“Gyrolab system is the platform of choice for pre-clinical studies and has a promising future throughout the biopharma development pipeline”

 

LGC.pngStaff at LGC Group became convinced in 2004–2005 that Gyrolab technology could fulfil two critical requirements in their work – small sample volumes and high throughput. Rachel Green, Operations Director at 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 significantly 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. Rachel adds, “A key part of being able to deliver is our supplier relationship. One of the major factors in choosing Gyrolab technology was the fact that we enjoy working with Gyros Protein Technologies, and we have developed a strong partnership with them over the years”.

Rachel sees the advantages for utilising 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 is invaluable when a drug candidate is being selected from a panel of monoclonal antibodies. The system plays a major role in the biosimilars market, where the clinical trial designs involve large sample numbers and short reporting timelines. High throughput of the Gyros platform together with our experience, gives our customers confidence that LGC can support the analytical demands of phase II and phase III studies.

An additional advantage is the system’s flexibility to develop immunogenicity assays. The automated nature of the system enables us to develop complex assays involving multiple reagent mixing steps within far shorter timeframes. Additionally, the chemistry of the column-capture format can offer improved drug - and target - tolerance in assays which are hitting technical road-blocks on other platforms.”

About LGC
With one of Europe’s largest bioanalytical facilities, we have a team of more than 150 scientists with expertise spanning LC-MS/MS, immunochemistry and molecular biology. This large and flexible capacity allows us to allocate resources to match our customer’s needs, from method development projects to large, complex multi-centre clinical trials. We have particular speciality in new method development and managing complex bioanalytical projects, and we are pioneers in the application of new science and technologies.

Our laboratories are compliant with regulatory requirements for GLP and GCP (and local legislation) and we are proud of our success in regulatory inspections.

Summary of capabilities:

  • Bioanalytical method development 
  • Validation to the latest industry guidance
  • Analysis of samples in support of all phases of drug development
  • Expertise in the bioanalysis of small and large molecule drugs and biomarkers
  • Molecular and cell-based assays

You can find out more at LGCgroup.com/DDS