Sub Visible Protein Particles in Immunogenicity: Measurement, Characterization and Impact
THURSDAY, APRIL 11, 5:45 - 8:15 PM
Instructors:
Björn Boll, PhD, Head, Particle Lab and Higher Order Structure Protein Analytics, Physical Chemical Analytics, Novartis Pharma AG
Antonio Iglesias, PhD, Expert Scientist, Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche, Ltd. Basel
Course Description:
This interactive short course will give an overview on commercially available counting methodologies for detection of sub visible particles (aggregates between 0.02 and 50 um). These species, ubiquitously present in protein formulations, had been in focus due to immunogenicity and quality attributes of Biotechnological products. Thus, the analytical toolbox to characterize them undergoes constant renewals and innovations. Their applicability towards the assessment of a meaningful array for particle counting characterization will be discussed including examples of their use in the frame of immunogenicity studies.
Topics to be Covered:
- Current regulatory expectations
- Mechanisms behind formation of soluble aggregates and SVPs
- Potential biological impacts
- Overview of Aggregates
- Causes of aggregation
- How to assess sub-visible particle characterization
- Current concerns in the context of immunogenicity with examples
- Analytical toolbox: Particulate determination
- Advantages/ disadvantages of the introduced methods
- Technologies and tools for identification and characterization
- Latest analytical methods for aggregate detection
- Field flow fractionation, Micro Flow Imaging and newer technologies
- Comparisons between technologies regarding limits of detection
- Old challenges and newest improvements
Biographies:
Björn Boll, PhD, Head, Particle Lab and Higher Order Structure Protein Analytics, Physical Chemical Analytics, Novartis Pharma AG
Dr. Boll studied in Göttingen and received his PhD from the University of Tübingen in Germany focusing on purification and characterization of proteins of antibiotic biosynthesis. He afterwards performed studies of the biological consequences of sub-visible particles at the Analytical Development Department at Roche in Basel, Switzerland. After joining Merrimack Pharmaceuticals in the Boston area and driving the physical-chemical characterization of early phase projects, Dr. Boll is now heading the particle lab and higher order structure analytics at Novartis in Basel, Switzerland.
Antonio Iglesias, PhD, Expert Scientist, Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche, Ltd. Basel
Antonio Iglesias studied Biology in the Freie Universität, Berlin (Germany) where he completed his PhD in the Max-Planck-Institute for Molecular Genetics. He then turned into Immunology and worked between 1983 and 1985 in the Basel Institute for Immunology and worked with Nobel Laureate Georges Köhler. Ever since he made immunological research in the Max-Planck-Institutes in Freiburg (Immunobiology) and Munich (Neuroimmunology), Germany, for 18 years. Since 2002 in Roche Basel, he worked in the Transgenic Unit and in the Stem Cell Platform before joining Non-Clinical Safety (now Pharmacological Sciences) in May 2012. His research activities encompassed regulation of Immunoglobulin expression and B lymphocyte differentiation; Autoimmunity of the central nervous system (Multiple Sclerosis); Homologous recombination in pro- and eukaryotes; embryonic stem cells and iPSC technology and humanized animal models for the study of autoimmunity, tolerance and preclinical Immunosafety.