SOURCE: IBC Life Sciences

February 20, 2008 08:30 ET

IBC's Third Annual BioProcess International Analytical and Quality Summit

WESTBOROUGH, MA--(Marketwire - February 20, 2008) - IBC's Third Annual BioProcess International Analytical and Quality Summit is to take place June 2-4, 2008 at the Hyatt Regency in Cambridge, Massachusetts. This event consists of three separate conferences entitled Analytical Method Validation, Biophysical Analysis for Bioprocessing, and Process Characterization and Control. Attendees will receive materials and are able to attend any sessions from the three events.

Keynote Presentations for all three conferences:

--  Interdependence of Product Characterization, Analytical Method
    Validation, and Comparability Assessment
    Chulani Karunatilake, Ph.D. Director, Analytical Sciences Amgen, Inc.
--  Applying Quality by Design Principles to Assay Development and
    Dieter Schmalzing, Ph.D. Associate Director Genentech, Inc.
--  New Methods for Characterization of Protein Aggregation
    Tudor Arvinte, Ph.D. Professor, Department of Pharmaceutics and
    Biopharmaceutics, School of Pharmacy University of Geneva, Switzerland
--  The Application of Novel Biophysical Methods for Drug Development
    Jun Liu, Ph.D. Senior Scientist, Genentech, Inc.
--  Quality by Design in Biotechnology: Why and How?
    Wassim Nashabeh, Ph.D. Director, CMC Regulatory Affairs Genentech,
--  Application of QbD for Development and Manufacturing of a
    Rohin Mhatre, Ph.D. Director, Bioprocess Development Biogen Idec,

IBC's 4th Annual Analytical Method Validation gives assay development and validation scientists an indication of how qualification and validation activities are performed across the industry. Focus will be on timing and resource allocation at each step, updates on key regulatory and standards initiatives and optimizing method transfers.

The Second Annual Biophysical Analysis for Bioprocessing, will feature problemsolving case studies of the characterization of product variances, proteins for liquid formulations and MAbs from different cell lines as well as recent progress in biophysical methods for product analysis and characterization, with emphasis on AUC, FFF and image-based methods.

IBC's 5th Annual Process Quality Forum Process Characterization and Control is an event more broadly focused on the use of process characterization and control to biologics manufacturing. The meeting will reinforce manufacturing quality concepts being promoted by the USFDA in its "Quality Systems Approach" guidance (September 2006); ICH (International Council on Harmonization) guidances Q8 (Pharmaceutical Development), Q9 (Risk Management) and Q10 (Quality Management); and the US and EU Pharmacopoeias.

For up-to-date information and to register for this event, visit

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Contact Information

  • Contact:
    Kerry Patterson
    IBC Life Sciences
    (508) 614-1423
    Email Contact