Understanding which compendial and non-compendial methods to use for Mycoplasma detection is a must for companies in order to meet the requirements outlined by regulatory bodies (EU and FDA).
This webinar will discuss the various methods of detection and the strategy needed to ensure the cell line and cell line product meet the safety requirements of the product.
Learning Objectives:
Regulations
Understanding why Mycoplasma is important to product quality
Compendial Methods
Non-compendial methods
Advantages of each method
Disadvantages of each method
Where in the process you can use the methods discussed
Why Should You Attend:
Mycoplasma testing is a required testing method for determining the quality of your cell line and the cell line product. Throughout the production of the cell line, mycoplasma testing is required by the regulatory bodies (EU an FDA). Methods for determining Mycoplasma must meet the requirements of USP <63> and EP 2.6.7.
As outlined in this program are compendial methods for detecting Mycolplasma and non-compendial methods for detection. The objective of this webinar is to discuss the methods of detection and the advantages and disadvantages of each. As well as discuss the importance of having a Mycoplasma free cell production process.
Areas Covered
FDA regulations
EU regulations
USP <63>
Non-compendial based methods for Mycoplasma detection
Compendial methods for Mycoplasma detection
Instructor Profile
Carl Patterson, M.S. has completed twelve plus years in the biotechnology, pharmaceutical manufacturing and quality fields. He completed his Bachelor's of Science in Microbiology from the University of Texas.
Also, has completed specialized certificates in biotechnology manufacturing, quality control, and quality assurance from UCSD, and has completed his Master's of Science in Biomedical Quality Systems from SDSU.
Through the years, has worked with
several companies in regards to aseptic
processing and has helped to insure the
expectations, related to aseptic
processing, have been met.