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Northeast Regional Forum May 2018
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Wednesday, May 2, 2018

Biogen - Building 9
300 Binney Street
Cambridge, MA 02142




Assessment of Criticality of Quality Attributes for Biotherapeutics


The Northeast Regional Forum is committed to bringing job-relevant education to the local biopharmaceutical and biotechnology community. These programs are dedicated to facilitating the sharing of information and best practices in order to advance scientific knowledge across industry, academia, and regulatory agencies. This full day program will feature presentations on the assessment of criticality of quality attributes for biotherapeutics, an interactive panel discussion, roundtable discussions, and opportunities to network with peers.



Learning Objectives:

1. Discuss guidelines and expectations for assessment of CQA with industry and FDA colleagues.
2. Learn industry best practices for assessment of CQAs. Key areas of focus will include:
    a. Criticality assessments for novel products such as live biotherapeutics vs. traditional molecules such as monoclonal                        antibodies
    b. CQA assessment and implementation of specifications, early stage vs late stage
    c. Comparison of CQAs for novel products vs. biosimilars
    d. Management of low abundance CQAs
    e. Strategies for assessing potency, PK/PD, immunogenicity, and safety in support of quality attribute criticality assessments
    f.  Analytical methods and appropriateness of methods used for the assessment of CQA (release vs. characterization)
    g. Role of forced degradation studies in determination of CQAs
    h. Application of platform vs. product-specific attribute knowledge in CQA assessments
    i.  Strategy for presentation of CQAs in regulatory filings – IND/IMPD vs. BLA/MAA



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