“Gyrolab system is the platform of choice for pre-clinical studies and has a promising future throughout the biopharma development pipeline”
Staff at LGC Group (former Quotient Bio Analytical Sciences) became convinced in 2004–2005 that Gyros technology could fulfill two critical requirements in their work – small sample volumes and high throughput. Clare Kingsley, Associate Director in LGC Group, explains: “Being able to run immunoassays at a nanoliter scale is a real asset especially in pre-clinical studies, where sample volumes are limited, making Gyrolab system the platform of choice. The other deciding factor was the high throughput of the system, which has greatly increased our productivity.”
One project offered a real challenge – providing bioanalytical support for a 26-week toxicology study on a novel monoclonal antibody after the in-life phase had started. The Gyrolab system was used to develop a method with a broad dynamic range in just four days, completed validation in less than two weeks, and delivered all the QC’d data for more than 5000 samples on time. LGC Group became the first CRO to establish a GLP-validated method on the Gyrolab platform.
Backed by high performance technology, LGC Group takes pride in being able to offer their customers high levels of technical expertise, commitment and responsiveness. Clare adds, “A key part of being able to deliver is our supplier relationship. One of the major factors in choosing Gyros technology was the fact that we enjoy working with the company, and we have developed a strong partnership with Gyros over the years”.
Clare sees a promising future for Gyros technology through much of the biopharma development pipeline. “The Gyrolab platform already plays a significant role in early discovery and development of biological drugs. The platform’s ability to run generic assays would be very valuable when a drug candidate is being selected from a panel of monoclonal antibodies. Moving to phase II/III studies, the high throughput of the system would be a key advantage in handling the large number of samples. The system plays a major role in the generics and biosimilars markets, where the bioequivalence clinical trial designs involve large sample numbers and short reporting timelines. Being able to offer the high-capacity of the Gyrolab platform makes the client more confident that we, as a CRO, can handle the project.”
LGC Group present themselves:
Through its acquisition of Quotient Bio Analytical Sciences in December 2012, LGC has one of the world’s leading bioanalytical laboratories with extensive capabilities to support the development of new drug products, including small molecule generics and biosimilars:
• Bioanalytical method development
• Validation to the latest industry guidance
• Analysis of samples in support of all phases of development
• Expertise in the bioanalysis of small and large molecule drugs and biomarkers
• Microbiology services for the development of anti-infectives
• Molecular and cell-based assays
Quotient Bio Analytical Sciences arose from the world’s leading sports drug surveillance laboratory and builds on more than 45 years’ experience in high-integrity analytical science.
Our laboratories are GLP and GCP accredited and we are proud of our success in regulatory inspections.
With one of Europe’s largest bioanalytical facilities, we have a team of more than 160 scientists with expertise spanning LC-MS/MS, immunochemistry, molecular biology and microbiology. This large and flexible capacity allows us to allocate resources to match your needs, from small method development projects to large, complex multicenter clinical trials. We have a particular specialty in new method development and managing complex bioanalytical projects and Quotient Bio Analytical Sciences is a pioneer in the application of new science and technologies.
Our scientists regularly present scientific publications at key industry events and are also represented on committees such as the European Bioanalysis Forum (EBF) and the Global Bioanalysis Consortium (GBC); contributing to the setting of international standards in bioanalysis and biomarkers.
Our broad and tailored services are to the highest quality industry-lead standards and follow the same rigorous principles for all experimental work, so whether you require non-regulated discovery bioanalysis or full regulatory studies, you know that your samples are in safe hands.
You can find out more at www.lgcgroup.com