Contract and development manufacturing organizations (CDMOs) are a major resource in pharmaceutical & biotech product development, not only for smaller companies lacking research and manufacturing facilities but also for large organizations needing specific expertise.
Lab information management systems (LIMS) are a key element in successful CDMOs, helping them transition to Industry 4.0 during the research and development phase, with synergies that even ease the path to manufacturing. This is particularly beneficial as the economy tightens.
The growing need for CDMOs is part of the general trends toward outsourcing. For many companies, it is an economic imperative that helps companies use their capital and their intellectual resources as efficiently as possible. It has become integral in the development and success of many life sciences companies. To that point, Absolute Market Insights valued CDMO revenues at more than $159 billion in 2022 and projected an 8% compound annual growth rate (CAGR) through 2030.
CDMOs’ most recent surge was fueled by their role in bridging the manufacturing gap caused by the need to manufacture COVID-19 vaccines and therapeutics at previously unheard-of quantities and within short timelines. That is only part of the picture, though. Non-COVID-related research, development, and manufacturing activities also grew. For example, when the Federal Reserve Bank cut interest rates to 0% in March 2020, investment capital poured into biotech. CDMO valuations soared. Reported profits for public CDMOs ranged from 10% to 20% through mid-2021.
Economic indicators for 2022, however, are not as bright. The initial public offering (IPO) window is all but closed, interest rates are rising, and stock prices are plummeting. Biotech company valuations are slumping. Economists are discussing a recession.
To thrive in such an environment, CDMOs must operate with extreme efficiency.
That entails embracing the data-driven research and development that is part of Industry 4.0. Advanced analytics, including lab information management systems (LIMS), is a key part of that.
When applied organization-wide, digital informatics enables a comprehensive view of operations, deep insights, greater control, and on-the-spot reports that include trends, certificates of analysis, condition reports, and periodic reports. Consequently, organizations have the data needed to make real-time improvements to operations and products. For example, one lab found that by using a LIMS, overall data quality improved and the time spent entering and retrieving data was reduced. By expanding access to the data, it also found that researchers gained novel perspectives.
That is because data stored in a LIMS is never buried in inaccessible silos or updated in one database but not another. Instead, LIMS integration makes data, including inventories, experiment results, issues, and reports accessible system-wide instantly. As a result, issues can be addressed, and product development can advance with everyone working from the same source of truth. This enables fast knowledge transfer that speeds process development and contributes to a streamlined, iterative approach to therapeutic development.
Because reports can be generated from master data within the LIMS, the need for manual data input is reduced. Accuracy, therefore, improves.
This wide-scale digitization creates an audit-friendly environment that supports regulatory filings. The key is the accurate and easy report generation that emanates from a sole source of truth. Therefore, the data-gathering, report-generating aspects of the investigational new drug (IND), new drug application (NDA), biologics license application (BLA), and other filings are significantly streamlined. Applications can be filled faster and easier, and with the exacting data integrity that regulators demand.
Initially, for CDMOs, LIMS’ most notable features may be their ability to integrate instruments into the system and then automate manual processes, procedures, and tasks throughout the research and development phases. This includes equipment maintenance and personnel training records. As a result, managers know whether individual staff members are properly trained on specific procedures, instruments, and equipment and whether instruments and equipment are properly calibrated and maintained and, therefore, whether they can be used with confidence.
Most individual lab instruments are used for drug development support integration, either through internal applications, third-party software solutions, or application programming interfaces (APIs). The level of integration can be one-way (from the instrument to the LIMS) or bi-directional, to support such activities as batch setups, automated instrument calibration, instrument control, or decision-making.
LIMS do more than track experiment results, projects, or inventory, of course. They also can identify researchers on a given project, identify next steps, improve workflow, alert users to important dates in schedules or inventory levels, inform users regarding proper sample storage and instrument use and analyze any laboratory backlogs. With these capabilities, CDMOs can gain insight into their labs’ efficiency and use that knowledge to make improvements.
LIMS also can perform – or link to solutions that perform – scientific calculations, thus removing another potential error source. Other capabilities include automating testing analysis and tracking trends, thus freeing staff for more value-added activities. With such wide-ranging capabilities, managers can establish management-by-exception protocols so quality assurance professionals need only review data that falls outside specified parameters, further enhancing productivity.
These systems can further slice and dice the data by generating reports based on the instrument, project, client, or lab technician. This data can then be used to balance or prioritize workloads as new projects and activities are considered.
On the manufacturing side, manufacturing systems and learning management systems can be integrated into LIMS. This may be particularly beneficial as projects scale from the bench to the manufacturing suite, enabling a broader view of the development and manufacturing environment for a given product.
Throughout development, LIMS make it possible to leverage both immediate and predictive analysis to better transition to the next step in a drug’s design and development. By leveraging the vast quantities of data available through an integrated LIMS, predictive models can be more accurate than those developed otherwise. A variety of visualization methods helps users consider it in many ways and present it effectively to various audiences.
Because data and reports can be accessed from one dashboard, data visualization may be more comprehensive and project workflow management may improve. Depending on the LIMS chosen, even some business and accounting systems can be integrated into the system to support lifecycle management.
When it is time to transfer development to other facilities or back to the client, having a robust LIMS aids the process by ensuring that the new facilities have all the supporting documentation for the process or product, both current and historical. Having thorough, well-organized digital processes in place has become a competitive advantage for CDMOs, helping them attract clients by reducing product variability and improving quality, and by smoothing tech transfer.
For CDMOs, the digital infrastructure and manufacturing infrastructure go together. It takes both to develop and manufacture therapeutics of consistently high quality that meet the requirements of the FDA and other regulators. By providing a thorough data-based history throughout a drug’s development, LIMS systems help position life science companies for success.