Data-driven decisions within lab operations in the quality and compliance space using lab informatics have become even more critical over the last few months. Companies who are equipped to access and act on data, have a competitive advantage and across both big and small pharma and biotech. We will explore how advanced analytics and digital solutions are becoming game changers in this data-driven world by exploring the following three topics in more depth:

1. Improving Cross Functional Data Management in the R&D and Commercial Space,
2. Applying Manufacturing Best Practices, and
3. Lab Automation and Digital Transformation.

Improving Cross Functional Data Management in the R&D and Commercial Space

COVID-19 has limited the live interaction between quality control and quality assurance teams in the laboratory, therefore the integration and management of data is essential for operational efficiency and traceability. We will explore the steps to transform from current state to the digital future state and why lab informatics is critical in both the R&D and commercial space.

The first step is assessing all laboratory assets. This allows companies to have better control of their data, but it is also where the most gaps are found. Many companies operate with independent legacy data systems, lacking the correct data platforms to integrate, ultimately leading to standalone data tools, lack of continuity, increased cyber security threats and lack of operational harmony.

The next step to digitize is optimizing your systems and utilizing the correct tools to consolidate your data; consider factors like the volume of data, number of disparate systems producing data, number of teams who should be accessing that data, and how fast the data needs to be distributed and updated when choosing the tools to store, process, and distribute data. More strategic top-down driven initiatives allow for centralized data management platforms and aggregate data from various data sources. It is important to accelerate data sharing across internal teams but also with external networks, such as contract labs and contract manufacturers.

However, the final and future step is to have integrated end to end systems such as LIMS (Laboratory Information Management System), CDS (Chromatography Data System), LES (Laboratory Execution System), ELN (Electronic Laboratory Network), SDMS (Scientific Data Management System). Data fabrics (a single environment consisting of a unified architecture and services or technologies running on that architecture) are being leveraged to weave together existing data management systems, while data share and capture is happening more automatically between instruments, vendors, and external contractors. Introducing transparency between all parties and digital integrations will allow for enhanced lab operations: including more efficient testing, fewer deviations and quicker root cause analysis, improved lab resourcing and sharing of results across labs, managing product between sites and visibility into production timelines and flow.

In the R&D space, many companies are looking to move infrastructures to the cloud as increases in data sharing will enable lab informatics and speed discovery. COVID has changed the speed of drug development and the industry has shown they can do it faster.

In the commercial space, the need for increased digital capabilities and shared data platforms is even more important when staying competitive in the commercial pharmaceutical market, to allow for faster market response, a single source of truth, and streamlined collaboration between cross functional teams.

Applying Manufacturing Best Practices

Quality Control labs can and should apply the best practices that have been used when digitizing manufacturing processes.

Enhanced Reporting Dashboards

Configurable and real-time dashboards and reports allow lab analysts and managers to stay informed about daily operations, view data across multiple systems, and analyze operational KPIs. These dashboards can highlight testing status and display potential options for reducing unnecessary testing. They also allow for streamlined data and drill down options for further investigation to help laboratories drive change and performance using real data, without needing to ask IT for help.

Self-Serve Data Platforms

Trends of increased self-management and use of agile manufacturing processes are being applied in the QC space. Daily scrum meetings are being replaced with daily dashboards, analysts are reporting their sample and test status throughout global LIMS systems, and data reviewers can complete their work remotely. Analysts are completing their tasks more independently and therefor have more accountability for their work and this is contributing to seamless handoffs between groups.

Lab Automation and Digital Transformation.

Due to limited staff onsite and increased testing/sample throughput, COVID-19 has been a driver of investment in lab informatics and lab automation. We see our clients exploring ways to embrace and implement automation in the labs and explore digital manufacturing/ lab enablement.

Predictive Analytics

There are many opportunities to leverage AI and lab management to help improve lab scheduling and enablement, whether it is proposing or adapting workload and demand or predicting hour by hour staff needs. Labs are deploying networks of IoT devices and sensors allowing companies to respond in real time and predict future needs. Labs are able to respond to potential issues in minutes and allowing for more efficient laboratory operations.

Automating Sample Management

Demand for samples and testing is ever increasing and with limited staff onsite, the need for automation is becoming necessary for our clients to meet their demand. Robotic automation is being used to increase sample throughput and many clients are leveraging automated assay workstations. Samples are now being processed at all hours of the day, throughout the weekends, increasing flexibility and improving processing time for analysts.

Virtual Lab Compliance

Virtual reality is another tool that is being used to help labs to stay in compliance from a training and audit perspective. Client are leveraging technology, such as Thermo Fisher’s AuditUtopia to streamline and support virtual audits and companies are enabling training through Google Glasses to provide “hands on” training at the lab bench.

Quality organizations should continue to explore ways to expand data management capabilities, learn from the success on the manufacturing floor, and leverage automation to increase productivity at the lab bench and improve decision making at the leadership level.

References:

• https://www.pharmtech.com/view/manufacturing-personnel-try-out-smart-glasses
• https://www.europeanpharmaceuticalreview.com/article/132777/from-simple-automation-to-smart-labs-the-future-for-drug-discovery/
• https://www.contractpharma.com/issues/2021-01-01/view_features/business-intelligence-for-and-from-the-lab/
• https://www.technologynetworks.com/informatics/articles/eln-lims-cds-les-whats-the-difference-313834
• https://www.contractpharma.com/issues/2021-01-01/view_features/business-intelligence-for-and-from-the-lab/
• https://www.bio-itworld.com/news/2021/01/07/trendspotting-what-s-coming-for-bio-it-in-2021