Byondis

Byondis is a clinical-stage biopharmaceutical research and development company based in Nijmegen, The Netherlands. Their 300 employees are focused on developing novel biological entities, including antibody-drug conjugates and monoclonal antibodies, to target specific intractable cancers and autoimmune diseases.

As one of the earliest adopters of QuBAS, Byondis has used the software throughout the bioassay lifecycle, from the early stages of development to pivotal clinical trials. They are currently deploying QuBAS in support of a commercial product. Quantics co-founder Ian Yellowlees caught up with Byondis Associate Director Zeban Kolen and Bioassay Development Specialist Sanne Gijsbers to hear about how QuBAS’ unique suite of features has supported their bioassay development pathway.

“I looked it up and we first met in 2017, so already 7 years,” Kolen said when asked about how he first came across QuBAS. “The contact we initially had was at the BEBPA [conference] and you showed me QuBAS, and you showed me the Continuous real-time Validation (CrtV^TM). I knew about you because I contacted you earlier on about a paper you had published, and also for your experience as a consultant for bioassays amongst other things. That was one of the reasons why we felt comfortable choosing QuBAS.”

At the time, QuBAS was just one of several software options on the table for Byondis. For Kolen, it was QuBAS ability to support bioassay development throughout the lifecycle which proved a decisive factor in choosing the software: “We wanted continuity: we knew that we would need multi-disciplinary involvement, so using one, fit for purpose software that met all our requirements throughout the bioassay lifecycle would facilitate that. In terms of functionality, we have the Development and Routine environments within the same software, which allows all stakeholders to become familiar with relevant aspects of the software.”

As beta testers, Byondis were among the very first to deploy QuBAS in the field. Quantics’ responsiveness to the input of those early users was, for Kolen, another key draw at the start of Byondis’ QuBAS journey: “Another thing which finally made us decide for QuBAS was the conversations we were having and your willingness to consider expanding functionality. In this case, to accommodate our need for impurity ELISA data to be analysed.”

Initially, potency assays were the main focus for Byondis, but this soon shifted to include ELISA assays. QuBAS’ interpolation functionality was developed alongside Byondis, including the unique and powerful Bursa-Yellowlees method. Once the accuracy and precision benefits of the novel method was demonstrated, it was fast accepted as the standard at Byondis. “I think the strength of the evidence and the advantages that come with it do convince people,” said Kolen.  “This is what we now use as a standard and it works very elegantly. We’re very happy with it.”

For Gijsbers, QuBAS’ main benefit comes in how it simplifies processes for the team at Byondis. “A big plus for us is that we can use QuBAS as a paperless system: we don’t have to worry about data integrity or audit system regulatory requirements,” she said, “things like a clear audit trail, electronic signatures, user levels, it’s all in QuBAS.”

She also emphasised the time-savings provided by QuBAS’ automatic data transfer functionality: “the automated raw data import from our plate readers, the automated analysis including system and sample suitability criteria evaluation, and automated pdf reports: it’s all possible. We can do a full analysis run in about 15 minutes.”

QuBAS is the only bioassay software package to offer robust real-time QA/QC of analysis and results in real-time using its Continuous real-time Validation (CrtV^TM) technology. I think this helps us within our organisation,” Gijsbers outlines, “we really reduced the IQ, OQ, PQ timelines significantly as the software is already released in a continuously validated state.”

Deploying updates to QuBAS also couldn’t be easier thanks to automatic validation provided by CrtV. “The implementation of future QuBAS updates is also scaled as low risk for us,” continued Gijsbers, “the existing data can be easily checked using the built-in validation.”

Byondis is among the many QuBAS customers who utilise bespoke plugins built to spec by the team at Quantics. These range in functionality from pre-processing data for import to mathematical operations such as wavelength subtraction, but Gijsbers was keen to highlight the importance of a plugin which allows them to more easily choose the metadata important for them. “We can also select which metadata we want to include,” she explained, “including the sample ID up to other critical method parameters such as reagent lot numbers, plate run dates, operators, etc. So we are really content with the flexibility in those plugins.”

That metadata is fed into QuBAS’ automatic trending functionality in the Monitoring room. “We collect 15-20 metadata parameters depending on the method,” Gijsbers outlines. “It’s really useful. If we add it in the lab, we don’t have to add anymore. In the case of method issues we can do easy troubleshooting, and we can trend our data on all these parameters that we added.”

The ease-of-use QuBAS offers also means that, for Byondis, onboarding of new users is extremely simple. “The routine training is quite short – I think it’s about 1 hour to demonstrate the whole data flow and let the user perform an automated analysis and data review themselves,” described Gijsbers. “For the Developer user we give a little bit more training to get experience of building and submitting a method. So this is all done in about two hours including a demonstration.”

Gijsbers continues by noting that, even if there are any issues while using the software, they are confident in the support provided by the team at Quantics. “We are really happy for all the quick responses,” she explained. “It has been within 24 hours, mainly faster, especially when we ran into a system issue or anything. The responses were really quick.”

As some of the first users of QuBAS, the team at Byondis have deployed QuBAS throughout their bioassay development cycle. QuBAS’ suite of unique and powerful features simplify and shorten processes at all stages, emphasising the industry-leading ease-of-use for which QuBAS is built. Whether it’s rapid automation features, robust validation in real-time, or expert support provided by the expert team at Quantics, QuBAS continues to prove a lynchpin of Byondis’ workflow.