Candidates for 2016 ERP of the Year

EXPERT REVIEW PANEL, METHOD BACKGROUND, AND CONCLUSIONS

Criteria for Vetting Methods to be considered:

AOAC convened the

Official Methods of Analysis

(OMA) Expert Review Panel for Microbiology for Foods and

Environmental Surfaces on Wednesday, December 10, 2014 from 1:00pm to 5:00pm at AOAC INTERNATIONAL

Headquarters located at 2275 Research Blvd, Rockville, Maryland 20850.

The purpose of the meeting was to review and evaluate OMAMAN-19: R-Biopharm, Competitive Enzyme

Immunoassay Based on the R5 Monoclonal Antibody to Determine Partially Hydrolysed Gluten in Foods

Containing Wheat, Rye, and Barley. The co-study directors were Dr. Markus Lacorn from R-Biopharm AG, located

at An der neuen Bergstraße 17, 64297 Darmstadt, Germany and Patricia Meinhardt of R-Biopharm Inc. located

at 870 Vossbrink Drive, Washington, MO 63090.

The candidate method was reviewed and supplemental information was also provided to the reviewers which

included the collaborative study manuscript, method safety checklist, MSDS Conjugate, MSDS Sample Dilute,

MSDS Standard, AACC Published Article (includes protocol), and In House Validation report, and the package

insert.

Criteria for Vetting Experts and Selection Process:

The following eight (8) candidates and one (1) alternate member were submitted for consideration by the

Official Methods Board to evaluate candidate methods for food allergens (gluten) as per the Expert Review

Panel (ERP) Policies and Procedures. The following candidates are highly recommended by the Food Allergens

Community and other Food Allergen experts. Many of the following candidates have participated in various

AOAC activities, including but limited to, members of Committee H, and expert reviewers for the AOAC Research

Institute’s PTM Program. The members are Shang Jing Pan (Chair), Sneh Bhandari, Joe Boison, Eric Garber/

Girdhari Sharma (Alternate), Terrence Koerner, Todd Marrow, Bert Popping, and Paul Wehling.

ERP Orientation:

The ERP members have completed the mandatory AOAC Expert Review Panel Orientation Webinar on

Wednesday, November 5, 2014.

Expert Review Panel Meeting Quorum

The meeting of the Expert Review Panel was held in person. A quorum is the presence of seven (7) members or

2/3 of the total vetted ERP, whichever is greater. Five (5) out of the eight (8) voting members were present and

therefore did not met a quorum to conduct the meeting and present a vote. It was also noted that Bert Popping,

who was not present, will not participate on this Expert Review Panel until after March 2015.

Standard Method Performance Requirements (SMPRs):

N/A

Conclusion:

The Expert Review Panel reviewed OMAMAN-19: R-Biopharm, Competitive Enzyme Immunoassay Based On The

R5 Monoclonal Antibody To Determine Partially Hydrolysed Gluten In Foods Containing Wheat, Rye, And Barley

and request recommended changes, clarifications and/or revisions to the manuscript during the meeting. This

information is noted in the meeting minutes.

Subsequent ERP Activities:

A follow-up teleconference is scheduled for Tuesday, December 16, 2014 at 11:00am EST. The purpose will be to

review the revised edits and present a vote of the method as long as a quorum is present.

ERP PROFILE SUMMARIES

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