Call For USP Monoclonal Antibodies Round Robin Study Participation

USP <129> Quality Attributes of Therapeutic Monoclonal Antibodies

Study Details

U.S. Pharmacopeia (USP) invites stakeholders, especially monoclonal antibody innovators and manufacturers, to participate in evaluating and setting standards for a newly developed USP general chapter <129> Quality Attributes of Therapeutic Monoclonal Antibodies. The chapter defines and recommends accepted methods and reference standards for quality control of monoclonal antibody drug substance. The purpose of this study is to widely disseminate size variant and capillary electrophoresis purity methods from the chapter to industry and other stakeholders to seek feedback on the performance of the methods and to solicit the stakeholder generated of batch data using the chapter <129> methods, allowing USP to assess the method suitability across the industry and set meaningful specifications based on industry batch data. Each participant is encouraged to test as many monoclonal antibody drug substance batches as possible, preferably 5 or more from each product.

The following sample selection criteria are provided to assist participants with identifying suitable test articles. Appropriate monoclonal antibody drug substance samples include material derived from: commercial manufactured lots or development, engineering, demonstration and clinical trial GMP (pilot or full scale) batches provided they are representative of the intended commercial process and run with parameters set at target values. Nonclinical batches are acceptable provided the material manufactured is representative of a commercial process. Test articles manufactured as part of process development/characterization (e.g., derived from design of experiments) with parameters intentionally manipulated to evaluate impact on quality attributes are considered unsuitable for the round robin study. The test articles chosen should be representative of the spectrum of clinical product including product stored at the intended storage condition and close to but not exceeding expiry.

This study is sponsored by USP Recombinant Therapeutic Monoclonal Antibodies Expert Panel which will review submitted information and batch data generated from the study. All submitted information and batch data will be treated confidentially. Batch data will be blinded to safeguard the identity of participants. Based on the information and batch data received, the USP Recombinant Therapeutic Monoclonal Antibodies Expert Panel will recommend specifications related to size variant and capillary electrophoresis purity methods for approval by the General Chapters Biological Analysis Expert Committee prior to publication in USP Pharmacopeial Forum.

Candidates interested in participating in the study are encouraged to contact Dr. Anita Szajek (aey@usp.org ) no later than Tuesday January 31, 2012. If you are selected to participate in the study, you will receive information necessary to conduct the laboratory work and material intended for method system suitability purposes. USP appreciates your continuing support in setting public standards.

Deadlines:

RSVP to call for Study Participation: Tuesday January 31, 201

Deadline for Participants to submit full data package: April 30, 2012

SOURCE: U.S. Pharmacopeia