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. 

Premium Lecture

Joris van de Velde

Senior Application Engineer at Separation and Purification Sciences Division at 3M

Transition to Next Gen Downstream Processing with Single Use Polishing AEX Membrane Chromatography

Utilisation of a new guanidinium-ligand allows replacing resin-based AEX chromatography columns by compact single-use capsules. 
This technology overcomes many of the current downstream challenges by offering robust HCP, DNA and viral clearance in a wide range of pH, conductivity and buffers, while ensuring excellent target protein recoveries. 
Topics covered in this session include:
-    Single use AEX chromatography
-    Host cell Protein and Host cell DNA clearance
-    Viral clearance
-    Downstream process optimization and intensification

Parallel session 1

Nico Oosterhuis

Director Technology at Celltainer Biotech

Single-use bioreactors for cellular agriculture application

Cellular agriculture is a relatively new field of bioprocessing. Cultivation of mammalian-, plant- and insect cells is known and applied over decades already, but their use is limited to production of mostly biopharmaceuticals. Since the introduction of the “cultured meat burger” by Mosa Meat BV in 2013, many attempts are currently being carried out to produce cultured meat on an economical way. 
Application of plant cells to produce secondary metabolites, cacao products or cultivating somatic embryonic plant cells for growing trees, becomes more important and feasible.
Single-use bioreactors developed for the production of biopharmaceuticals can serve as a basis for a dedicated bioreactor design for such products as well. These reactor types may not fully address the capacity need of cellular agricultural products, though, by choosing a scale-out approach, single-use bioreactors, due to their flexibility, can contribute to get cellular agricultural production feasible. 
Developing systems for cellular agriculture, will require more than adopting the stirred tank reactors that are commonly used for mammalian cells, and that more sophisticated reactor designs are likely to be needed to achieve optimal conditions and minimal cost of goods.
 

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

Geoffrey Esteban

General Manager at IPRASENSE

Integrated High Throughput cell counting and viability analysis on your parallel micro bioreactors

Parallel session 2

Jort Altenburg

PhD Candidate at Wageningen University

Rapid process development using single-use technologies for the production of SARS-CoV-2 spike proteins

To control the pandemic SARS-CoV-2 outbreak, rapid development of a COVID-19 vaccine is needed as well as serological tests to determine whether or not someone has contracted the virus and has built up immunity. The baculovirus-insect cell expression system can be used to produce the SARS-CoV-2 spike protein for vaccine and serological test applications. To produce sufficient amounts of spike protein in a relatively short period of time, rapid screening for optimal process conditions is of utmost importance.
The Laboratory of Virology and the Bioprocess Engineering Group of Wageningen University started with screening different conditions for optimal cell growth and protein production in Sf9 cells using a multi well microscale bioreactor system (Micromatrix, Applikon Biotechnology, Delft, NL). This microscale stirred reactor system permits simultaneously performing 24 individual cultivations in a deep well plate format with control of DO, temperature, and pH. Optimal conditions were checked in 500 ml stirred tank bioreactor systems (Applikon Biotechnology, Delft, NL) and then scaled up to a 20 liter bioreactor to produce sufficient material for pre-clinical animal trials and serological testing.

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.

Parallel session 3

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.  

Ir. Philippe Herman

Project 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 4

Neil Ross

Senior Global Marketing Manager 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.