QuBAS Testimonials – Antibody Analytics

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Antibody Analytics is a leading immunology Contract Research Organisation (CRO) based in Motherwell, Scotland with a mission to facilitate breakthrough discoveries. They develop solutions for biopharmaceutical companies seeking to overcome substantial scientific challenges by providing data of outstanding quality.  Antibody Analytics was among the first adopters of QuBAS, so have been part of the journey of the software as it has evolved over the past seven years. We checked in with Fiona Miller and Dr. Louis Julien to find out how QuBAS is used at Antibody Analytics, and how it fits into their future plans.

Drawing on their immuno-oncology expertise, Antibody Analytics has built up an array of assay systems to recreate immune cell interactions in the tumour microenvironment, intended to be as faithful to the physiological processes they are emulating as possible. With a strong focus on novel and emerging therapeutic classes that are designed to modulate these processes, their assay platforms are applicable to oncology, auto-immunity, inflammatory disease and beyond.

Founded in 2015, the original focus of the company was providing antibody characterisation services. More recently, their work has expanded to support customers developing immunotherapies, including the addition of a cell line development group. A recent highlight of this team included a product launch in 2023 releasing IndEx-2, an in vitro cell-based platform that provides inducible expression of any target antigen of interest (TAOI).

“We have all the suitability criteria that can be applied for our controls, and when we do our fits – 4PL or linear – we have all the values we need, so upper asymptote, lower asymptote, EC50, slope: everything you can dream of. Plus, the goodness-of-fit, the parallelism, and, of course, the relative potency values. “
Dr Louis JulienAntibody Analytics

“It was really easy to get used to,” Julien emphasised when asked about his first experiences with QuBAS, “I was pleased with the software”. For both he and Miller, their arrival at Antibody Analytics was also their first encounter with QuBAS. “I had used other softwares at previous companies that I’ve worked with,” adds Miller, “and QuBAS was very much at use at Antibody Analytics when I started. So I got a very quick introduction!”

That’s perhaps no surprise: Antibody Analytics were one of the first QuBAS users, and provided key insights which helped shape how QuBAS is set up to aid users in developing their bioassay analysis. Today, the software is embedded in Antibody Analytics’ workflow where, as Miller describes, it proves a helpful tool for their potency assay work: “We use the software for our relative potency assays, mainly. Sometimes in other assays, but mainly in those circumstances. And what we like about QuBAS is that, in one place, it gives us the ability to not only generate that relative potency data but also to determine that the assay itself is valid. So we can have all kinds of checks on the data that we’re producing to make sure that it’s of sufficient quality.”

Julien agreed: “It’s an all-in-one package, which is great for us. We’ve tried some other software in the past and we had to do multiple analyses. Here, we have everything in one report. We have all the suitability criteria that can be applied for our controls, and when we do our fits – 4PL or linear – we have all the values we need, so upper asymptote, lower asymptote, EC50, slope: everything you can dream of. Plus, the goodness-of-fit, the parallelism, and, of course, the relative potency values. So, it’s really nice, and it’s already in the format we need for reporting, so we can just copy and paste all the graphs and forward it to the customer.”

“It is a really big benefit to us…Just to know that we don’t need to become experts in it ourselves.”
Fiona MillerAntibody Analytics

Even while providing this depth of functionality, Miller and Julien were clear that QuBAS remained easy to learn and use. “For the routine mode, you can get away without any training, because the only thing you need to do is import the data. It can run the analysis, and then it generates the report automatically,” noted Julien, “For the Explore [Development] mode, you need a little bit more training, so we have a training SOP and we often take our operators through some case studies with more experienced study scientists.”

Miller pointed out that Quantics were able to lend a hand when that training was required: “We did have some of our team attend a training course with Quantics, and those team members were the ones who went on to write our training SOP, so it really just filtered through from that. So we just put the information you gave us into our format, and that is all we need.”

Quantics is in a unique position among statistical software providers for bioassay that, as a statistical consultancy, it can provide expert assistance to QuBAS users in setting up and optimising their assay analyses. “It is a really big benefit to us,” Miller noted, “Just to know that we don’t need to become experts in it ourselves so we can focus on what we need to do and consult Quantics whenever we need that extra support.” “Of course, we are experts in our assays but not always experts in statistics,” added Julien, “I know that Quantics is always here and respond very quickly, most of the time within a day.”

As well as flexibility in Development mode, QuBAS’ routine mode offers robust GxP and 21 CFR pt11 compliance, meaning, once signed off, analysis results are prepared to be regulator-ready as standard. While Antibody Analytics are not themselves regulated, many of their clients are. “We’ve been audited by our customers, and by independent consultants on behalf of our customers,” outlined Miller, “and, once explained, we’ve never had any push-back or query on how it works or if it’s fit for purpose.”

This includes QuBAS’ unique Continuous real-time Validation (CrtVTM) process, by which all steps of the analysis are validated in real time. This means QuBAS comes pre-validated and ready to use for regulatory purposes straight out of the box. “I think the only piece of feedback we’ve had, from one auditor,” continued Miller, “is for us to write in a risk assessment the need to not validate it the way you would traditionally validate a piece of software. But they were happy with the explanation of the reason why that’s not needed.”

“We’ve been audited by our customers, and by independent consultants on behalf of our customers and, once explained, we’ve never had any push-back or query on how it works or if it’s fit for purpose”
Fiona MillerAntibody Analytics

Data integrity and security are also top of the agenda for Antibody Analytics looking to the future. Miller was quick to highlight how QuBAS’ cloud-based package – QuBAS Cloud – could provide an advantage in moving towards those goals. QuBAS Cloud is installed and maintained on servers by Quantics, meaning the IT burden for users is minimal. Miller elaborated: “It’s certainly something which we’re looking at more and more: how often is your server backed up? All of these things. To be able to offload some of that would be a huge consideration for us because, again, it’s something that we ourselves are not experts in. So to be able to hand that off to someone who knows what they’re doing would be a really big draw for us.”

It is clear, therefore, that QuBAS is a crucial component in Antibody Analytics’ work in supporting their clients’ assay development. As both Miller and Julien emphasised, QuBAS allows them to do the job they do best while still achieving the highest quality of statistical analysis. Thanks to QuBAS’ unique ease-of-use, as well as the years of experience available via Quantics’ support, the Antibody Analytics team can focus on what they’re experts in safe in the knowledge that the rest is in good hands.