CMC Analytical Comparability: Methods & Strategies for Biologics, Biosimilars & Biobetters

Venue: Vienna

Location: Vienna, Austria

Event Date/Time: Sep 10, 2012 End Date/Time: Sep 11, 2012
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Biologics, Biosimilars and Biobetters are considered the growth engine of the pharmaceutical industry. Currently the global market for biologics presents more than $ 130 billion. By 2016, the eight out of the ten blockbuster drugs will go off patent opening up the doors for generics and biosimilars. Becoming a steadily growing new field of biopharmaceutical development and bringing along safety and efficiency challenges, Fleming Europe has organized the CMC Analytical Comparability: Methods & Strategies for Biologics, Biosimilars & Biobetters.

Vice Presidents, Directors, Heads, Managers and Scientists involved in:

Biologics, Biosimilars, Biobetters, Copy Biologics, Biopharmaceuticals, Biotechnology, Biotherapeutics, Analytical Science, Process Science, Research & Development, Regulatory Compliance, New Product Development, Quality Assurance, Quality Control, Intellectual Property, Clinical Immunology, Scientific Affairs, Business Development, Portfolio Planning, Commercial Affairs, Legal Affairs, Pharmacovigilance, Branded and Generic Drug, Pharmaceuticals & Biotechnology Companies, CROs/CMOs, Drug Regulators, Academic & Government Bodies

The 2-day MasterClass will
Highlights the regulatory, scientific and technical challenges and opportunities involved
Provides an opportunity to learn the dos and the don’ts from the experts in this field
Represents a platform to discuss development challenges, technical hurdles, and regulatory expectations associated with Quality by Design and CMC characterization / comparability studies
Introduces state-of-the art analytical methods and concepts (analytical characterization of biosimilars and reference product, quality target product profile, aceptable range of variability, justification of differences)
Presents case studies of originator biologics and biosimilar products including examples addressing the development of biosimilar monoclonal antibody products
Provides insight into the latest regulatory requirements and technical aspects for successful development and analytical comparability/similarity studies