Ron Gott works as a Techincal Lead focusing on developing new products and technologies in Fluid Transfer and Containment Applications with the PharmBIO division of Gore. He focuses primarily on pump tubing technology used in end-to-end applications. Ron holds a Bachelors degree in mechanical engineering from the University of Michigan.

Dr. Marie-Laure Erffelinck is a Senior Scientist at Sanofi's Large Molecules Research in Ghent, Belgium. She received her PhD in Biotechnology from Ghent University in 2016, conducting research at the VIB Center for Plant Systems Biology.

Dr. Erffelinck transitioned to industrial biotechnology in 2019. At Biotalys, she established and led a microbial host development platform for protein-based biocontrol products.

At Sanofi's Technology & Innovation team in Early CMC, she spearheads strategic initiatives to optimize NANOBODY® manufacturing platforms and implement innovative technologies. She leads cross-functional projects aimed at enhancing biopharmaceutical production processes, with particular focus on improving process robustness and scalability. Dr. Erffelinck's work is pivotal in bridging cutting-edge scientific discoveries with practical manufacturing solutions, contributing significantly to accelerating the development of complex therapeutic proteins from concept to clinical application.

Oliver studied Biotech at BOKU University in Vienna before doing a PostDoc at KTH in Stockholm. Since 2010 he has been employed at TU Wien at the Institute of Chemical, Environmental and Bioscience Engineering. In 2015 he habilitated in the field “Biotechnology” and he has been appointed Full Professor in Biochemical Engineering in 2023. He is leading the research area of Biochemical Engineering at TU Wien.

A bioprocess engineer by education, for >10 years, Caroline has been working in cGMP environment within international biopharmaceutical companies focused on delivering innovative large
molecules therapies, including monoclonal antibodies and coagulation factors. With significant experience in setting-up new bioproduction suites (both Single-Use and Stainless Steel) and bringing new molecules to the market, Caroline has hands-on and confirmed knowledge in process development & validation, operational quality and production, CAPEX & tech transfer projects management. After 4 years as Upstream Manufacturing Sciences manager at Biogen, Caroline is now leading the Quality Operations and Quality Engineering group across two separately operating biomanufacturing cells, equivalent to two Large Scale Manufacturing facilities at Biogen in Solothurn.

As Senior Bioprocessing Scientist in CMC development with over 20 years of experience:

2020-2024 Former Head of Mid and Late Stage Process Sciences at UCB Pharma, Braine L’Alleud, Belgium, overseeing process design, optimization and characterization studies of upstream and downstream processes, cell culture media and feed development, cell banking in cell culture and microbial fermentation processes, leading cross functional process science teams in Belgium and UK.

2017-2020 Digitalisation Lead & Senior Principal Scientist at Roche, Penzberg, Germany, directed digitalization and digitalization transformation across the large molecule research unit, spearheaded cross-functional, international teams and projects for data management and data science

2007-2017 Group Leader and Pilot Plant Manager for Cell Culture Research within Pharma Research and Early Development at Roche, Penzberg Germany, managed an early upstream process development team and led portfolio projects from cell line development to first in human.

2003-2007 Head of Cell Culture Research Pilot Plant at Sanofi, Frankfurt, Germany, establishing and managing a new cell culture pilot plant for clinical Phase I/II supply of upstream and downstream processes

Bioengineer graduated from the Technische Universität Berlin Germany. Did a PhD in cancer research at the Private Universität Witten/Herdecke working on Cancer cell migration. Worked in various functions in different business fields within the commercial Life Science organization of the Merck group since then. Now working as a Applications specialist for the Downstream portfolio products of the Biopharma Process Business Division. www.linkedin.com/in/daniel-palm-58278247 
 

Alessandro is an experienced leader and Global MSAT Associate Director, Global Harvest & USP SME at Lonza, bringing over a decade of international experience in Manufacturing Science and Technology (MSAT). Starting his career with R&D and quality roles, he advanced to lead complex tech transfers, process design, and scale-up projects for biologics, spanning pilot to 25kL Mammalian and up to 240kL Microbial GMP Facilities.
At Lonza, Alessandro has been instrumental in driving innovation and harmonization across the global network as a Global Primary Recovery Manager, chairing key global governance forums. His expertise covers regulatory inspections, process qualification, hydrodynamics and harvest scale-up and leading multidisciplinary teams, solidifying his role in shaping future drug manufacturing capabilities.

Abstract

At Lonza, continuous improvement in biomanufacturing is an important business driver. In recent years, upstream process intensification such as n-1 perfusion reactors have emerged as a rising technology that can offer promising advantages for biologics manufacturing, including higher productivity and reduced timelines. However, process intensification upstream also introduces new challenges for downstream processing. By significantly increasing cell density and titer, this approach can dramatically uplift biologics output while also straining existing recovery systems.

Here, we explore how single-use centrifuge deployment at GMP scale addresses these challenges and provide potential opportunities to improve throughput, reduce impurities, and lower overall process CoGs. We highlight real-world pilot data from 1kL and 2kL bioreactors as a positive indication of the innovation’s scalability and commercial viability.

Dr. Hiroko Shimada-Kreft earned her Ph.D. in medicinal chemistry and molecular pharmacology from Purdue University in the USA. She held research and academic positions at the Center for Advanced Research in Biotechnology, Sacred Heart University, and Yale University, supported by a prestigious NIH fellowship. Transitioning from academia in 2008, she became a Biotech Consultant at Trenzyme Ltd. in Germany before joining Nestlé’s Product Technology Centre. She later worked at Takeda Ltd., as Associate Director for Vaccine Research and Analytics. In 2023, Dr. Shimada-Kreft joined BioNTech SE as Director Global Technical Development.

Abstract

True to the vision statement, BioNTech is committed to translating “science into survival”, which also comes with CMC challenges. This presentation is to share the current state and priorities of the company, emphasizing the approach to leverage the prior knowledge in the emerging modalities.

Nicolas Pivet’s ability to find the right creative solution for customers is at the root of his delivery-focused mindset. Innovation is second nature to him, which allows him to bring fresh approaches to meeting customer needs.

He is a seasoned leader in the Healthcare industry, with laser-sharp customer focus and experience across R&D, product management, service operations, commercial and strategy.

Nicolas has spent 20 years in the medical device industry, at GE Healthcare. Since 2017, he serves the Biopharma industry with GE Life Sciences that became Cytiva, part of Danaher.

Nicolas currently leads Cytiva’s global Manufacturing Capacity & Digital Solutions Business Units, developing & delivering technology solutions enabling fast, flexible, and reliable process development and manufacturing for the biopharma industry.

Nicolas graduated from Ecole Polytechnique and Telecom Paris, with two MSs. He is a certified Lean and Six Sigma Master Black Belt. He lives in the Paris area.

Abstract

How Cytiva digital solutions enhance the performance of both equipment and drug process:

Automation with Figurate™: This software automates processes, saving time and money while reducing risk
Bioreactor Scaler: An in silico tool that optimizes bioreactor settings for scaling, reducing risk and time for cell culture transfers
GoSilico™ Chromatography Modeling Software: simulates downstream chromatography processes, improving robustness, saving time, and enhancing output
Data Bridge: A digital solution for delivering electronic certificates of analysis and raw material data directly to quality systems
OptiRun™ Connect: A cloud-based asset monitoring platform that provides proactive asset health maintenance
Process Analytical Technology (PAT): Combined breakthrough inline sensors and software for advanced process controls

Cytiva's digital solutions can significantly improve biopharma processes by enhancing speed, flexibility, and reliability, ultimately leading to better performance, reduced costs, and accelerated development milestone

Bassem Ben Yahia is part of DS Biologic Process Sciences Group at UCB Pharma in Belgium since 2011 and is focusing on new process technologies for cell culture technologies, media development, process optimization, process intensification and process modeling. He is heading a team of talented scientists developing best in class, well characterized and controlled, high quality processes from ph2 to launch and lifecycle management. Passionate about biology and modelling biological systems, Bassem holds a PhD degree (2017) in Biochemistry & Biochemical Engineering from University of Saarlandes in Germany focused on predictive macroscopic modeling of Chinese hamster ovary cells in fed-batch processes. During his PhD, he successfully developed simple and robust modeling methodologies to predict cell culture performances which is currently used at UCB to accelerate early stage process development.

Multidisciplinary engineer with deep expertise in purification technologies, process modelling, and continuous manufacturing, supporting innovation and efficiency in the pharmaceutical and chemical industries. Work includes detailed cost modelling, enabling smart investment and operational decisions.
Passionate about automation and digital transformation, with a strong focus on process integration and control strategies to enable robust, scalable continuous systems with hands-on experience in basic MATLAB and Python application for data processing.

Beyond technical expertise, I’m an advocate of Lean management and EHS culture, facilitating cross-functional improvements, driving operational excellence, and ensuring value delivery at every step. Passionate about mentoring and coaching to cultivate high-performing teams.

Abstract

• Established a simplified and adaptable workflow for SMCC process design for wide range of antibody processes and titre levels.
• More than three-fold improvement in productivity and more than a 20% reduction in resin utilization compared to conventional batch process.
• Potential for applications to New Molecular Formats and quick integration with continuous downstream process stream.

Vivek Halan is the Senior Group Leader of Primary Recovery and Process Optimisation at Lonza Biologics, with over 18 years of experience in downstream process development for biologics. He has a proven track record in developing robust purification processes for monoclonal antibodies, bispecifics, and Fc-fusion proteins. Vivek has been instrumental in advancing high-throughput purification technologies and is passionate about driving innovation in biomanufacturing through process intensification, automation, digitalisation, and predictive modelling. His current focus is on tackling host cell protein challenges and improving downstream efficiency through intensified unit operations.

Abstract

Advances in upstream processes and the application of cell culture intensification strategies significantly boosts product titre and have the potential to lower the overall cost of goods. These high performance production processes, mainly driven by higher cell densities in the production bioreactor, present a new set of challenges for the purification process : (i) increased cell mass reduces filter throughput (ii) elevated concentrations of soluble impurities poses additional challenges in the subsequent purification steps and (iii) increased product mass and process volumes create facility throughput bottlenecks. As the biopharmaceutical industry continues to move toward higher throughput, operational flexibility, and faster turnaround times, there is a growing need to intensify downstream processing (DSP). These efforts aim, not only to resolve capacity limitations and process bottlenecks, but also to further reduce cost and improve process robustness.

The first part of the presentation will outline a range of downstream process intensification strategies aimed at improving the process performance, process time, reducing the footprint, and enabling connected or continuous manufacturing to improve the productivity. It will cover advances in primary separation, capture and polish chromatography intensification as well as process volume management strategies combined to streamline downstream processing and improve scalability, efficiency, and final product robustness.

The second part will present two case studies that illustrate DSP intensification approaches. The first case study will illustrate how several capture step technologies can be combined to greatly improve productivity. The increased titre, resulting from intensified fed batch upstream processes, can be adequately managed, while still meeting the process and product quality targets.

The second case study will showcase the intensification of a cation exchange (CEX) chromatography step of a monoclonal antibody (mAb) product. A comparison of the aggregate removal capabilities of two resins, one performed in flow-through mode and the other in bind/elute mode will be made. It will be illustrated how the increased titre and aggregate concentration, resulting from and intensified fed batch upstream processes, can be managed effectively with acceptable purity and yield.

The presentation highlights how intensified upstream processes can increase downstream challenges, driving the need for DSP intensification to overcome capacity bottlenecks and improve robustness. DSP intensification also paves the way for faster, more sustainable, and cost effective biomanufacturing.

Haiko Fischer joined Asahi Kasei Bioprocess in December 2017. He has been a member of the R & D team for three years and is now the Product Manager for Germany, Austria, Switzerland, and Eastern Europe. Haiko studied Chemical and Process Engineering, and as Product Manager, he assists his customers with all technical questions regarding Planova Virus Filters and BioOptimal Microfilters, as well as providing training on the respective products and technologies.
 

Dr. Rudger Thomas Hess is a Principal Scientist specializing in downstream process development (DSP) at Boehringer Ingelheim Pharma GmbH & Co. KG. With a strong foundation in chemical- and bioengineering, he earned his Dr.-Ing. from the Karlsruhe Institute of Technology, where he graduated summa cum laude. His doctoral research focused on predicting therapeutic antibody behavior in multimodal chromatography.

Dr. Hess has extensive experience in chemistry, manufacturing, and controls (CMC), as well as DSP process and technology development, having held various roles at Boehringer Ingelheim, including Principal Scientist and Postdoctoral Researcher. His expertise includes mechanistic and statistic process modeling, flow-sheet simulation, automation, quantitative structure-function analysis, process analytical technology (PAT)/chemometrics, and molecular dynamics simulation.
He has published several first-author papers in the Journal of Chromatography A and has presented his work at numerous international conferences.

Ahir Pushpanath holds a Bachelor's degree and PhD from UCL/Birkbeck and has dedicated over a decade to pioneering advancements in biocatalysis. His career began at Johnson Matthey (JM), where he built the company’s biocatalysis capability from the ground up, later expanding into bio-innovation projects with cutting-edge startups. Now serving as the Techno-Commercial Director at bitBiome—a visionary Japanese company positioned to drive the foundation of the bio-economy—Ahir champions the transformative power of computational approaches and AI in bio-manufacturing. Recently recognized by Thermo Fisher as "the man catalysing a bio-revolution," Ahir continues to lead advancements at the intersection of biotechnology and AI, shaping sustainable manufacturing for the future.
 

Sanjeev Ahuja currently serves as the Executive Director of Biologics Process Development group in MSD at NJ, USA. Sanjeev earned his integrated Bachelor’s and Master’s degrees in Biochemical Engineering and Biotechnology from Indian Institutes of Technology in Delhi, India and then his PhD in Chemical and Biochemical Engineering from University of Maryland Baltimore County (UMBC). Sanjeev has extensive industrial experience in development and commercialization with expertise in mammalian/microbial processes for proteins, vaccines, and cell therapies. Of note, Sanjeev served as an Adjunct Faculty from 2008-2020 in the Master of Professional Studies program in Biotechnology at UMBC. Moreover, he has published/presented extensively in research areas that have influenced the bioprocessing field, including high titer process development, antibody reduction. and machine learning. Enthusiastic about business-centric disruptive innovation, he is currently steering his team to manage a complexly evolving pipeline while developing next generation fed-batch and continuous-manufacturing bioprocesses.  

Dr. Manoj earned a PhD in Materials Chemistry from NYU Tandon School of Engineering in 2012. He started his professional career in Bio-based chemical company startup and incorporated biocatalysis for industrial applications. In 2018, he joined Regeneron and has since accumulated seven years of experience in biopharmaceutical downstream processing and investigations. Currently, they lead a team of 10 professionals specializing in high-throughput automation and analytics. Their research expertise spans diverse fields, including automation, protein purification, assay automation, filtration, polymer chemistry, biodegradable polymers, enzyme immobilization, and bio-catalysis. Dr. Manoj Ganesh has also contributed significantly to scientific literature, with seven journal articles, one book chapter, and one awarded patent to their credit.

Abstract

An end-to-end automated high-throughput approach has become essential in addressing these challenges, enabling rapid data driven decisions from high-throughput lab studies. Our vision for end-to-end lab automation is to seamlessly integrate purification, filtration, analytical, and data analysis workflows. There are several gaps and challenges to achieve the full end-to-end lab automation. First, filtration steps still need more efforts from vendor collaborations to overcome the challenges of designing and commercializing filter plates. The filter plates should be automation friendly and robust, and would require end-user evaluations to assess the scalability and well-to-well variability. Secondly, when integrating purification and analytical workflow, the limited volume of material produced by liquid handlers presents another challenge for analytical testing. Lastly, advanced data analysis technique can be critical for end-to-end automation. Our latest efforts will be presented on overcoming those challenges to enable end-to-end automation platform. Case studies on filtration automation development and analytical advancements using LC-MS based Multi-attribute method (MAM) will be presented.  

Alexandre is a Lead CMC Statistician within the Centre of Expertise CMC Statistics at UCB Pharma. He is responsible the development and implementation of statistical and modelling approaches for biologics throughout their lifecycle, from the early stages of
technical development all the way to commercial manufacturing.

Berthold Bödeker brings more than 35 years of experience in Biologics Research, Development and Production throughout his career at the Bayer Group in Germany and the US. During this time he was involved at different levels of responsibility in the development of more than 35 biologics with experience ranging from Phase 1 Clinical to Commercial Production. His latest Bayer title was Chief Scientist for Biologics

In addition, he was member of many biotech industry organizations such as Biophorum Development, EuropaBio, DIB, ACTIP, BioRiver etc.

Since 2019 after retirement from Bayer he has been working as an independent consultant before joining the Norwegian Biotech start-up Tribune Therapeutics AS in April 2022 as Chief Technology Officer. Currently he is primarily responsible for the CMC development of the lead compound TRX-44, an albumin fusion protein.

Abstract

This talk will summarize our experience as a semi-virtual small biotech company without own CMC infrastructure, how to manage early development towards production and release of phase 1 clinical material using our lead compound TRX-44 an albumin fusion protein directed against fibrotic diseases.

More than 30 years academical and industrial experience in animal cell technology.

• PhD studies about the cell protective effect of Pluronic F-68 in a serum-free medium at the ETH Zurich.
• Pioneering work and proof of concept for transient expression of recombinant proteins in striired tank bioreactors (postdoc project at Genentech).
• 9 years of academic research on cellular biotechnology at the EPFL Lausanne.
• Since 2005 employed at the Merck Vevey manufacturing site as senior scientist focused on media development and optimization of fed-batch & perfusion processes.

From 03/2022 Senior Scientist, Boehringer Ingelheim Pharma GmbH & Co. KG Department: Bioprocess Development Biologicals

10/2019 – 02/2022 Scientist, Boehringer Ingelheim Pharma GmbH & Co. KG Department: Bioprocess Development Biologicals

02/2018 – 09/2019 PostDoc, Boehringer Ingelheim Pharma GmbH & Co. KG Department: Process Transfer & Manufacturing Science

04/2014 – 10/2017 Research Associate (PhD Student), Cell Culture Technology, Institute of Biochemical Engineering, University of Stuttgart

Abstract

The switch from lactate production to consumption is a key characteristic for mammalian bioprocesses and remains not fully understood to date. A robust and maintained switch towards lactate
consumption is associated with improved metabolic efficiency, growth, and productivity of the cells. Therefore, efforts are made to actively control this switch and robustly aintain the subsequent
status of the cell throughout the bioprocess. Dissolved oxygen (DO) is recognized as a critical process parameter in bioprocesses with significant influence on lactate metabolism. The presented study
aimed to confirm the impact of DO on lactate metabolism in CHO cells and to determine the extent to which the overall process performance can be nfluenced, dependent on exposure time and level.
The aim was to identify input factor combinations and predictive readouts that indicate early in the process the fate of lactate metabolism. With this knowledge, a better understanding of the metabolic
sensitivity to DO of CHO processes shall be achieved and then applied to define a robust DO profile/range in line with cellular dynamics that also considers process scale-up.

Dr. Abitorabi joined Bayer as VP, CGT Platform Implementation and is the Scientific Lead CT Technologies. He has >25 years of experience in product development and manufacturing. Prior to Bayer, he was Site Head of MSAT at Novartis,
Stein and part of the senior leadership team that established Kymriah clinical and commercial manufacturing. Prior to Novartis, Dr. Abitorabi led programs in industry and at the Department of Medicine, UC San Francisco. He is an inventor of many
products and processes, some commercialized. He has designed a new 3D process and is involved in the establishment of industrial scale manufacturing of cell therapy at Bayer.

Abstract
 

At Bayer, we have been developing technologies to scale up allogeneic cell manufacturing in 2D and 3D. A next gen industrial scale process has been developed to overcome one of the key limitations of providing CT to patients.

Cécile Brocard is a trained biochemist and molecular cell biologist. After earning her degree in France, she completed her PhD in Biochemistry at the University of Vienna, Austria. Currently, she serves as the Director of Downstream Development in the
Development Operations Vienna department at Boehringer Ingelheim Regional Center Vienna. Cécile leads a talented team responsible for developing downstream processes for a wide range of recombinant proteins expressed in microbials. Her
team's work is crucial for clinical supplies for Phase I, II, and III trials, and managing the tech transfer to production. She oversees downstream development units and a non-GMP pilot plant, driving technology programs and strategic initiatives.
Dedicated to fostering innovation and improving process flows, Cécile is committed to sharing her expertise and contributing to the global advancement of biotechnology.

Abstract
 

We have established an autonomous model-guided Design of Experiments (DoE) approach that significantly enhances efficiency and outcomes. By intelligently suggesting promising experiments, the model rapidly improves in quality and predictive power.
This method outperforms traditional DoE, requiring fewer experiments to achieve superior results. Impressively, the entire process is completed within just two days, offering a swift and effective solution for process development.This streamlined approach
aims to accelerate innovation and optimize resource utilization, making it a valuable asset for strategic decision-making during the development of biopharmaceuticals. We present a case study demonstrating the practical benefits and the potential of this a
pproach to drive superior process outcomes with greater efficiency and precision.

- Diploma in Biotechnology at Technical University Braunschweig, Germany
- PhD (Dr. Ing.) in Juergen Hubbuchs group at Research Center in Juelich, Germany
- 2007-2012: Development scientist at Novo Nordisk A/S, Denmark
- > 2012: Principal Scientist in Manufacturing Science and Technology department at Novo Nordisk Denmark

Abstract

Continuous capture chromatography is a chromatographic technique promising higher resin utilization, higher productivity and lower buffer consumption than traditional batch chromatography capture processes. The design of cSMB processes is more challenging than the design of batch processes because each chromatographic phase is influenced by the load from the previous phase and it is in turn influencing the subsequent phase. An iterative approach can be used to identify optimal conditions.

Our current process design approach is based on single column breakthrough curves and feeding the breakthrough data into a model. However, this concept leads to a sub-optimal process as it is based on a single loading flow rate, while effectively, flow rates and amounts in interconnected and parallel load phases can be different so using one flow rate only leads to sub-optimal processes.

We are presenting an approach where different flow rates and different breakthrough curves are used as model inputs together with pressure-flow dependencies for the resin of interest. Using the improved process design, significantly higher productivities were achieved than with the standard procedure. The effect was confirmed for a given in-house model process (mAb purification using Protein A affinity chromatography) where productivities could be increased by approximately 50% which has been confirmed at laboratory scale. The presented approach was also evaluated using mechanistic modelling. Finally, implications of the new cSMB design approach for large-scale manufacturing are discussed.  

David Nickel works as a Sr. Staff Engineer on the integration of modelling and digitalization into the standard workflows of Biotherapeutics Process Development at Takeda. He focuses on process modeling of unit
operations in up- and downstream using mechanistic, hybrid and AI approaches. David holds a PhD in industrial biotechnology from Chalmers University of Technology in Gothenburg (Sweden).

Since 2013 I am at Bayer AG, currently Lab Head Development Analytics. My main experiences lie in early and late-stage biologics CMC development with focus on monoclonal antibodies, antibody-drug-conjugates,
recombinant proteins and targeted-alpha-therapies. Prior to my role in analytics, I gained several years’ experience in downstream development at Bayer AG.From 2010 to 2013 I was a group head at Affimed
Therapeutics AG, responsible for the early development of bi- and tri-specific therapeutic antibodies, including antibody engineering, purification and analytics.My education resulted in a Degree in Biology
(Constance University, Germany) and a PhD in Biochemistry (Cardiff University, UK). After my PhD I was a Post-Doc at Harvard University with a research focus on disulfide bond formation, protein folding, protein export
and protein engineering.

Louis is the CSO and Management Board Member of JJP Biologics, an innovative new Polish Company backed by the Starak family. JJP Biologics develops the next generation of novel therapeutic biologics around
personalized medicine and companion diagnostics (JJP Biologics: Overview | LinkedIn). Louis was the founder of various companies focused on the generation and development of therapeutic monoclonal antibodies,
primarily in the field of cancer and inflammation. In 2003, he was one of the founders of Bioceros BV, now Polpharma Biologics, where he currently holds the position of Principal Scientific Advisor. In addition, he held
positions as CSO for MacroZyme BV, 4AZA Bioscience NV, FF Pharma, and VP preclinical for PanGenetics BV and Tanox. Louis is an author of over 360 publications in international scientific journals in the field of medical
biotechnology and an inventor at more than 20 patent applications.

Since 2021 Florian Capito is heading a group of downstream laboratories within the Microbial Platform, Sanofi Frankfurt site at Sanofi-Aventis Deutschland GmbH.
Together with his teams, he is developing DSP processes for early clinical projects as well as for commercial processes, focusing on SYNTHORINE™ molecules, NANOBODY® molecules and other novel protein formats.
Before working on microbial processes, Florian was acting as section head and lab head in the purification process development of mammalian processes, also successfully implementing continuous chromatography for GMP processes.Florian brings expertise in Process Analytical Technology, continuous chromatography as well as process characterization under GMP conditions from previous positions at Sandoz Austria and Merck KGaA.
He is a protein chemist by training, with a PhD focusing on selective protein precipitation.

Abstract

Here we describe how we successfully implemented continuous chromatography at Sanofi Frankfurt, both in development labs but also in GMP clinical trial manufacturing.This allowed reducing resin costs for the expensive protein A capture chromatography step by 70-95%, while maintaining quality targets. Additionally, it supported our eco-design goals, leveraging the entire protein A resin lifetime. Compared to traditional batch chromatography, the implementation of continuous chromatography requires a more careful process transfer, using a design space for residence time ranges, load ratio, flow rates of loading versus non-loading steps and overall process duration. We also describe how we developed approaches for performing virus clearance studies, mimicking the multi-column approach of continuous chromatography at a CRO.The talk concludes with currently considered scenarios for continuous chromatography, both for mAbs but also NANOBODY® molecules, and gives an outlook on the future Strategy of SANOFI regarding continuous chromatography and continuous processes

Uwe Gottschalk is an Operating Partner at Keensight.

Uwe has more than 30 years of experience within the field of bioprocessing and enzyme purification technologies.

He was CSO (Chief Scientific Officer) and CTO (Chief Technical Officer) of Lonza Pharma, a world leader in Life Sciences headquartered in Switzerland, from 2014 to 2021, where he focused on downstream bioprocesses.

Prior to Lonza, he was successively Vice President in Purification Technologies (2001-2009) and Group Vice President (2009-2014) of Sartorius, a leading international partner of life science research and the biopharmaceutical industry, listed on the German DAX stock market.

A German national, Uwe holds a Ph.D in Chemistry from the University of Münster.

Bas studied chemistry with specializations in bio-organic and biochemistry and obtained his Ph.D. in biochemistry from Nijmegen University. In 2001 he joined MSD, specializing in the field of protein formulation and protein and small molecule analysis. He switched to the department of downstream processing in 2006 working on the development of purification processes for proteins produced by prokaryotic and eukaryotic systems. Since February 2010, he is employed at Byondis as a principal scientist in downstream processing, working on all aspects of development of monoclonal antibodies and Antibody-Drug Conjugates, up to process validation and BLA writing. He is currently managing the downstream process development with a focus on early-stage process development, including tech transfer to large-scale manufacturing.

Abstract

A study was performed on the suitability of placing virus filters more downstream in the purification process. This has the benefit of further reducing the risk of contamination of a process intermediate by adventitious viruses, while also reducing the volume to be filtered due to the higher mAb concentration present in the (pre-)formulation buffer. The Byondis platform employs Planova filters and the currently used 15N filter was compared to the new selection of filters, i.e. BioEx, S20N and FG-1 offered by Planova. Several mAbs were selected and a comparison was made of the virus filter step between the usual location halfway the purification process and after polishing.Results showed that process performance at the usual place was quite similar for all mAbs tested, while the performance of the position after the polishing step was quite dependent on the mAb tested. Regardless of the position, the viral clearance was excellent with an effective removal found for all conditions tested.