How an integrated LIMS platform can transform drug development and manufacturing workflows
In this article, William E Weiser discusses the advantages global pharmaceutical developers and manufacturers can gain from a laboratory information management system (LIMS) solution and highlights the key considerations to be made when integrating and standardising LIMS in their organisations.
WITH THE ongoing need to develop novel therapeutics and deliver them to patients as quickly and safely as possible, pharmaceutical companies’ operating facilities across the globe must find ways to streamline drug development and manufacturing processes, thereby accelerating drugs through the pipeline and enabling the scaling up of their capabilities to meet demand. A key element to achieving this is through effective and reliable data management integrated across all sites, helping to avoid data silos and facilitating automation, collaboration and process optimisation.
With an integrated LIMS, it is possible for pharmaceutical companies to connect multiple facilities on a single, cloud-based platform for simplified, real-time access and sharing of data across entire laboratory networks. By using an enterprise-wide, automated data management system, organisations can benefit from improved efficiencies that allow them to streamline and expand their operations.
Standardising LIMS streamlines operations and improves efficiency
For pharmaceutical companies, effective data management is vital for optimising and scaling up operations – and an integrated LIMS solution can help support this effort. The benefits offered by a LIMS include:
Elimination of data silos and improved collaboration: Most pharmaceutical companies already have digital systems in place to aid their workflows and processes, but these systems may vary across the organisation, especially for data management. Over time, it is not unusual for individual departments and facilities to develop their own systems for gathering and storing data based on their specific functions and everyday needs. This can result in data silos, which not only limit opportunities for collaboration, but can also cause unnecessary delays and inefficiencies as projects progress through various teams. If data cannot be easily transferred as a drug moves from development in one facility to manufacturing in another, it may take longer to scale up drug production, resulting in delays for patients.
An advanced LIMS implementation standardises data collection and storage procedures, minimising discrepancies when handling data. This not only eliminates data bottlenecks, but also makes it easier to transfer data from one team to the next and maintain its accuracy throughout. As a result, delays or transcription errors are avoided, speeding up the movement of drugs through the development and manufacturing pipeline.
Centralised data: To simplify data management, a LIMS solution stores data in one centralised location – a ‘single source of truth’. Doing so makes it easier to access, trace and retrieve data, which is valuable for complying with audits and meeting data integrity regulations. Proof to data adherence to ALCOA+ guidelines can be shown, ensuring it is always attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring and available.
Through LIMS, users can streamline their workflows from start to finish, while ensuring set processes are adhered to and compliance is maintained”
Pharmaceutical companies can also use an integrated LIMS platform to connect disparate data sources and display resultant collated information, such as key performance indicators, on a dashboard. Identifying trends and gaining insight from this data then becomes simple and straightforward, providing a faster and more robust decision-making process. Furthermore, centralising data allows for better data sharing, reporting and analytics through features such as vendor-neutral data formats and data visualisation dashboards that users can configure to display information relevant to them or their teams.
Automated processes: There are several routine tasks within laboratories that are frequently undertaken manually, including tracking instrument calibrations, updating records of consumables and reagents as well as keeping and managing records of authorised approvals. A LIMS automates these tedious tasks to allow scientists and researchers to focus on advancing their projects, while also lowering overheads and maintenance costs, increasing productivity and minimising error. For instance, LIMS software enables resource management by monitoring lab inventory, automatically notifying users or reordering when stocks are low. Automation of low-value tasks frees up the scientists, allowing them to accelerate drug development and manufacturing processes, which ultimately results in faster delivery of therapeutics to patients.
Standardised and optimised workflows: Using a LIMS platform, operating procedures are outlined for each process, making them easier to follow for everyone across the organisation, no matter where they are located. This facilitates standardised workflows, with steps that are consistent and reproducible across teams and departments. An integrated laboratory execution system (LES) can guide users step-by-step through SOPs, providing clear instructions via images, videos and augmented reality tools to drive quality, repeatable process execution.
Additionally, an integrated LIMS solution helps manage and optimise laboratory workflows – from sample processing to analysis and reporting. Scientists can use the system to pre-schedule routine samples, identify appropriate and available storage for samples, assign tests and specifications and produce customised labels. They can also monitor aspects of an analysis, such as instrument state and configuration and operator name and training level. Through LIMS, users can streamline their workflows from start to finish, while ensuring set processes are adhered to and compliance is maintained.
Enterprise integration and connectivity: A modern LIMS platform can connect to other instruments and existing digital systems, such as manufacturing execution systems (MES), enterprise resource planning (ERP) systems and chromatography data systems (CDS). This allows for a fully integrated experience across different departments and facilities with the use of a single solution from drug development through to manufacturing, thereby providing a holistic view of operations, enabling a seamless user experience and improving productivity.
A strong foundation for artificial intelligence (AI) and machine learning: Advanced data-driven technologies, such as AI and machine learning, can help identify parts of a process that could be optimised for speed or cost, or pinpoint areas where automation would be beneficial to allow for easier scaling up. To do that, these technologies need access to clean, systematically structured data. An integrated LIMS solution helps achieve this by capturing raw data and its associated metadata, which can then be easily extracted and presented as actionable information in a clear, concise format. With a modern data management system in place, pharmaceutical development and manufacturing organisations can leverage the benefits offered by AI and machine learning.
Making informatics a priority in the pharmaceutical industry
As discussed, using an integrated informatics platform, pharmaceutical companies can continuously improve their processes, making them more efficient with the help of automation, data sharing and optimised workflows. This efficiency, along with the greater flexibility gained from automation, affords companies the operational agility to scale their production as needed. Industry leaders looking to integrate and standardise LIMS across their organisations will need to consider several vital factors while doing so.
A key consideration is to ensure seamless transitions between legacy implementations and a new LIMS platform. Legacy instruments and laboratory-developed digital systems contain sensitive and valuable information that need to be populated into LIMS. The information will need to be carefully transferred into the new system to make sure no data is lost and avoid any inaccuracies.
When it comes to change management, teams may find it difficult to move away from systems and processes they trust and are already familiar with. To overcome this challenge, it is important to clearly communicate the value of implementing a single LIMS by describing the benefits at both the company and the department-level, conveying the day-to-day benefits specific to each team. It should also be demonstrated how the LIMS helps teams reach their goals, providing analysts a positive user experience and enabling them to spend more time on their scientific work.
Another important consideration when implementing a standardised LIMS in an organisation is employing a collaborative approach. Integration of LIMS across departments or sites should welcome input from laboratory, IT and management teams so that workflows are set up to serve each department in the most effective way possible. Organisations should also work with their LIMS partner to ensure that there are no blind spots when the system is deployed for use and that adequate support is available throughout the system’s operation.
Lastly, drug developers and manufacturers need to make sure that their informatics systems comply with regulatory requirements, such as 21 CFR Part 11 and that any newly established protocols undergo validation and testing. Choosing a LIMS solution that is designed to remain fully compliant with good manufacturing practices (GMP) and good automated manufacturing practices (GAMP) ensures regulatory standards are adhered to and maintained.
Integrating a standardised LIMS solution from drug development laboratories through to manufacturing facilities simplifies data management and sharing, increases automation and optimises workflows. These efficiencies further streamline the drug production process, ultimately allowing pharmaceutical companies to efficiently scale up their operations. Through this agility to scale, companies can more swiftly meet the demand for new therapeutics, reaching a greater number of patients and rapidly delivering drugs to those in critical need.
About the author
After receiving a doctorate in analytical chemistry, William Weiser started out his career working in the lab supporting early phase pharmaceutical development including project management and regulatory submissions. He moved to the contract analytical laboratory environment, working to create a comprehensive pharmaceutical testing and development service. Now at Pharma Services,Thermo Fisher Scientific, for the past 10 years, he has held leadership roles in pharmaceutical development, analytical chemistry and quality assurance.