Webinar: Sub-Visible and Sub-Micrometer Particles in Biopharmaceutical Development

Date: 05 Apr 2017 Location: Online Event City: Online Event Country: Online Event

Characterization of sub-visible particles is a perpetually "hot" topic in biopharmaceutical development and recent increased interest from regulators has heightened its importance. Rapid development of sub-visible particle analytical technology has opened up significant new opportunities for particle characterization including various techniques for sub-micrometer particle measurements. However, it is still unclear if the analytical performance of these techniques can match those of conventional analytical methods. Another factor to consider is the increase in the requirements by Health Authorities and requests for submission of extensive characterization datasets and/ or assessments with regard to expansion of particle control strategies.

 

This webinar will provide a critical review of available and emerging sub-visible particle characterization technologies, including the advantages and shortcomings of each. The potential applications of individual methods to specific questions which may arise during the development process will be discussed in the context of the larger question of how to build a thorough, phase-appropriate particle characterization and control strategy.

 

Speaker

Dr. Atanas Koulov  

Dr. Atanas Koulov, Head Drug Product Analytical Development and Quality Control, Lonza Drug Product Services

Atanas Koulov has extensive experience in drug product analytical development and quality control release and stability testing, as well as characterization, investigations support and specification setting. His eight years of industry experience include managing Roche’s Particle lab, activities for visible, subvisible and submicron particles as well as responsibility for various programs in Analytical Development & QC of Drug Products. Prior to joining Roche, Atanas also worked as a Lab Head, Analytical Development at Novartis Biologics.

 

Atanas has published extensively in the field of protein aggregation and particles and is the immediate past chair of the AAPS Protein Aggregation & Biological Consequences Focus Group. He holds a Ph.D. in Biochemistry from the University of Notre Dame, IN (USA), earned his M.Sc. in Molecular Biology and Clinical Chemistry from Sofia University (BG) and worked as Postdoctoral Fellow at the Scripps Research Institute in San Diego, CA (USA).

 

Hosted in conjunction with the American Association of Pharmaceutical Scientists (AAPS), this webinar is scheduled for Wednesday, April 5 at 12:30 pm EDT.

 

Register Here

 

*All attendees must have an AAPS account in order to register. If you do not have an account with AAPS, please click here to sign up.

 

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