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


Reading Scientific Services Ltd (RSSL) has introduced the United Kingdom’s first same-day mycoplasma testing service for manufacturers of biologic medicines. Traditionally, using an agar and broth method the testing required 28 days. However, now the European Pharmacopoeia accepts a faster, PCR-based method although 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. The lab has evaluated two commercial analysis kits, MycoSEQ™ Mycoplasma Detection Kit from Life Technologies and the Roche MycoTOOL Mycoplasma Real-Time PCR Kit. Both of these kits have their advantages and therefore RSSL are offering clients a choice 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.

 

References

  • Annual Review 2018 highlights work of the CGT Catapult. Available at: https://ct.catapult.org.uk/news-media/general-news/annual-review-2018. (Accessed: 3rd January 2019) 
  • Research Shows UK’s Growing Cell and Gene Manufacturing Industry. Available at: https://ct.catapult.org.uk/news-media/manufacturing-news/research-highlights-uk-growing-manufacturing-industry. (Accessed: 3rd January 2019)

    

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Date Published: 21st January 2019

Source article link: Reading Scientific Services Ltd (RSSL)


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