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 Kingdomís 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 UKís 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.

ďSpeed 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 donít have time to wait for traditional mycoplasma testing methods,Ē 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 UKís 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

Applikon Biotechnology collaborates with Emerson for new Life Sciences R&D solution: V-Control

Applikon Biotechnology has launched V-Control for R&D scale bioreactors, a sophisticated automation solution developed in collaboration with Emerson. It uses a scaled version of Emersonís DeltaV distributed control system (DCS), DeltaV Discovery, designed for research and discovery laboratories. V-Control enables easy process control and data up-scaling in one platform. Furthermore, it provides organizations that already use the DeltaV DCS at production scale with reliable automation scaled to fit the needs of the laboratory environment, making tech transfer easier.
More info >>


White Papers

Data Technology as a Catalyst for Growth in the Life Sciences

AIGENPULSE

The life sciences industry is changing at a rapid pace. The need to develop the next blockbuster is pushing current technologies and methodologies to the limit. Scientific advancement over the last decades was embossed with giant leaps in knowledge, however, the new reality is that smaller incremental gains need to be carved out with ever increasing investments. In order to survive, progress and prosper in this new reality, a holistic approach to getting the most of research data is crucial. In fact, it will likely be the difference of being in existence in 5-10 years or not. For those bold enough to step into an area they are unfamiliar with, huge rewards are waiting.
More info >>


Industry Events

CPhI & P-MEC India

26-28 November 2019, India Expo Centre, Greater Noida, Delhi NCR, India

As the pharma industry looks increasingly towards India for high quality, low cost pharma solutions, CPhI & P-MEC India is the ideal event for companies wanting to pick up on the latest trends and innovations the market has to offer. At CPhI & P-MEC India, you will meet the movers and shakers from India's pharma machinery, technology and ingredients industries, giving you a competitive advantage that will help grow your business.
More info >>


©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement