Pre-conference workshops:
Workshop 1
Sunday, November 5, 2023
9:30 am – 11:00 am
Magnetic separation in downstream processing
Sonja Berensmeier (TU Munich, Germany)
Sebastian Schwaminger (MedUni Graz, Austria)
The separation of proteins and nucleic acids by means of magnetic separation is becoming increasingly important on a preparative scale. Especially cell separation and magnetic beads for protein and polynucleotide separation are the gold standard in academic labs. The great benefit of these beads is the simple handling which allows for one step processes in the purification of biomolecules. This increases the yield and reduces the costs as centrifugation, chromatography or filtration steps can be avoided.
Despite its high potential, today’s biochemical engineers are, for the most part, wholly unfamiliar with the topics of magnetism and magnetic separations, and are thus unable to recognise areas within bioprocessing where magnetically driven separations could be applied beneficially. Therefore, starting from physical concepts we shall describe the development of arguably the most powerful magnetic technique for bioprocessing, i.e. High Gradient Magnetic Separation (HGMS). Using case examples, we shall illustrate the applications of magnetic separation alongside with the processing technology which is necessary for the design of separators on small and large scale. The properties required for magnetic separators suitable for biotechnology, the ways in which HGMS processes can be operated, modelled and optimised, and finally identify the technique’s future prospects within the bioprocess industries.
The workshop is divided into two main topics. First, an overview of the particle systems used and important parameters for their use in various applications will be given. Second, different magnetic separators, their operation and their performance for different case studies will be presented.
Workshop 2
Sunday, November 5, 2023
11:15 am – 12:45 pm
Bioinformatics as a tool developing robust biotherapeutic proteins
In silico predictions in the bioinformatics field is becoming more important for the development of new biopharmaceutical proteins preventing any issues with e.g. stability, aggregation, non-human sequences. Using in silico predictions in the early stage development of new biopharmaceutical proteins (e.g. monoclonal antibodies) would develop proteins that could overcome most of these issues and preventing delays during process development and clinical phase I studies.
By testing protein sequences in silico (e.g. structure, posttranslational modifications, aggregation, non-human sequences) anomalies can be found by comparing with databases and information based literature to find mistakes during in silico screening before starting process development work in the lab.
In this workshop example(s) will be given how to detect any anomalies in protein sequences that might affect the process development of the selected biopharmaceutical protein(s).
Workshop 3
Sunday, November 5, 2023
1:00 pm – 2:30 pm
Mechanistic understanding of biomolecules adsorption: theory and applications
A. Jungbauer (BOKU, Austria)
The request for mechanistic understanding of processes has completely changed the paradigm of process development and process validation in biopharmaceutical manufacturing. For chromatographic separation processes the equilibrium binding conditions, also referred to as adsorption isotherms, are important to get a theoretical understanding on the maximum possible binding capacity and are the basis for mathematical description of the separation processes. In this pre-conference workshop, we will provide the theoretical basis and the state-of-the-art in experimental approaches to monitor biomolecule – surface interactions in order to better understand equilibrium binding conditions. The participants will be offered an overview of different techniques: conventional adsorption measurements with finite and infinite bath, fluorescence assays, Attenuated Total Reflectance Infrared Spectroscopy (ATR-FTIR), Differential Scanning Calorimetry (DSC), Isothermal Titration Calorimetry (ITC), Flow Microcalorimetry (FMC) and Small Angle X-ray scattering (SAX). Specific advantages and drawbacks for each of the techniques to shed light on biomolecule mechanism of adsorption will be discussed. Focus will be put on FMC and SAX, as two non-labeling techniques capable of simulating a dynamic chromatography system allowing online and in situ monitoring of the adsorptive process. Finally, we will cover present applications of these in situ monitoring techniques to better understand antibodies, peptides and polynucleotides separation by different types of chromatography highlighting current challenges as well as future opportunities.
Workshop 4
Sunday, November 5, 2023
2:45 pm – 4:15 pm
Poly-/Oligonucleotide separation in biopharmaceutical processing and their quality requirements
Michel Eppink (Byondis, The Netherlands)
Egbert Müller (Tosoh Bioscience, Germany)
Oligo- und Polynucleotide-based therapeutics such as single-stranded antisense siRNA and mRNA or double-stranded DNA plasmids have been investigated over the last decades and their promise as a new drug modality is now being realized. There has been tremendous development since the first antisense approach in living cells in 1978. The growing interest in nucleotide-based therapeutics is driven by the high potential of the treatments of a variety of medical conditions, the growing number of FDA-approved oligonucleotide drugs, and an increased focus on personalized medicine and on the development of therapies for rare diseases. The increased demand for nucleotide-based therapeutics requires a cost-effective and easy scale-up from research amounts to commercial needs. For separation, chromatographic methods and other non-conventional methods are discussed, whereby the different production processes have a significant impact. Moreover, from a quality perspective, the regulatory requirements will be discussed during the development of an oligonucleotide trajectory towards a commercial product.
Key Note Speakers:
Elena Dominguez Vega
Dan Bracewell
Professor of Bioprocess Analysis, Department of Biochemical Engineering, University College London
