spacer
home > white papers > RSSL introduces same-day mycoplasma testing service in UK - RSSL
WHITE PAPERS
logo_RSSL.jpg

RSSL

phone +44 (0)118 918 4024
web http://www.rssl.com
email University of Reading, Whiteknights Rd, Reading, West Berkshire RG6 6LA

RSSL introduces same-day mycoplasma testing service in UK

Reading Scientific Services Ltd (RSSL), a leading provider of scientific and technical solutions to the global biopharmaceutical, 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.

The highly trained and professional team at RSSL use automated technology to extract DNA for testing. RSSL then performs mycoplasma tests using the leading and regulator-accepted commercial analysis kits.

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.

“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 2018.2

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



References
1. 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)
2. 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)
spacer

Member login

E-mail address:

Password:
Remember me


News and Press Releases

AirBridgeCargo expands its passive pharma solutions in partnership with SkyCell as it achieves the two-fold volume increase

AirBridgeCargo expands its passive pharma solutions in partnership with SkyCell as it achieves the two-fold volume increase AirBridgeCargo Airlines (ABC), one of the leaders in transportation of pharmaceutical products by air, and Zurich-based cold-chain ULD manufacturer SkyCell have sealed their partnership for the lease of all types of SkyCell containers to meet the demand for evolving volumes of passive pharmaceutical shipments, which reached around 3,500 tonnes for 1Q 2019 YOY and demonstrated a two-fold increase.
More info >>


White Papers

Customising the Cold Chain

World Courier

Of all the statistics emerging around the global pharmaceutical industry this year, two big numbers capture the attention of both manufacturers and their logistics partners: $248 billion, the amount the “BRIC” nations (Brazil, Russia, India and China) are poised to account for in pharmaceutical sales for by 2016; and $8 billion, the amount global pharma will spend on cold chain logistics in 2014. Why are these two numbers so noteworthy? They demonstrate that as R&D goes, so goes logistics. As products evolve to meet demands for more targeted therapies, demand for more targeted logistics solutions grows as well. And that means a need for customization for everything from clinical trial samples to finished product.
More info >>


Industry Events

PPMA Total Show

1-3 October 2019, Birmingham

About PPMA Total Show PPMA Total is one of UK’s largest processing and packaging machinery exhibitions. Building on the success of the PPMA Show in 2018, PPMA Total returns to the NEC, Birmingham, on 1-3 October 2019 for another show-stopping event.
More info >>


©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement