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.