Alexander Pitters
Kaiser Optical Systems, SARL, France
Title: Raman Spectroscopy as a Real-Time In Situ Sensor for BioPharma
Submitted Date: 16-11-2015
Biography
Alexander Pitters is a Life-Science Engineer (M.Sc. - University of Technology and Economics Berlin), worked at Max Planck Institute for Molecular Genetics in Berlin as a Biologic-Technical Assistant, at Procter&Gamble Brussels Innovation Centre as a Process Development Engineer, and at Bayer Technology Services in Berkeley as a PAT-Biologics Engineer. He joined Kaiser as an Applications Scientist to analyze data, create chemometric models and develop business within the pharmaceutical industry.
Abstract
Mammalian cell cultures are complex processes where cells are cultivated under highly controlled conditions using media with a very high number of components. Current effort is focused on obtaining a better understanding of mammalian cell cultures by cultivating predominantly CHO cells for therapeutic protein production. To ensure a healthy progression of the cell culture, it is important to understand and monitor the stages of the biologic manufacturing. rnrnIn order to build quality into a process a primary step is to analyze the process, understand what the critical quality attributes are, and monitor or rather control those factors. Consequently, there is a significant interest and value in techniques that provide instantaneous response for monitoring and analyzing biopharmaceutical processes. Molecular techniques - such as Raman spectroscopy - are widely used for PAT applications, because they provide in-situ information in real-time.rnrnRaman spectroscopy is a method by which multiple bioprocess assays can be measured in situ within the bioreactor or fermenter environment. Raman is a fundamental vibrational spectroscopic technique that provides chemical and physical information that can be used to generate multi-component qualitative and quantitative predictive models. rnrnReal-time measurements within Biopharma are achieved for Glucose, Glutamine, Glutamate, Lactate, Ammonium, Viable Cell Density, Total Cell Density, Osmolality, Monoclonal Antibodies and Viability.
Samer M. Al-Hulu
Al-Qasim Green University, Iraq
Title: Immunogenicity of Biosimilars
Submitted Date: 18-01-2016
Biography
Samer M. Al-Hulu, Assistant Professor of Microbiology, has completed his PhD at the age of 29 years from Babylon University/College of Science. He has published more than 14 papers in microbiology field. Al-Hulu, has training at Ministry of Health at Laboratory of Babylon Maternity and Children Hospital. Now working at Al-Qasim Green University/College of Food Science.
Abstract
A biosimilar is a biological medicinal product which is similar to authorized biological medicine (reference medicinal product).A biosimilar and its reference product are expected having the same safety ,efficiency profile, and are generally used for treating the same conditions. There are many factors which contributing to immunogenicity includes: The first, product related factors which include structural properties such as sequence for protein ,presence of exogenous or endogenous epitopes ,degree of glycosylation, exposure of antigenic sites and solubility, formulation and storage, downstream processing, impurity level or presence of contaminants, second, host related factors, such as the genetic predisposition of a patient may influence the production of neutralizing antibody, the genetic sequence that encoding for endogenous equivalent of the therapeutic protein, concomitant illnesses, such as kidney and liver diseases, which may influence on immunogenicity, and dose and route of administration. There are many methods for measuring of immunogenicity which includes: Radio immuno precipitation assay (RIPA),Direct ELISA (enzyme linked immunosorbant assay),Bridging ELISA, Electrochemical luminescence assay, and Surface Plasmon resonance.
