Vaccines, Blood & Biologics
Agenda - Rapid Methods for Detecting Mycoplasma Contamination in the Manufacture of Vaccines, Including Pandemic Influenza Vaccines, and Other Biological Products
Hilton Washington DC North/Gaithersburg
620 Perry Pkwy.
Gaithersburg, MD 20877
September 22, 2008, 8:30 a.m. to 5 p.m.
September 23, 2008, 8:30 a.m. to 12 noon
Workshop Chair: Rajesh K. Gupta, Ph.D., CBER
Ms. Christine Anderson, CBER
Dr. Kurt Brorson, CDER
Dr. Vladimir Chizhikov, CBER
Dr. Konstantin Chumakov, CBER
Dr. Rajesh K. Gupta, CBER
Dr. Arifa Khan, CBER
Dr. Philip Krause, CBER
|Day 1, September 22, 2008|
|8:30 a.m.||Welcome Remarks|
|8:40 a.m.||Introduction to Workshop
Rajesh K. Gupta, Ph.D., CBER
|8:50- 9:15 a.m.||Mycoplasma contamination of biologics: Regulatory aspects of the mycoplasma testing.
Vladimir Chizhikov, Ph.D., CBER.
|9:15-10:40 a.m.||PCR Mycoplasma assay according to EP Chapter 2.6.7.
Sven M. Deutschmann, Ph.D., Roche Diagnostics GmbH, Germany.
|9:40- 10:00 a.m.||Status of the PDA Technical Report for Alternative Mycoplasma Tests Methods
Kurt Brorson, Ph.D. CDER
|10:00 -10:20 a.m.||Break|
|Session 1. Direct NAT Methods
(Chairs Dr. Konstantin Chumakov and Dr. Arifa Khan)
|10:20 - 10:45 a.m.||Development and Validation of a Touchdown PCR method for the detection of Mycoplasma.
Barbara J. Potts, Ph.D., Genentech, Inc.
|10:45-11:10 a.m.||Detection of Mycoplasma/Acholeplasma contamination by amplification of specific nucleic acids and fluorescent probe technology.
Michael J. Hantman, Ph.D., Charles River
|11:10 - 11:35 a.m.||Design and development of a high-throughput platform for rapid Mycoplasma identification and automatic data management. "
Dr. Bjorn Breth, Greiner Bio-One GmbH
|11:35-12:00 p.m.||Effects of Mycoplasma Infection in Cell Culture Systems and development of a PCR-based assay for its detection.
Pranvera Ikonomi,Ph.D., American Type Culture Collection
|12:00- 1:00 p.m.||Lunch Break|
|1:00-1:25 p.m.||Detection of Mollicutes by a two-step RT-PCR method.
Gert Jan Haan, Ph.D., Centocor B.V.
Discussion (Topics to be covered)
|Session 2 NAT Methods Combined with Initial Enrichment Step
(Chairs Dr. Philip Krause and Dr. Vladimir Chizhikov)
|2:00-2:25 p.m.||Rapid Mycoplasma Testing: The HyMy TM Assay combines amplification of viable Mycoplasma in Broth Culture with signal detection by Quantitative Polymerase Chain Reaction (QPCR).
Jeri Ann Boose, Ph.D., BioReliance Corporation
|2:25-2:50 p.m.||Biological Enrichment of Mycoplasma Agents using Co-Cultivation with Permissive Cell Cultures.
Dmitriy V. Volokhov, Ph.D., CBER.
|2:50- 3:15 p.m.||Incorporation of an Alternative Detection Method reduces Mycoplasma testing time
Timothy A. Coleman, Ph.D., Lonza Bioscience
|3:40- 4:05 p.m.||Design, Development and Qualification of the MicroSEQ TM Mycoplasma Detection Assay.
Michael T. Brewer, Applied Biosystems Inc.
|4:05-4:30 p.m.||Rapid Mycoplasma detection coupling a novel sample preparation device to molecular methods.
Martha S. Rook, Ph.D., Millipore Corporation
Discussion (Topics to be covered)
|Day 2, September 23, 2008|
|Session 3: Comparative Evaluation of Rapid Methods and Other Practical Aspects in Developing Rapid Methods
(Chairs Dr. Kurt Brorson and Ms Christine Anderson)
|8:30-8:55 a.m.||Application of Risk-based approach to optimize a rapid Mycoplasma test for cell therapy and tissue-engineered products.
John Duguid, Genzyme
|8:55- 9:15 a.m.||NAT vs. Microbiological culture - comparing chalk with cheese?
Helena M. Windsor, Mycoplasma Experience
|9:15 - 9:30 a.m.||Discussion|
|9:30 - 10:00 a.m.||Break|
|Session 4: Panel Discussion on Selection of Promising Alternative Method(s) for Further Evaluation and Planning of Collaborative Study
(Chair Dr. Rajesh K. Gupta)
|10:00 - 10:10 a.m.||Introduction Remarks,
Rajesh K. Gupta, Ph.D.
|10:10 - 12:15 p.m.||Discussion (All speakers and members of committee as panel)|
|12:15 - 12:30 p.m.||Concluding Remarks and Plans for a Collaborative Study|
Other topics for Discussion