While biopharmaceutical production offers considerable advantages over traditional drug manufacturing methods, use of live bacterial cultures in place of inert, controllable chemical reactions increases the risk of contamination.
A major problem associated with culture derived drugs is the risk of contamination by Mycoplasma, tiny intracellular organisms which thrive in bioreactors and are both immunogenic and potentially infectious.
Traditional Mycoplasma detection methods for medicinal products, which are required by pharmacopoeias and drug regulators worldwide, use growth on culture media to identify contamination organisms.
These methods, while effective, are hamstrung by the time they take to produce definitive results. Such delays impact on when key decisions in the manufacturing process can be made and can have a significant affect on efficiency and costs.
In contrast, nucleic acid detection methods, such as MicroSEQ, use a quantitative polymerase chain reaction (PCR) approach based on the direct analysis of genetic material.
Such methods are reliant on neither Mycoplasma viability nor growth for identification purposes and can produce accurate results in hours rather then days.
The MicroSEQ system, which is part of Applied Biosystem’s SEQ range, is capable of identifying up to 90 species of Mycoplasma in one assay run, a feat that would require a wide range of specific growth media using traditional culture-based detection.
Robert Barnett, vice president of Applied Biosystems’ applied markets division, commented that: “Comprehensive monitoring of pharmaceutical and biopharmaceutical manufacturing facilities is critical for ensuring product safety and quality.”
He added that the rapid and accurate results offered by the MicroSEQ system will ultimately help drugmakers to reduce the risk of bringing new drug products to market.
Rapid detection methods
The increasing cost pressure has seen manufacturers seek to improve efficiency in all aspects of production in an effort to maintain a competitive edge. This extends to quality control measures such as contaminant detection methods.
Robert Johnson, who chairs the European Compliance Academy’s working group on rapid microbiological methods, said that: “results from rapid molecular-based testing [methods] are providing better information for more timely and informed decision making and [are] increasing the safety and quality of pharmaceutical products.”
Dr Johnson went on to say that regulators and pharmacopoeias are catching on to the benefits of the molecular methods that are emerging as the new gold standard for contaminant and impurity analysis.
“Faster and more accurate detection of Mycoplasma can have a significant impact on preserving the high quality of the biopharmaceutical manufacturing process,” he concluded.