Mycoplasma contamination presents a serious concern for biopharmaceutical companies that manufacture cell-derived therapies, as these bacterial strains are a common cause of cell line contamination. This can compromise the safety and quality of cell culture-derived products, increasing the likelihood of expensive product recalls and loss of productivity. Therefore, it is vital that biopharmaceutical companies routinely test for mycoplasma contamination and identify any potential contamination points throughout the manufacturing process.
Save time on Growth Promotion
Mycoplasma testing is a lengthy process with 14-28 day incubation periods. To save time and simplify the growth promotion process, enumerated mycoplasma reference strains can be used. These strains are also ideal for validating test methods, qualifying culture media and can be used as external controls in evaluating method sensitivity and specificity.
Microbiologics Enumerated Mycoplasma kits simplify compliance with USP <63> / Ph. Eur. 2.6.7 by eliminating the need for manual enumeration. Ready for immediate inoculation or serial dilution, Enumerated Mycoplasma can quickly confirm the ability of your media to support the growth and detection of Mycoplasma.
Benefits of Enumerated Mycoplasma Kits
- Delivers 10,000 – 99,000 CFU/ml (E4)
- Can be used with agar or broth media
- Ready-to-use format saves time and money
- Eliminates the 48 hours to 4 weeks of wait time prior to plating
- Strains are ≤15 passages from reference culture
- Traceability to reference cultures ensures authenticity
Mycoplasma QC Strains Available:
- 01155ME4 Mycoplasma gallisepticum derived from NCTC 10115
- 01156ME4 Acholeplasma laidlawi derived from NCTC 10116
- 01158ME4 Mycoplasma orale derived from NCTC 10112
- 01177ME4 Mycoplasma pneumoniae derived from NCTC 10119
- 01178ME4 Mycoplasma hyorinis derived from NCTC 10130
- 01176ME4 Mycoplasma fermentans derived from NCTC 10117
Click here for illustrated instructions on using Enumerated Mycoplasma.
If you would like more information on the Enumerated Mycoplasma kits or any Microbiologics quality control strains, contact MSC below: