Sunday, 31 March 2019

RSSL Introduces UK's First Same Day Mycoplasma Testing Service for Biologics


Reading Scientific Services Ltd (RSSL), a leading provider of scientific and technical solutions to the global pharmaceutical and biopharmaceutical sectors, has introduced the United Kingdom’s first same-day mycoplasma testing service for manufacturers of biologic medicines.

Traditionally, the testing required to confirm biologics are free from mycoplasma, a genus of small, hard-to-detect bacteria that lack cell walls, took 28 days and used an agar and broth method. The European Pharmacopoeia now accepts a faster, PCR-based method but other limits on turnaround times mean manufacturers still typically need to wait two or more days to receive results.

RSSL has used its established processes for sample handling and tracking to eliminate the constraints that have kept turnaround times above 48 hours. If a manufacturer gets a sample to RSSL by 9:30am, it will receive mycoplasma testing results by 5pm.

RSSL has reduced the time it takes to execute this process to serve the UK’s fast-growing advanced therapy medicinal products (ATMPs) sector. Production of ATMPs such as autologous cell and gene therapies entails taking a sample from a patient, processing it and re-administering it back into the same patient within 15 days, making speed a priority.

The highly trained and professional team at RSSL initially use automated technology to extract DNA for testing, followed by real-time PCR for mycoplasma using regulator-accepted commercial analysis kits such as the Roche MycoTOOL Mycoplasma Real-Time PCR Kit. RSSL is offering clients a choice of Real-Time PCR based kits based on their individual requirements.

Multiple sample types can be used for the analysis although spent culture media is preferred, as this is easily available and will contain any mycoplasma that may have contaminated the process. Some preliminary sample validation is still required to ensure there are no components within the test material that will interfere with the PCR technique.

“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, Biomolecular Analysis Laboratory Manager at RSSL, said.

RSSL offers longer turnaround times that may be more suitable for producers of traditional biologics but, with the UK emerging as a leader in ATMPs, it saw an unmet need for a one-day service. With 64 developers of ATMPs, the UK has more companies in the sector than any other European country.1 The manufacturing capacity in place to serve these companies increased by 60% in the year preceding November 20182.

RSSL, which collaborates closely with commercial kit suppliers, offers the mycoplasma testing service as part of a broader suite of ATMP support. ATMP companies rely on RSSL for tests of raw materials, process and product related impurities , host cell protein and DNA and pharmaceutical microbiology . RSSL also provides GMP training , product issue troubleshooting and contaminant identification .

Whatever your testing requirements, contact the RSSL customer services team to discuss your requirements further on +44 (0)118 918 4076 or email enquiries@rssl.com.

Posted by Pharmaceutical Microbiology

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