The development of a successful therapeutic drug requires thorough characterization of its shelf-life, which is crucial to ensuring correct dosage and patient safety. To optimize a drug’s shelf-life, various factors that contribute to its degradation must be detected and controlled so that its stability, potency and safety are not compromised.
Overview
The degradation of pharmaceutical products often involves the presence of impurities in the form of free radicals and transition metals. Electron Paramagnetic Resonance (EPR) spectroscopy is the only technique available that can directly and non-invasively detect these impurities. In this webinar, applications scientists Kalina Ranguelova and Ralph Weber from Bruker BioSpin will discuss the use of EPR in the detection of drug impurity, degradation and reaction monitoring.
EPR is 1000 times more sensitive than NMR. By analyzing an EPR signal, the user can identify, quantify and monitor temporal behavior of the impurities at extremely low levels - down to parts per billion.
Speakers
Dr. Kalina Ranguelova
Senior EPR Applications Scientist, Bruker BioSpin
Dr. Kalina Ranguelova is an EPR Applications Scientist in Bruker BioSpin Corporation since 2011. She completed her Ph.D. at The Bulgarian Academy of Sciences where she received a Ph.D. with research focused on inorganic copper complexes structure using electron paramagnetic resonance (EPR) spectroscopy. After two research positions at CUNY and National Institute for Environmental Sciences where she studied free radical biology and EPR spin trapping as method for measurement of reactive oxygen species (ROS), she joined Bruker and holds a role as Applications Scientist. Her current focus is detection and identification of free radicals in biological systems and pharmaceuticals using spin traps and spin probes. She has publications in journals like Journal of Biological Chemistry, Biochemistry, Free radical Biology and Medicine, etc. She has presented in many international meetings related to free radical research in biology and protein chemistry.
Dr. Ralph Weber
Senior EPR Applications Scientist, Bruker BioSpin
Dr. Ralph Weber started his scientific training at Brown University where he received a B.A in Chemistry and German Literature and Language. He continued his training at the University of Chicago, earning a Ph.D. in chemistry focusing on EPR and ENDOR studies of proteins and lanthanide complexes. Two postdoctoral positions followed. At Leiden University in the Netherlands he studied excited states of molecules using ODMR (Optically Detected Magnetic Resonance) and designed and constructed a high frequency pulse EPR spectrometer. At MIT he studied motional dynamics in lipids via solid state NMR and was one of the original project members to design and construct a DNP (Dynamic Nuclear Polarization) spectrometer incorporating a high power gyrotron. He joined Bruker 29 years ago in 1989. He is responsible for much of the documentation for EPR and also offers customer support for pulse, high frequency, and imaging applications. He is currently co-principal investigator on a five-year NIH grant to develop pre-clinical EPR imaging technology and to promote its use in the pharmaceutical industry.
What to Expect?
The speakers will introduce Bruker’s EMXnano bench-top EPR spectrometer package, which features the following capabilities:
- Determines cause and extent of degradation using just a tiny sample amount
- SpinCount tool quantifies impurity level and whether further purification is required
- Accommodates room-temperature between 100 and 425 K
- Photochemistry and photooxidation experiments
- Quantifies free radical concentration following sterilization
- Reaction monitoring
Who Should Attend?
- General managers involved in quality control and R&D related to drug degradation
- Academics who collaborate with pharmaceutical companies to develop drugs and optimize reaction conditions
- Researchers who study therapeutic proteins and reactive oxygen species in animals as part of drug development