Taking the difficulties out of assay development

Assays are an important tool in biotherapeutic development. Developing a high-quality ligand-binding assay for preclinical, clinical, or bioprocess applications can be difficult and time-consuming, especially if a company does not have the resources or expertise. In circumstances where resources are constrained but time and results are of the essence, it often makes sense to outsource the development of assays to experts.

Since the summer of 2021, Gyros Protein Technologies have offered Custom Assay Services_¹ to deliver just that. In this article, we speak to Maria Gianneli, Product Manager for Consumables and Ann-Charlott Steffen, Principal Scientist from Gyros Protein Technologies about the Custom Assay Services and the support they provide.

The need for a new Custom Assay Services offering became apparent when Gyros Protein Technologies spoke to many of their customers in pharma and biotech about the challenges that they face when using immunoassays in their research. As Gianneli explains, “besides everything else that we offer to our customers – including the [Gyrolab^® immunoassay] platforms, ready-to-use kits and solutions, and service and support – we decided to offer this kind of service after listening to our customers and their needs.”

Time, staff resource and experience are all required to develop a high-quality assay but one or all of these might not be available. “We saw that after COVID-19 especially, people have a lot of projects that are reinitiating [...] Companies want to put their resources into specific projects yet have a lack of resources. They want more data in less amount of time,” attests Gianneli. “With our highly experienced scientists, we can offer these services, so that they can do that. They can put the resources into other projects, and they can prioritize accordingly.”

Meeting customers’ needs

Speaking to customers about their pain points enabled Gyros Protein Technologies to develop a set of services that provides the support that is needed. Gianneli explains, “We decided that we needed to offer three types of custom assay services: labeling of biomolecules with either biotin or Alexa [Alexa Fluor^® 647, Thermo Fisher Scientific], custom assay development services, and custom kit development services. So, three different types of service, but with a lot of flexibility.”

The biomolecule labeling service enables efficient conjugation of antibody or protein reagents with fluorescent labels (for use as a detection reagent) or biotin (for use as a capture reagent), and improved consistency. Gianneli elaborates, “one advantage of our services is that we can offer batch labeling. We label a large amount of reagent that the customers can use for many years, if stored appropriately, with no batch variation.” There is also quality documentation provided, ensuring peace of mind for high quality and longevity.

Crucially, the service supports customers lacking the capacity or resources to produce their own assays, potentially delaying their biotherapeutic development project. Assays are developed internally by Gyros Protein Technologies and are delivered ready to implement in customers’ own laboratories. This can be helpful for a variety of reasons, as Steffen attests, “Sometimes customers don't have the skills in-house right now. There are also cases where our internal knowledge of the platform gives you a little bit of extra help to optimize the assays the right way – sometimes we can reach a little bit further.”

Gyros Protein Technologies can also provide flexibility and combine these different aspects to support whatever is needed for customers to move forward with their projects. “We can offer a combination of services, for instance, labeling with some kind of degree of assay development,” explains Gianneli. “And not only deliver labeled reagents, but also aliquot those reagents in concentrations and amounts that the customer can use directly on their site when we do the transfer.”

Support does not end with the delivery of the assays and reagents themselves – Gyros offers ready-to-use assay protocols described by Steffen as “‘plug-and-play’ solutions. They are protocols that the R&D team has developed internally, and they are based on commercially available reagents so that the customer can use them as starting points to do their own assay development. They are a very easy way to start the development.”

Gyros Protein Technologies also supports customers with staff training and continued help through their local Field Applications Scientist (FAS). This can range from beginners training to advanced users training, lunch and learns, and webinars – working with customers to find the best way to share their knowledge.

Trusting the experts

Gyros Protein Technologies are the experts when it comes to developing assays with the best performance possible. This means that they can support customers with not only the best assays for their needs, but with a fast turnaround time as well. “One assay development on the customer side might take a few weeks,” explains Gianneli, “but our R&D team, because of the expertise that they have been accumulating throughout the years, might be able to deliver in one week.”

“We have a lot of experience. We are continuously working with biomolecule labeling and assay development on the [Gyrolab^® immunoassay] platform, and we also have kits as well,” concludes Steffen. “So, we have a kit development process where we really look at how an assay performs on our system. We know how to optimize things, and we have excellent FAS support. Very technical people, highly skilled FAS scientists that help our customers [in the field]. It's our strong point, I would say.”

Several companies have already utilized the Custom Assay Services by Gyros Protein Technologies, saving them time and resources and keeping their projects on track. The service has the potential to help many more in the future, lending their expertise to ensure that partner companies achieve their aims.

References:

Gyros Protein Technologies. Gyrolab^® Custom Assay Services. Available from: https://www.gyrosproteintechnologies.com/gyrolab-custom-assay-services