E8-16459. Rapid Methods for Detecting Mycoplasma Contamination in the Manufacture of Vaccines, Including Pandemic Influenza Vaccines, and Other Biological Products; Public Workshop

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

The Food and Drug Administration (FDA) is announcing a public workshop entitled “Rapid Methods for Detecting Mycoplasma Contamination in the Manufacture of Vaccines, Including Pandemic Influenza Vaccines, and Other Biological Products.” The purpose of the public workshop is to provide a forum on recent scientific and technical achievements in the development of rapid methods for mycoplasma testing during the manufacture of vaccines and other biological products. Such discussion may help to assess how these methods compare with currently used methods. Expedited manufacture may be of particular importance to public health during an influenza pandemic.

Date and Time: The public workshop will be held on September 22, 2008, from 8:30 a.m. to 5 p.m., and September 23, 2008, from 8:30 a.m. to 12 noon.

Location: The public workshop will be held at the Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877.

Contact Person: Bernadette Kawaley, Center for Biologics Evaluation and Research (HFM-43), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-2000, FAX: [phone], e-mail: [e-mail] (Subject line: Mycoplasma Workshop).

Registration: Mail, fax, or e-mail your registration information (including name, title, firm name, address, telephone and fax numbers) to the contact person by August 22, 2008. There is no registration fee for the public workshop. Early registration is recommended because seating is limited. There will be no onsite registration.

If you need special accommodations due to a disability, please contact Bernadette Kawaley (see Contact Person) at least 7 days in advance.

Submit written abstracts to the contact person by August 15, 2008 (see section II of this document for additional information).

SUPPLEMENTARY INFORMATION:

I. Background

FDA will explore the use of alternative methods for detecting mycoplasma contamination in the manufacture of vaccines, including pandemic influenza vaccines, and other biological products. Alternative methods that allow detection of mycoplasma in a shorter period, as compared to the current methods, could expedite the manufacture of vaccines and other biological products. The workshop is aimed at: (1) Identifying promising rapid method(s) for further validation to demonstrate equivalency or superiority to methods currently used for mycoplasma testing during the manufacture of vaccines and other biological products and (2) providing information that may lead to collaborative studies with FDA on testing for mycoplasma. The program agenda will be available at http://www.fda.gov/​cber/​scireg.htm, by September 5, 2008.

II. Submission of the Abstracts

For purposes of discussion at the workshop, FDA is requesting submission of abstracts that describe current developments in rapid methods for detection of mycoplasma contamination during manufacture of vaccines and other biological products. FDA will select a limited number of abstracts for formal presentation at the workshop by the abstract authors. If time permits, FDA may allow additional presentations from interested persons attending the meeting who did not submit an abstract. FDA will notify authors of abstracts accepted for presentation at the workshop by August 25, 2008.

Abstracts should be a maximum of 350 words, printed (typewritten or computer) and double-spaced. The title should be brief and capitalized. The authors name(s), contact information, and agency, institution, or facility involved should be listed. The author who intends to present the abstract should submit a current curriculum vitae with the abstract.

Dated: July 11, 2008.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.