The role of digital solutions and precision in achieving bioanalytical excellence
As biopharmaceutical and biotech companies navigate increasingly complex research and development (R&D) pipelines, one thing is clear: precision in bioanalysis remains a necessity. The requirements that come with regulatory compliance and the commitment to creating safe and effective medications enable an environment where the integrity, reproducibility and accuracy of bioanalytical data is vital for informed decision-making.
As drugs become more complex, with new therapeutic modalities they are more challenging to manufacture and demand new modes of testing to ensure they meet evolving industry standards.
Common challenges that biopharma labs face include increasing regulatory complexity, rising drug development costs, supply chain disruptions and adopting new technologies. Rising drug development costs can be attributed to the fact that around nine out of ten drug candidates fail to win approval – however studies of failures have shown that those candidates employing biomarkers and companion diagnostics show greater success rates.
Novel approaches to biomarker discovery and characterization at scale such as those employed by the SCALLOP consortium coupled with efficiency enhancing solutions such as laboratory information management systems (LIMS) designed specifically for regulated bioanalysis, can help biopharma companies characterize biomarkers to achieve higher success rates and reduced development costs.
Importance of precision in bioanalysis throughout the drug development process
By deploying digital solutions, such as LIMS, to address the challenges that come with ensuring precision in bioanalysis, labs can generate accurate, reproducible data throughout the drug development process. In fact, recent research details how digital solutions coupled with lab automation can aid precision by decreasing opportunities for human error.
When testing the impact of digital solutions in bioanalysis, scientists looked at the difference between duplicate versus single screen results of a preclinical immunogenicity assessment and found that both approaches produced reliable and accurate data.
One area that demonstrates the importance of precision in bioanalysis is in vaccine development. With LIMS, biopharma companies can verify clinical outcomes by conducting digital studies that garner reproducible results.
In recent years, pharmaceutical labs have utilized LIMS to accelerate phase 1 clinical testing of vaccine candidates, and the technology helped to vastly reduce failure rates. By synchronizing efforts that would increase R&D productivity and accelerate clinical trials to reduce bottlenecks, the companies can bring vaccines to market faster.
These studies showcase how new technologies that better connect the lab, reduce human error and enhance analysis while enabling precision in bioanalysis and helping biopharma companies bring new drugs from molecule to market.
Addressing common challenges with laboratory digitization
Labs also need digital solutions to help them comply with the evolving regulatory landscape. When the solutions are built to specifically keep up with the changing regulatory landscape, the intellectual burden of implementing and validating new regulations is significantly reduced to the execution of lab specific performance qualification (PQ) tests for the new functionality. Installation Qualification (IQ) and Operational Qualification (OQ) can be carried out with vendor provided automated testing agents or manual testing scripts. Working with LIMS systems that are built to ensure regulatory compliance allows scientists to focus on bringing new drugs to market rather than burdensome and protracted software validation tasks.
When deploying a LIMS in the lab, it is important to do so with a technology provider that has deep expertise in your field of interest, who can help you navigate the evolving regulatory landscape. Ensuring that the vendors services and support team are well versed in bioanalysis and software validation will make for a rapid time to value and ensure the long-term success of your implementation.
A more recent challenge that labs face as they adopt new technologies is protection from cyber security threats – the pharmaceutical company’s currency is intellectual property and there is a worrying trend for ransomware attacks in the healthcare industry.
It is imperative that labs work with their own and the vendors Corporate Information Security (CIS) departments to ensure that their deployments are secure employing proper data management practices, such as data encryption protocols, access control mechanisms and regular updates to security systems.
The move toward highly connected, data-driven R&D ecosystems
Moving to more highly connected and data-driven R&D ecosystems will enable drug development processes to meet the needs of today’s market. According to Fortune Business Insights, the North American life sciences software market is expected to grow over $20 billion between 2025 and 2032, reaching as much as $36.25 billion, and proving that investments in this ecosystem are on the rise as labs hope to increase efficiency, maintain accuracy and stay agile.
When implementing digital technology, it is important that lab managers set scientists up for success by considering the human aspects of change management, this begins with consultation with the staff whilst defining requirements and selecting the solution.
Managers must ensure that the users are involved in the requirements workshops and ‘stage gate’ sign off’s during development and deployment and that their expertise is brought into play during ‘user acceptance testing’ and ‘performance qualification. Ultimately this will ensure that the entire team is invested in the success of the technology deployment and that the users are well versed in the system by the time it is deployed into production.
