Dr. Paul Beckett 

Senior Manager Downstream, BioContinuum^TM Platform – MERCK                                    

Title Lecture: Impact of intensified bioprocessing on sustainability

Summary: With the move of the biopharmaceutical manufacturing industry towards Biopharma 4.0 the focus has also been on increasing the efficiency and utility of such processes.  This has led to a drive towards continuous processing in the long term for processes where it is appropriate and an intensified bioprocessing approach to the others.  Whilst the economic impacts are well understood with such approaches there is limited data on how these new efficiencies contribute to sustainability metrics.  This lecture will provide an overview of the sustainability metrics commonly used, key sensitivities and a case study with a downstream intensified process.

About the speaker: Paul Beckett is a biochemical engineer who gained his masters and doctorate degrees at University College London in biochemical engineering.  He has worked in the biopharmaceutical industry for over 20 years in diverse roles such as chromatography resin R&D, GMP bioprocess operations and CMC regulatory affairs.  For the past 10 years he has worked as a technology consultant for Merck Life Science specialising in downstream purification and has recently taken on the role of managing the downstream portion of Merck’s next generation BioContinuum^TM bioprocessing platform.

 Final session

Marc Bisschops

Vice President MSAT – Pall Corporation                                

Title Lecture: Process Intensification - Monoclonal Antibodies and Viral Vectors

Summary:

The biopharmaceutical industry is undergoing rapid changes. Already before the pandemic, there was a drive to enhancing process efficiency and agility in manufacturing. The pandemic has put more emphasis on the ability to rapidly respond to market dynamics, for instance in vaccine manufacturing. These trends can be grouped under process intensification. In this presentation we will discuss how a more holistic perspective on process intensification can help the biopharmaceutical industry to address these challenges.

Within this framework, there is not a one solution that fits all. The needs for monoclonal antibody manufacturing are different than for gene therapy products. Process intensification targets to offer a toolbox of solutions that can be used to address the requirements for different segments of our industry.

About the speaker: Within Pall Biotech, Marc is responsible for the global MSAT support activities related to cell culture technologies, filtration technologies, single-use technologies and process intensification. In addition to this, he has been spearheading the development of the regulatory support initiative for process intensification and continuous bioprocessing within Pall Biotech.

Marc holds an MSc in chemical engineering and a PhD in biochemical engineering, both from Delft University of Technology (The Netherlands).

Within Pall Biotech, Marc is responsible for the global MSAT support activities related to cell culture technologies, filtration technologies, single-use technologies and process inte  nsification. In addition to this, he has been spearheading the development of the regulatory support initiative for process intensification and continuous bioprocessing within Pall Biotech.

Marc holds an MSc in chemical engineering and a PhD in biochemical engineering, both from Delft University of Technology (The Netherlands).

Parallel Sessions

Gerben Zijlstra

Sr. Platform Technology Consultant -   Sartorius Stedim Biotech

Title Lecture: Process intensification in the biopharma industry - Improving efficiency of protein manufacturing processes from development to production scale

Summary: Process intensification strives for more efficient conversion of raw materials into products while minimizing resource usage.

We present intensification techniques and process sequences that deliver synergistic benefits like increasing space-time yields, shortening production runs, or saving numerous days in cell expansion. Combining highly productive perfusion with continuous downstream purification promises improved yields and production economics, especially for advanced, often labile molecules. Since many techniques readily extend to other protein and viral vector based biotherapeutics, intensification can be regarded as key pillar enabling fast, cost-efficient development and production of biopharma products.

About the speaker: Gerben is a regular speaker on process intensification, process integration and continuous biomanufacturing. He received his Ph.D. from the University of Wageningen (The Netherlands) in the field of process integration in animal cell culture. He has worked for more than 20 years in the CDMO industry and has been involved in the development of several commercial Bio-therapeutics, as well as innovation projects. He was one of the early adopters of Single Use bioreactors and is the first inventor of the Concentrated Fed-Batch - XD® technology, amongst others licensed by Amgen. Subsequently, as a Consultant, Gerben has been working on several Continuous BioManufacturing as well as Gene Therapy projects. Since end of 2016 he has joined the Sartorius Stedim Biotech Marketing Team, where he currently holds a position as External Collaboration Manager for Intensified and Continuous BioManufacturing.

Mr Joszef Vasi

Senior Scientist R&D - Cytiva

Title Lecture: Scaling up an E. coli upstream process for plasmid DNA production

About the speaker: Dr. Vasi is currently Senior Scientist for Cytiva with primary focus on development and scale-up of microbial and mammalian cell cultivation processes for production of rec. proteins and plasmid DNA in both stainless steel and single-use bioreactors. Prior to Cytiva he held positions as upstream and midstream process developer in several biotech companies.
He has an MSc degree in Biotechnology from Technical University of Budapest and received his PhD in Microbiology from The Swedish University of Agricultural Sciences in 2000.

René Matt

Senior Key Account Manager Single Use Technology - Hamilton Bonaduz AG

Titel lecture: Single Use Sensor Technology  

Summary: Hamilton has adapted its trusted sensor technology to single-use environments, including solutions for pH, dissolved oxygen, conductivity, and viable cell density. Now available for bag manufacturers and other integrators.         

About the speaker: Mr. René Matt is senior account manager for Single use products and responsible for the integration process of all Hamilton SU Sensor solutions to the main bioreactor manufacturers and partners worldwide.

Edward Best

Global Regulatory Manager - Watson Marlow                                                                                                      

Title Lecture: X-ray Irradiation of SUT Products as an Alternative to Gamma

Ed Best is the Global Regulatory Manager at Watson-Marlow Fluid Technology Solutions (WMFTS).  Prior to joining Watson-Marlow, Ed held the position of R&D Manager at Thermo Fisher Scientific leading a team of chemists and microbiologists developing in vitro diagnostic devices.  He has a degree in Chemistry from the Newcastle University, UK and has pharmaceutical industry experience gained from working for Broughton Laboratories, a pharmaceutical analytical services laboratory in North Yorkshire, UK.

Keynotes

Gerben Zijlstra

Sr. Platform Technology Consultant at Sartorius Stedim Biotech

Process Intensification made “easy” by PAT and perfusion enabled bioreactor tools for rapid development and scale-up to commercial scale 

The Biopharma industry is challenged by costs pressures, increasing numbers of low volume products with unpredictable demand and the advent of new less stable molecules, like bi-and multi-specifics that may not always be suitable for production in the standard Fed-Batch platforms.
Flexible, Single-Use manufacturing plants, in combination with process intensification strategies, can deal with these multi-product, multi-modality portfolios and pipelines and are becoming a central part of biomanufacturers’ production infrastructure.
Process Intensification, including (partially) continuous manufacturing does require substantial efforts and new approaches in development and process control during manufacturing.   
This presentation will firstly highlight new options for perfusion compatible cell line development and high cell density cell banking. Subsequently, the advantages of perfusion process development by using high-throughput Ambr® perfusion and benchtop perfusion tools with integrated PAT tools will be discussed. Finally the benefits of advanced software tools for scale-up and advanced process control at commercial scale in perfusion and PAT enabled stirred tank and rocker bioreactors will be shared.

Kai Touw

Technical Lead a Batavia Biosciences

Adapting production platforms to accelerate vaccine availability

• The current pandemic and recent epidemics show the importance of accelerating vaccine development
• Several approaches have been demonstrated to be promising
• In this talk a combination of platform strategy and process intensification will be discussed

Louis Boon

Chief Scientific Officer at Polpharma Biologics

Use of single-use bioreactor in the development of biosimilar monoclonal antibodies

Single-use bioreactors are the cornerstones of the success of current biosimilar manufacturing, since it enables rapid process optimization, regional manufacturing and a 10-fold lower CAPEX to build such a facility. As an example the development of a biosimilar our nivolumab biosimilar for which we used our SPOT™ and SLIM™ technologies will be presented. Our process modulation toolbox was applied to specifically modify CQAs on nivolumab and the process was modulated to specifically increase or decrease specific glycan structures and the charged profile. The modulatory strategy does not limit productivity in out nivolumab process, delivers high producing biosimilar antibody processes of > 5 g/L, enabling to ultimately produce biosimilar nivolumab in a single-use facility at low COGs.
 
The developed modulation toolbox can also be used beyond biosimilars for novel biological entities. Since high terminal galactosylation can increase CDC effector function and low core-fucosylation improves ADCC effector function, the modulation toolbox can obviously also be used to optimize the anticipated biological effectiveness of a novel product. 

Parallel session 1

Rüdiger Göhmann

Product Group Manager Pharma & Chemicals at
GEA Westfalia Separator Group GmbH

GEA kytero – the first single use disc stack separator from GEA for mammalian cells and E.coli, reducing space requirements in the clean room substantially

Superbly efficient disc stack technology, based on world-renowned GEA Westfalia separation expertise and decades of industrial scale cell-harvesting solutions, is now available for the first time in a convenient click-&-produce unit for small production and fully scalable product development in the lab. Discover secure, efficient and clean separation with a new bowl concept! Test & Buy options can be offered.

Patrick Hoevenaars

Sales Manager Benelux, Continuous Monitoring Systems and Industrial Measurements at Vaisala Oyj

Humidity measurement in H2O2 bio-decontamination – Relative saturation as the key

• Basics of bio-decontamination with vaporized H2O2
• The importance of continious measurement during bio-decontamintaion
• Patented PEROXCAP technology
• The difference between Relative Humidity  (%RH) and Relative Saturation (RS%)
• Five most typical pitfalls in humidity measurement during bio-decontamination

Parallel session 2

Laura Vincent

Marketing & Sales at IPRASENSE

A breakthrough cell count and viability label-free method for HT cell culture monitoring in bioreactors

Geoffrey ESTEBAN, CEO of IPRASENSE presents today his automatic cell counters and viability analyzers product range: NORMA. One of the instruments, the NORMA 4S, is perfectly suited to high throughput parallel micro bioreactors for full automation! Come and learn more! 

Marijke Slabbinck

General manager at Ansers Analytical Services

Characterization and identification of particle and fibre contaminations in single-use devices

Particle and fibre contaminations can occur at multiple time stamps during manufacturing. Join our seminar to understand how we, at Ansers, characterise and identify the contaminations and offer solutions to manage and control them in single-use devices.

Parallel session 3

Frank Hopstaken

Team leader Bioprocessing at Cytiva

Intensified upstream operations with Xcellerex™ Automated Perfusion System (APS)

Designed to address your needs for flexibility, reliability, and simplicity in upstream perfusion applications, Xcellerex™ Automated Perfusion System (APS) is a new single-use system for both process development and production. Use this tangential flow filtration (TFF)-based system for intensified cGMP manufacture of preclinical and clinical material. Perform a variety of upstream applications including classic steady state and N-1 perfusion, as well as techniques using ultrafilters, by integrating this multifunctional system with XDR bioreactors.

David McCullough

Technical Application Manager Biopharma Production Solution at Avantor

Managing risk and minimizing the complexity of your global single-use supply chain
Single-use systems have been proven to enable a more flexible, cost-effective approach to manufacturing monoclonal antibodies (mAbs), cell and gene therapies, vaccines and other complex biologics. Single-use solutions can facilitate multi-product manufacturing in order to increase capacity and reduce cost. Regulatory, manufacturing and quality requirements for single-use products as well as the complexities of a global supply chain are fundamental challenges. In this presentation, learn why it’s important to adopt a global single use supply chain strategy as part of the early stages of a product lifecycle, with a case study demonstrating how innovative single-use solutions can both support supply chain security and enhance efficiencies in biopharma manufacturing processes.

Parallel session 4

Marcus Bayer

Market Segment Manager at Hamilton Bonaduz AG

New sensor technology for the future of bioprocessing in single-use

Measuring and controlling critical process parameters in single-use applications require modern sensing solutions, that are specifically designed to meet the requirements of a single-use production environment. For example, the use of insertion devices to adapt reusable process sensors into single-use systems is still widely spread. However these devices add cost and risk leakage and contamination.
Sensor expert Hamilton Process Analytics has worked closely together with single-use bag and bioreactor manufacturers to find ways how to overcome these shortcomings. This collaboration resulted in the development of pre-installed and pre-sterilized solutions, including unique components for ideal integration.

Marcus Bayer, Market Segment Manager and Single-Use Sensor expert at Hamilton Process Analytics provides an overview about the common pitfalls of measuring and controlling critical process parameters in single-use applications and explains the latest breed of process sensor solutions that eliminate the shortcomings, single-use bioproduction sites had to deal with in the past.

Ralph Daumke

Global Market Manager Life Science at Filtrox AG

Using Diatomaceous earth (DE) and FILTRODISC™ BIO SD for Biotechnology processes

The presentation will describe an economical, efficient and robust technology for clarification of fermentation broth and/or cell debris solutions for the production of e.g. mAb`s or plasmid DNA and viral vectors. By using Diatomaceous earth and FILTRODISC™ BIO SD it is possible to replace the centrifuge step and establish a fast and reliable single-use technology in the biotech process. FILTRODISC™ BIO SD is linear scalable from process development to production. The production scale fits to all common single-use connectors on the market and can be used as an integrator of different single-use systems.