Insights into Mycoplasma Testing
American Pharmaceutical Review interview with Jill Mariano, M.D.
Vice President of Bionique® Testing Laboratories
1) Could you provide a brief overview of your testing services and products for detecting mycoplasma in cell cultures?
Bionique® Testing Laboratories is an independent contract testing laboratory that is exclusively dedicated to mycoplasma testing. We have been providing mycoplasma testing services and consultation for biopharmaceutical companies, media/sera manufacturers, and research institutions for over 20 years. Our service offerings support mycoplasma testing of products ranging from early phase research cell lines, intermediate products, raw materials, and ultimately testing of finished biological products in compliance with FDA regulations. Furthermore, we provide qualification (mycoplasmastasis) studies, mycoplasma elimination services, and validation studies to meet our client’s needs. To support the growing trend toward rapid microbiological methods designed for mycoplasma testing, we are pleased to announce the availability of Mycoplasma Reference Standards with pre-defined GC/CFU ratios for the development and validation of PCR based methods.
2) What are features of the CELLshipper® Mycoplasma Detection Kit specifically?
The CELLshipper® Kit was specifically developed many years ago for the detection of mycoplasma contamination in cell cultures. The kit is comprised of a direct DNA fluorochrome staining assay. A 1 mL cell culture sample is fixed on a specially coated slide following a simple sample preparation procedure. The slide is then sent to Bionique® for final processing and interpretation with results typically available within 48 hours of receipt. DNA fluorochrome staining is a well known sensitive technique for mycoplasma screening. Although it is a relatively simple method technically, interpretation is highly dependent upon experience and expertise to distinguish accurately the fluorescent staining between mycoplasma, host cell nuclear fragmentation, bacterial contaminants or other test artifacts. The real advantages of this assay include ease of use, relatively rapid turn-around time, and affordability with four individual tests available per kit. It serves as an excellent screening tool for continuous cell lines and is appropriate for either adherent or suspension cell cultures.
3) As a global leader in mycoplasmal testing, how does Bionique® stay fully abreast of emerging technologies and methods to meet client needs?
This is an important question to ask. We attend numerous industry, academic, and regulatory sponsored conferences and events. In addition, we are actively involved with the Parenteral Drug Association (PDA), are a member of the PDA Mycoplasma Task Force, and participate in collaborative studies to further develop mycoplasma detection resources. These activities, along with extensive interaction between our scientists and our diverse client base, afford us the opportunity to gather and analyze information concerning emerging technologies and methods, regulatory insights, and evolving markets. Certainly, the on-going challenge for any organization is to recognize and respond to the changes that surround us.
4) Can you describe ways in which Bionique® confronts ever-changing regulatory requirements?
Our active participation at conferences as mentioned and close communication with regulatory authorities are critical in fostering awareness of emerging initiatives and regulations. As a cGMP compliant organization, we have to be proactive and remain current in this area. Besides ongoing education and training, we are subject to on-site client audits and regulatory authority inspections to ensure compliance and implementation of best practices within our facility.
5) What are the most notable challenges with mycoplasmal testing and how is Bionique® working to overcome these challenges?
It is a very exciting and dynamic time in the field of mycoplasma testing. Certainly the development and commercialization of innovative cell-based therapeutics as well the emergence and validation of rapid microbial methods, specifically PCR, have been recent focuses for us. Recognizing the advantage of alternative testing to allow for quicker turn-around time of results, particularly in the areas of cell-based therapeutics, resonated with our interest to explore new technologies and strategies for mycoplasma detection. However, determining the performance characteristics and the limitations of any assay are integral for optimization and the process of validation. For PCR, matrix components and the potential inhibition they may pose need to be taken into consideration. We are committed to ongoing internal R&D efforts and support of collaborative initiatives to evaluate new methods and technologies for mycoplasma detection. This level of scientific merit supported by robust quality systems enables us to continue to deliver services and advise to meet our client’s scientific and regulatory requirements for mycoplasma testing.
This article was printed in the September / October 2012 issue of American Pharmaceutical Review, Volume 15, Issue 6.
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