Pre Conference Event

Analytical Biotechnology:
Method Development & Validation
Prof. Ira Krull

18 January 2010
9:00 - 17:00
Lev Hakongressim, Weizmann Science Park, Golda Mair 5, Ness Ziona

The course will provide a description and summary of how to analyze for protein and peptide biopharmaceutical products, including the drug substance and drug product, emphasizing posttranslational modifications and impurities. We will also discuss commonly found protein variants and isoforms in biopharmaceutical products, and the currently accepted analytical methods, their development and validation. Current FDA requirements for protein biopharmaceuticals will also be explored and intensively discussed.

Benefits to the Participants

• Become more informed about the general field of analytical biotechnology, separation-detection, isolation and characterization of biopharmaceutical products, especially proteins, peptides and antibodies.
• Become more informed about automated methods development and validation, including computer controlled operations and software for protein and peptide separations, especially peptide mapping of recombinant proteins as drug substances.
• Learn about methods optimization guidelines, goals, and software available to develop and validate newer bioanalytical methods.
• Learn more about biopharmaceutical regulatory requirements, for both proprietary and biogeneric or biosimilar, protein and antibody drug products.
  

Issues to be covered

• Characterization of biopharmaceutical product variants (PTMs), as well as drug or process impurities in final products.
• Current biopharmaceutical regulatory science requirements for agency submittals.
• What is analytical biotechnology and how does it differ from conventional analytical chemistry and its methods for low MW pharmaceuticals.
• The steps and approaches needed in analytical method development for biopharmaceutical drug products.
• Newer analytical methods for biopharmaceuticals-proteins, peptides and antibodies.
• FDA requirements for analytical method validation and acceptance of biopharmaceuticals.
  

Who should attend

• Scientists, technicians and managers within the biopharmaceutical/biotechnology industries, already involved in developing new or improved biotechnology drug products.
• Graduate students interested in learning more about what is needed to successfully gain employment and advance in the biotechnology industry.
• Academic faculty and scientists involved in protein chemistry or biology, needing to better understand how to fully or partically characterize proteins, peptides and/or antibodies on a regular basis.
• Governmental regulatory agencies and their employees involved in overseeing the biotechnology industry, receiving new or improved drug applications and submittals, and reviewing CMCs on new drug products.
• Proposal reviewers within funding agencies who are responsible for reviewing and judging funding proposals involving biotechnology drug products, protein chemistry, protein-protein interactions, antibody purification and analysis, method development and validation protocols.

About the Speaker

Prof. Ira Krull
Professor Emeritus Krull has taught for >30 years at the university level, both undergraduate and graduate courses in the areas of: General Chemistry, Organic Chemistry, Instrumental Analysis, Analytical Chemistry/Biochemistry, Analytical Biotechnology, Forensic Science, and Biopharmaceutical Regulatory Science. He has published over 300 technical articles, mostly peer-reviewed, co-authored or edited several analytical texts, co-authored a column in LCGC Magazine on Validation Viewpoint (12 years), has presented over 500 scientific papers at meetings/conferences, has mentored dozens of undergraduate, graduate, Postdoctoral and Visiting Scientist students, and has consulted for almost 35 years for a large number of the major pharmaceutical, biopharmaceutical and instrumentation companies around the world. He has also taught training courses, such as this, to the public and private companies, dealing with analytical biotechnology, method development and validation for over 30 years.

Registration fees: 980 NIS+VAT

For registration form please click here