DDS’ sponsors see the benefits of using Gyrolab system for their assays, which has become well established in the industry, and DDS now has three Gyrolab 5-CD instruments that gives the flexibility to run method development and sample analysis in parallel. Although the main application remains pharmacokinetic (PK) studies, analysing a range of matrices including plasma, serum and synovial fluid, the bioanalytical team at DDS have utilized the ADA mixing CD application and are also investigating the use of Gyrolab affinity module, which is of increasing interest for their sponsors.
DDS’ main focus is on supporting clinical studies but have seen the advantages of using Gyrolab in pre-clinical studies. 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. 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. More recently, two ongoing projects have encountered technical hurdles when run on other immunoassay platforms and moving to Gyrolab system has resulted in more promising results. The Gyrolab system runs immunoassays in a different way compared to the standard sandwich assay.
“Replacing periods of passive binding with short incubations and nanofluidics changes the paradigm of how the assays are working. Assays that don't work in a standard format can work in Gyrolab system, which has helped in several cases where ELISA has failed. Transferring to Gyrolab system can lead to a step change in performance.”
Rachel commented “The system’s flexibility is an advantage when developing immunogenicity assays. The automated nature of the system enables us to develop complex assays involving multiple reagents mixing steps within far shorter timeframes. Added to that, the chemistry of the column-capture format can offer improved drug- and target-tolerance in assays that are hitting technical roadblocks on other platforms.”
Backed by high performance technology, DDS 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. The staff at Gyros Protein Technologies are great at reacting to client needs, both for instrument support and technical aspects of assay development. Having access to a third party that can look at things from a different angle is very valuable.”
Rachel sees the benefits for utilizing Gyrolab 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. The high throughput of Gyrolab system together with our experience, gives our customers confidence that DDS can support the analytical demands of phase II and phase III studies.”
Looking into the future, the bioanalytical team at DDS see Gyrolab system as their principle PK development tool and increasing a platform for ADA assays and will continue to use their expertise in Gyrolab technology to improve support to their sponsors.
About DDS
As one of Europe’s largest dedicated bioanalytical centres and a recognised Protein LC-MS and Immunogenicity Centre of Excellence, we are industry leaders in providing integrated bioanalytical support across all phases of drug development and recognised for our leadership in science and technology.
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 specialty in new method development and managing complex bioanalytical projects.
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
- Services include PK, PD and immunogenicity which can be supported by in-house data management, statistical analysis and kits and logistics teams.
- Cell-based assays and flow cytometry
Find out more at https://www.drugdevelopmentsolutions.com
