule Design

Jakob Liderfelt, Global Product Manager - Antibody Polishing, Cytiva

Developing purification protocols for multispecific antibodies present extra challenges compared to conventional therapeutic monoclonal antibodies (mAbs). Strategies for efficient capture and polishing are discussed already in antibody engineering. Strategies include available resins and methods and need to give sufficient separation of product and process related impurities. This presentation covers different aspects of designing a GMP purification process for bispecific antibodies.

Networking Lunch (Sponsor Opportunity Available)13:00

Close of Cell Culture and Bioproduction Conference14:00

* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。

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Prelim Agenda Now Available

3月14 - 15日

CELL CULTURE AND BIOPRODUCTION

ADVANCES IN RECOVERY & PURIFICATION

GENE THERAPY CMC AND ANALYTICS

CELL THERAPY MANUFACTURING

ANALYTICS AND CHARACTERIZATION

3月14 - 15日

CELL LINE DEVELOPMENT

INTENSIFIED & CONTINUOUS PROCESSING

GENE THERAPY MANUFACTURING

CELL THERAPY CMC AND ANALYTICS

FORMULATION AND STABILITY