Mycoplasma DNA Detection Kit

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Anyone involved in cell culture is familiar with mycoplasma. It is estimated that 5%–30% of cell lines worldwide are contaminated with mycoplasma [1]. Even for biological products produced under strict protocols, the contamination rate reached up to 15.8% according to testing data from the National Institutes for Food and Drug Control (NIFDC) between 2003 and 2016 [2]. For biopharmaceutical companies, developing new and rapid mycoplasma detection methods for in-process monitoring of raw materials and intermediates, as well as release testing of final products, has become urgent.

To meet the needs of biopharmaceutical, stem cell and related enterprises, Rocgene has launched its Mycoplasma DNA Detection Kit, enabling rapid mycoplasma detection within 4 hours. It helps companies test raw materials, cell banks, and bulk samples, reducing the risk of mycoplasma contamination.

What is Mycoplasma?

Mycoplasma are microorganisms ranging in size between bacteria and viruses, with a diameter of only approximately 0.15–0.3 μm. They lack a cell wall and are pleomorphic, allowing them to pass through 0.22 μm bacterial filters. They are named “mycoplasma” for their branched, filamentous fungus‑like structure [1]. On solid media, their typical colonies show an “fried egg” appearance [3]. Mycoplasma are closely related to Gram‑positive bacteria in evolution, so some scholars classify them as bacteria.

There are more than 200 known species of mycoplasma, with about 10 commonly encountered in cell culture. Depending on the operating environment and source of raw materials, frequent contaminants include human‑origin Mycoplasma orale, Mycoplasma hominis, and Mycoplasma fermentans; bovine‑origin Mycoplasma arginini and Acholeplasma laidlawii (usually from fetal bovine serum); and porcine‑origin Mycoplasma hyorhinis (typically from porcine trypsin) [4].

Mycoplasma Regulations

Mycoplasma contamination directly impairs cell growth, reduces cell density, and lowers the yield of target products. Meanwhile, pathogens such as Mycoplasma pneumoniae can cause human diseases. Therefore, regulatory authorities worldwide require testing of cell banks, bulk products, and other materials, with no mycoplasma detected.

Pharmacopeias of major countries generally include culture methods and DNA staining methods for mycoplasma detection. However, these methods have long turnaround times and may miss non‑cultivable species such as Mycoplasma hyorhinis. For example, according to NIFDC statistics, M. hyorhinis accounted for the highest proportion (44/70) of contaminated biological products [5]. For this reason, pharmacopeias including EP, USP, and JP have included nucleic acid amplification techniques (NAT), i.e., PCR, for mycoplasma detection, subject to method validation. The 2020 edition of the Chinese Pharmacopoeia still uses traditional culture and DNA staining methods, with the widely expected NAT method not yet officially included. Nevertheless, since cell therapy products contain living cells, culture methods are practically unsuitable for release testing. Thus, the CDE has issued guidance supporting companies in developing alternative methods for mycoplasma detection [6]. In practice, more than half of antibody developers and nearly all cell therapy companies have adopted qPCR for in-process or release testing of mycoplasma.

Rocgene Mycoplasma Detection Kit

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