Understanding PCR and Mycoplasma Testing

LOCATION:Attend Live Webinar

DATE: 13-Dec-2016 : 1:00 PM EST

DURATION: 60 Mins


Speaker : Erika L. Roberts, M.F.S

Erika L. Roberts, M.F.S, is a Masters in Forensic Science (with an emphasis in document examination) and currently works as a Senior Quality Assurance Analyst and as a freelance consultant for the pharmaceutical/biotech industries. Having over more than a decade of experience working in many different areas of the pharmaceutical and biotech manufacturing quality environments, Ms. Roberts is uniquely qualified as a subject matter expert for sterility testing and microbial identification trainings. Her extensive background in USP regulations and applications allows for a broad perspective and a depth of training not commonly found in the industry. In addition to her microbiological work, Ms. Roberts is also a qualified trainer for document reviews of several analytical chemistry analyses commonly used in many FDA regulatory laboratories.

The detection of mycoplasmas in human and animal cell cultures is mandatory for every cell culture laboratory. These bacteria are common contaminants and can persist unrecognized in cell cultures for many years. This can affect research results as well as the purity of cell culture products. The reliability of the mycoplasma detection depends on the sensitivity and specificity of the method and should also be convenient to be included in the basic routine of cell culture quality assessment. Polymerase chain reaction (PCR) detection is one of the acknowledged methodologies to detect mycoplasmas in cell cultures and cell culture products. Although the PCR offers a fast and simple technique to detect mycoplasmas, the method is also susceptible to errors and can produce false positive as well as false-negative results. Thus, the establishment and the routine application of the PCR assay require optimization and the inclusion of the appropriate control reactions. This training will cover sample preparation, DNA extraction, PCR run, the analysis of the PCR products, and applicable regulations. Discussion will also include information on how to avoid artifacts produced by the method and other errors that may occur. Established properly, PCR is a reliable, fast, and sensitive method and should be applied regularly to monitor the contamination status of cell cultures.

• To identify which facilities, personnel that are impacted by FDA guidelines on cell culture use and production
• Become familiar with the different types of  cell cultures used and mycoplasma species
• Identify and become familiar with the PCR testing
• Implementing and maintaining a Quality environment (QA recommendations) and hazardous material considerations
• Familiarization with different testing protocols and how they impact product, raw material and in process
• What is required for compliance
• What are cell cultures and how are they used and tested
• New technologies and PCR products and research

• Types and examples of mycoplasma detection products
• Regulatory environment of cell culture production
• Personnel trainings and evaluation recommendations
• QA program and FDA regulations/recommendation impacts on PCR testing and cell cultures
• New technologies and areas of research opportunities

• Biotechnology manufacturing personnel and support staff in the biotechnology/pharmaceutical technology industries
• Quality Assurance personnel and support staff in the biotechnology/pharmaceutical technology industries
• Quality Control laboratory personnel and support staff in the biotechnology/pharmaceutical technology industries
• Finished product and medical device testing and manufacturing facilities
• Environmental Monitoring Program manager and support staff in the biotechnology/pharmaceutical technology industries
• Pharmaceutical and general contract laboratory companies/entities
• General laboratory personnel and staff who do routine work a controlled manufacturing environment

Regards,

Joshua                                                            

Training Manager

Email: [email protected]

Call us at : 1-732-7225220

Website: compliance.world