SC13: Sub Visible Protein Particles in Immunogenicity: Measurement, Characterization and Impact
Instructors:
Björn Boll, PhD, Head, Particle Lab and Higher Order Structure Protein Analytics, Physical Chemical Analytics, Novartis Pharma AG
Anacelia Ríos Quiroz, PhD, Scientist. Group Leader Particle Lab, Pharma Technical Development Europe (Biologics) Analytics (PTDE-A), F. Hoffmann-La Roche Ltd
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.
Anacelia Ríos Quiroz, PhD, Scientist. Group Leader Particle Lab, Pharma Technical Development Europe (Biologics) Analytics (PTDE-A), F. Hoffmann-La Roche Ltd
Anacelia Ríos Quiroz did her University studies as Industrial Pharmaceutical Chemist in the Polytechnic National Institute (IPN) of Mexico City. Afterwards, she did her Master studies in Pharmacology in the Centre of Research and Advanced Studies (CINVESTAV-Mexico City) on the field of Bioinorganic Chemistry. In 2012, she started her PhD studies in Pharmaceutical Technology in collaboration with Basel University and F. Hoffmann-La Roche Ltd., in Switzerland. She worked in the field of sub visible protein particles and has become an expert on particle counting characterization techniques. Her research increased the understanding on the applicability of emerging technologies as analytical tools for the pharmaceutical industry and serve as guideline for the implementation of related analytical methods. After a Post Doc in the field of evaluation of the immunogenicity of protein particles, she joined in January 2016 the Analytical Department of Roche where she leads the Particle Lab unit.