Speakers & Sessions

Gerben Zijlstra

Global Technology Consultant Intensified & Continuous Biomanufacturing at Sartorius Stedim Biotech

Novel tools for Developing and Implementing Intensified Cell Culture Processes at Scale

Process intensification, including intensification by continuous processing, has become a major trend in biomanufacturing and allows manufacturers to produce more than 1000 kg of Mabs from fast to build and flexible Single Use and multi-product facilities. However, developing intensified processes and performing them robustly at scale is not trivial. Here, case studies showing the benefits of novel automated high throughput tools for perfusion process development will be shared. Furthermore, case studies of novel GMP manufacturing scale tools be presented, including new Rocking Motion (RM) Perfusion bioreactor for seed train intensification, Stirred Tank (STR) Bioreactors for intensified Cell Culture and clarification and capture tools.

Marcus Bayer

Market Segment Manager Single Use at Hamilton Bonaduz AG

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Single use sensors in actual process setups for biopharma applications

Chris Palmer

Tubing Product Manager at Watson-Marlow Fluid Technology Group
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Single use pumptubing for continuous bioprocessing

Willem Van Der Niet

Senior Sales Manager, Biopharm Systems EMEA at Pall Life Sciences

Process Intensification with the Pall Cadence platform

Presentation on the Pall Cadence continuous technologies and how their use can intensify your process.

Guy de Roo

Principal Scientist at Synthon Biopharmaceuticals

Process development and manufacturing of antibody-drug conjugates using single-use technologies

Antibody-drug conjugates (ADCs) are biopharmaceuticals consisting of a monoclonal antibody linked with a highly potent cytotoxic drug. The purpose of the antibody is primarily to target the drug to receptors on tumor cells and secure internalization while the function of the cytotoxic drug is to kill the targeted tumor cells. A major focus during the manufacture of ADCs is protecting a product from contaminants in the environment of a production facility but also the protection of employees within that environment from exposure to what can be very hazardous substances. While the use of glass or stainless-steel systems may effectively protect operators, significant equipment decontamination and cleaning validation is required. As an alternative, single-use technologies offer specific benefits but also come with challenges. The approach and challenges to handle safely both antibodies and high potency molecules (ADC, cytotoxic linker drug) will be presented.

Joris van de Velde

Application Engineer, Separation and Purification Sciences Division at 3M

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DNA clearance at clarification is the key to efficient mAb process design

Single use depth filter capsules and sterilizing grade membranes are well established technologies used in the clarification steps for mAbs and other therapeutic proteins. Yet, challenges with clarification robustness and variability in soluble impurity levels remain. Chromatographic clarification strategies enable more robust processes and deliver significant impurity reductions at an early stage in the process. In this session, we will focus on the importance of DNA removal and how it affects protein A chromatography performance and downstream processing challenges.

Dirk Martens

Associate professor animal cell technology at Wageningen University & Research

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The relevance of cell size in cho fed-batch process

In a fed-batch process, using a commercially available media system, a switch is observed from a cell proliferation phase to a phase where cell division is arrested and cell growth continues in the form of a threefold increase in cell size and dry weight. Metabolic flux and transcriptome analysis is applied to better understand the biological mechanisms associated with this switch and the consequences for culture processes are assessed.

Piet den Boer

Senior scientist, Downstream Processing Development at ProPharma group

Bastiaan Vliegenthart

Associate Consultant, Compliance and Validation at ProPharma group

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Extractables & Leachables assessments in single-use systems

In the manufacturing process of biologicals, a substantial number polymeric single-use systems (SUS) are utilized. Even though the industry has demonstrated that SUS can be used safely in biopharmaceutical applications, a concern remains regarding the potential for compounds leaching from the polymeric components. An Extractables & Leachables (E&L) assessment is an important tool that identifies and evaluates the E&L risk on patient safety and can help the manufacturer to determine whether the risk of leachables is acceptable. Relevant aspects of an E&L risk assessment will be shared.

Tom van Arragon - Applikon

Marcel Flikweert

Senior scientist at Janssen Biologics

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Use of PI and SIMCA-online to Build a Real-time Multivariate Monitoring System

Janssen Pharmaceuticals collects and stores large amounts of process data in multiple PI systems. It can be challenging to observe trends when there are 10+ variables impacting process performance. In this presentation Janssen outlines an application of multivariate statistical process control (MSPC) using PI data and SIMCA-online in their biologics manufacturing environment. Multiple variables across batches are monitored in real-time to detect any developing trends that may affect the batch performance. In this presentation, key objectives, system benefits, challenges and plans for future work will be included, as well as examples of system performance such as detected process deviations.