Same-day mycoplasma testing introduced to UK

Technical solutions provider, Reading Scientific Services (RSSL) has introduced the UK’s first same-day mycoplasma testing service for manufacturers of biologic medicines.

Testing times to confirm biologics are free from mycoplasma traditionally takes 28 days. Whilst faster PCR-based methods are accepted by the European Pharmacopeia, manufacturers still often have to wait two days or more to receive results.

RSSL is able to offer same-day testing services by using automated technology to extract DNA for testing. The company then performs mycoplasma tests using commercial analysis kits.

It’s hoped that the quicker service will assist the UK’s advanced therapy medicinal products (ATMPs) sector. Producing ATMPs requires taking a sample from a patient, processing it and re-administering it back into the same patient within 15 days, making speed a priority.

“Speed of service is critical to manufacturers of autologous cell and gene therapies. These companies have a window of 10 to 15 days to execute the entire supply chain and manufacturing process. They simply don’t have time to wait for traditional mycoplasma testing methods,” Phil Kuhlman, bimolecular analysis laboratory manager at RSSL, said.