Optimizing Immunoassay Method Development and Automation
In today's bioanalytical landscape, precision, efficiency, and robust processes are critical to the successful development of life-saving medicines. Resolian has evolved significantly in its approach to immunoassays, from the start of method development through automation of sample testing. In this video, Richard Hughes describes the culture shift within the company and the steps taken to improve service delivery, build career paths for scientists, and implement automation to meet customer needs. This transformation reflects Resolian's commitment to offering industry-leading bioanalytical services.
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Read on to read the summary on how Resolian is driving advancements in immunoassay bioanalysis.
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Aligning Expertise with Customer Needs
Over the past two decades, Resolian’s Immunoassay team has seen rapid growth, driven by an increase in large molecule bioanalysis and the expansion of service offerings. Initially, teams were structured around individual customers, creating challenges as services diversified. Each team handled pharmacokinetics (PK), biomarkers, and immunogenicity for its assigned clients, but this approach limited the depth of scientific expertise within the teams.
Recognizing the need for specialization, Resolian restructured its teams to focus on specific analytical techniques. This transition created distinct groups of subject matter experts in areas like immunogenicity, biomarkers, and PK assays. This structure has enabled us to build a much stronger scientific and technical foundation, positioning Resolian as a leader in these key areas.
By allowing scientists to focus on specific techniques, Resolian has improved not only the quality of its services but also the depth of scientific knowledge within the organization. This change has enhanced our ability to communicate with customers about their specific assays, offering expert insights into complex bioanalytical challenges as well as providing growth opportunities for analytical scientists.
Building a Technical Career Path
One of the challenges we faced before this reorganization was the limited career progression opportunities for technically inclined scientists. Previously, career advancement often led scientists away from the lab and into project management or regulatory roles. This shift did not align with the interests or skills of many scientists. We recognized the need for a career path that kept talented individuals engaged in the lab.
In response, we developed a technical specialist career path. This role allows scientists to stay in the lab, focusing on method development and technical leadership, while also engaging with customers to discuss scientific challenges and opportunities.
For customers, it means they get a technical point of contact, and for our scientists, it creates a clear path for professional growth. It also gives analytical scientists experience dealing with customers and a view into the broader process of drug development.
This technical specialist role has allowed Resolian to retain talented scientists while ensuring that methods are developed and maintained by those with a deep understanding of the science behind them.
Strengthening Method Development Through Rigor and Documentation
As Resolian grew, so did the backlog of assays awaiting development and validation. To address this bottleneck, the team implemented several strategies to add rigor to the method development process and ensure that assays were ready for validation before moving forward.
One of the key changes was standardizing how method development scientists document their work, particularly around decisions made in the development process. Resolian introduced a standardized method development spreadsheet, which includes raw data, processed data, graphs, and a clear record of the decision-making process. This documentation is not only valuable for internal purposes but also provides transparency for customers, who appreciate seeing consistent reporting across all projects.
In addition to improving documentation, Resolian introduced a peer review process for method development. Before an assay can progress to validation, a senior scientist reviews the method development workbook to ensure it meets all necessary criteria, including the decision-making process. This step acts as a quality checkpoint, preventing underdeveloped methods from moving forward.
Resolian also instituted a pre-validation phase, during which validation experiments are conducted in a non-regulated environment. This phase helps identify potential issues before formal validation, reducing the risk of delays during the validation process.
While customers sometimes want to move ahead quickly following method development, this process reduces the risk of having to go back and modify methods that fail in validation.
Critical Reagent Management
One of the most important aspects of immunoassay development is managing critical reagents—substances like antibodies, reference standards, and detection reagents that are essential to assay performance. Variability in critical reagents can lead to inconsistencies in assay results, which can delay projects and compromise data integrity.
To address this challenge, Resolian has standardized its approach to critical reagent generation and characterization. Critical reagents are generated in bulk during the pre-validation phase, ensuring that enough reagents are available to carry projects through validation and sample analysis. This proactive approach reduces the risk of running out of reagents mid-study, which could otherwise cause significant delays.
Deploying Automation Selectively?
As bioanalytical CROs face increasing demand for faster turnaround times and greater throughput, automation has become a critical tool for improving efficiency. However, automation must be applied thoughtfully. Automation brings the need for training and maintenance.?
?“You can’t just put robots in the lab and expect everything to run smoothly". Richard Hughes
We refer to our approach as “islands of automation”—targeted use of robotic systems for specific tasks within the broader process.
One of the key areas where Resolian has implemented automation is in primary sample aliquoting and dispensing. By using Hamilton robotics to automate this tedious and error-prone task, Resolian has freed up valuable analyst time while ensuring greater consistency and accuracy. These robotic systems can prepare sample plates that are ready for analysis at any time, which allows Resolian to maintain flexibility in its scheduling and reduce downtime.
While automation has improved efficiency in many areas, some tasks still require human expertise. For example, sample preparation for microfluidic systems like the GyroLab must be done with extreme care to avoid introducing bubbles or particulate matter that could disrupt the flow of reagents. In these cases, analysts work alongside robotic systems, each playing to their respective strengths.
Career Development in Automation?
As automation technology becomes more sophisticated, there is a need for dedicated expertise in this area. The company has created full-time equivalent (FTE) positions for automation specialists, who are responsible for developing and maintaining robotic systems, training analysts, and engaging with customers.
These specialists play a key role in fostering a culture of innovation within Resolian, driving enthusiasm for automation both internally and externally. Having someone who is passionate about the technology and can communicate its benefits to both colleagues and customers is critical to its success.
Risk-Based Assessment and Automation in Biomarker Analysis?
One of the areas where Resolian and our customers have seen the greatest benefit from automation is in exploratory biomarker analysis. These exploratory analyses are used by customers internally and do not always need the same level of scrutiny as assays intended for submission to regulatory agencies.
By applying a risk-based approach to auditing and compliance, Resolian has been able to streamline its processes for exploratory studies, using automation to deliver results more quickly without compromising quality. Technologies like Quanterix and ProteinSimple EllaTM have been particularly valuable in this area, allowing Resolian to run fast, automated analyses with minimal analyst intervention.
Conclusion?
Resolian’s approach to immunoassay method development and automation reflects a deep commitment to scientific rigor, customer satisfaction, and innovation. By restructuring its teams, creating technical career paths, and thoughtfully implementing automation, we have positioned ourself as a leader in the bioanalytical CRO industry. As the demand for bioanalytical services continues to grow, Resolian’s focus on quality, efficiency, and customer engagement will ensure its continued success in meeting the needs of its clients and the patients they serve.
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