Immunoassays are an important tool in biotherapeutic development, specifically in bioprocess analytics. For example, when using vectors such as adeno-associated virus (AAV), which are widely used in gene therapy for in vivo gene delivery, immunoassays are used for vector titer and impurity analysis. However, limitations in current methods can create bottlenecks in workflows, and the development of high-quality assays for biotherapeutic development can be difficult and time-consuming.
Automated platforms such as the Gyrolab® Immunoassay systems from Gyros Protein Technologies can improve the efficiency of assay-based processes, and can support the development of custom assays if required.
At the Bioprocessing Summit in Boston, we spoke with Todd Glynn, Regional Sales Manager, Northeast, from Gyros Protein Technologies. He told us about the Gyrolab immunoassay kits and solutions for cell and gene therapy viral vector titer and impurity analysis, and how they benefit their customers.
Q: Could you tell us about the Gyrolab Immunoassay Platform and its unique capabilities?
TG: The Gyrolab platform uses a nanoliter flow-through technology that allows you to miniaturize and automate immunoassays using our CD-based labware. With this flow-through technology we utilize an affinity column and that some customers have compared to a combination between an HPLC and an ELISA. So, using the flow-through approach allows for great reproducibility, lower matrix effects, short assay run times, and improved workflow efficiencies.
Q: Can you tell us a little bit about the solutions available from Gyros Protein Technologies for cell and gene therapies, viral vector titers, and impurity analysis?
TG: In terms of our solutions that we offer for cell and gene therapy and impurities testing, we offer quite a few. The ones that I'd like to highlight from our viral vector titer kits are AAV and p24. Gyrolab AAV Titer Kits (Gyrolab AAVX and AAV9 Titer Kits) are catching a lot of traction because they analyze the most common AAV serotypes of 1 through 10. The p24 Kit is also catching some traction as we're seeing more customers analyze the p24-containing lentiviral vectors, reflecting increasing demand for lentiviral-based gene therapies, and they appreciate the high precision results and the 80-minute assay turnaround time.
For impurities testing, I want to highlight our HEK 293 HCP Solution for Gyrolab for the detection of host cell protein (HCP) impurities. This is developed in collaboration with Cygnus Technologies, so the reagents are from their industry-standard ELISA kit. We do also offer Gyrolab CHO HCP and endonuclease impurity kits, as well as E. coli HCP kits.
I also want to share our cytokine-based assays for early drug discovery. Due to Gyrolab platform being an open platform, scientists can readily transfer assays and develop their own assays with ease – if there's something that you do not see on our menu, but you're interested in, we can have that talk with our custom assay development services group about developing something that fits your budget, and what you're looking for as well.
Q: What do your users like best while using kits and solutions either for viral vector titer, or impurity analysis?
TG: Our customers like that the Gyrolab platform is so robust and precise, and the reproducibility that you get through our kits. We heavily quality control our kits in our location in Sweden. So, there's high performance reliability between lots.
You put in your reagents, you set up the run using our really easy-to-use software, and you're able to walk away for an hour while the instrument does everything for you.
Gyros Protein Technologies
I think that's something that the scientists really like, as well as the ability to ‘set it and forget it’: The instrument itself is both a liquid handler and an analyzer. You put in your reagents, set up the run using our really easy-to-use software, and you're able to walk away for an hour while the instrument does everything for you.
Q: Finally, can you tell us how using Gyrolab immunoassays and other solutions positively impact on workflow and data quality?
TG: Data and workflow enhancements using our technology are mainly seen through the saving of time, and how robust our platform is. The data that you're receiving is going to be precise, and it's going to be reproducible. All of these things lead to a big cost and time saving for our customers. And then also to have the ability for your scientists and technicians to walk away and multitask. It just saves a lot of time. It's a really nice platform for miniaturizing and automating immunoassays to save analysis time.