by Tom Lillig, Vice President, General Manager, Software Informatics Division, Agilent and Paul Hofstadler, Vice President, General Manager, Digital Services Enablement Division, Agilent
The demand for faster turnaround times and quicker results in the pharma and biopharma space has been a key challenge for many laboratories. According to an Agilent survey of global pharma lab leaders conducted before the pandemic, 83% of respondents stated that their processes required optimization to keep up with demand.1 This pressure was intensified by the pandemic, which accelerated the digital transformation of a wide range of industries, including healthcare and life sciences.
As a result, there is a growing expectation that drug research and development (R&D) should now be able to be achieved at an advanced rate, but this adds additional operational stresses on laboratories and potentially other stakeholders associated with getting a drug product through to the market. Fortunately, advances in lab automation and digitization are resulting in significant improvements across the pharmaceutical industry. An exemplary area where this can be seen is the development of novel drug candidates.
Another critical consideration is the collation of large, generated datasets, which can now be processed with applications supported by artificial intelligence (AI) and machine learning (ML) tools to generate insights. This same data can also be used to ensure compliance and create the documentation required in a heavily regulated environment. It also enables sophisticated asset performance management techniques that ensure scientists have the instruments available that they need and also enables lab operational and financial optimization.
The Benefits of Advanced Digitization
The two years of the pandemic put pressure on pharmaceutical companies worldwide, including Hetero Group, which rapidly discovered the benefits of advanced digitization. The company is engaged in developing, manufacturing, and marketing high-quality chemicals and biologic medicines across various therapeutic areas. It is also one of the world’s largest producers of active pharmaceutical ingredients (APIs).
Hetero Group teams are involved in analytical R&D, the validation and identification of molecules, and the quantification of impurities using ICH Q3D guidance, which promotes a risk-based approach to assessing the presence of elemental impurities in drug products. Because of its work with a wide range of verticals, Hetero Group regularly works with large data sets generated by multiple lab complexities and processes.
Fortunately, the benefits of digitization are available across a wide range of applications, from data analytics and predictions to the automation of manufacturing and production processes.
“The pandemic taught us a decade’s lessons in just two years,” explains Dr. Yogeshwar Reddy, Hetero Group’s senior vice president of Analytical R&D. “It’s very clear for the pharma sector that the digitalization of labs is going to be the future for a number of reasons, including streamlining processes, simplifying compliance, and enhancing data security.”
In the field of R&D, digitalization helps deliver easy compilation and visualization, as well as operational efficiencies. It has also helped Hetero Group to improve its audit processes, deliver high-accuracy data presentations, and create detailed audit trails.
Reddy explains, “For example, the integration of a system with ECM has not only helped us maintain data integrity and security, but it has also ensured data is available for easy reference and compilation, with high accuracy. Server-based compliance brings everything under one umbrella and helps establish transparency of processes and accesses, which is of the utmost importance.”
Enhanced Instrument Utilization
Genentech is a leading biotechnology company that conducts R&D into discovering and developing medicines for people with severe and life-threatening diseases. Advanced lab digitization has enabled Genentech’s teams of scientists to increase lab efficiency and productivity. For instance, its current workflows offer increased instrument uptime and enhanced utilization due to predictive maintenance and data and equipment monitoring tools, according to Chris Wu, Procurement Sourcing Manager, Lab Equipment and Maintenance at Genentech.
“The service data from an instrument has proved extremely beneficial in better decision-making,” he remarks. “This is vital given that the pandemic proved how a robust lab equipment maintenance strategy is key in keeping labs up and running.”
Wu added, “Critical instruments need full coverage, and redundant or backup systems should be moved to a time and materials strategy. Additionally, understanding which group each instrument falls under, through our instrument database, has kept all the important instruments up and running with ease.”
Improved Scientific Outcomes in the Pharmaceutical and Life Sciences Industry
Hetero says that innovations in analytical instruments have delivered additional benefits, such as early maintenance feedback about instrument health and faster cleaning and maintenance. However, the most significant benefits have been around data collection.
“Aided by digitalized lab systems, we can make decisions more efficiently,” explains Reddy. “This is because the data from different instruments can be comprehensively combined to help scientists better understand the drug discovery process. We can now do quantitation and identification of trace-level impurities by liquid chromatography-mass spectrometry (LC/MS), gas chromatography-mass spectrometry (GC/MS), and nuclear magnetic resonance (NMR).”
Genentech adds that increased instrumentation uptime has resulted in positive patient outcomes due to the added confidence in the availability of the instruments and the ability to run samples at any time, for as long as needed. Genetech teams have seen a specific increase in technology within the mass spectrometry and liquid chromatography space.
The Benefits of Technical Innovations
Hetero has been using Agilent’s high-performance liquid chromatography (HPLC), liquid chromatography with tandem mass spectrometry (LC/MS/MS), and gas chromatography with tandem mass spectrometry (GC/MS/MS) for some time now and has witnessed a wide range of improvements to both software and the operations over the years. These have led to significant advances in business outcomes. As a result, the use of LC/MS/MS and GC/MS/MS has become necessary for Hetero Group’s labs and is no longer just an orthogonal technique.
The company highlights that another area where it has benefitted from evolving technologies is targeted disease therapeutics, where it principally deals with large molecule applications. Smart technologies and analytical techniques make the highly complex journey of Certified Quality Auditor certification more straightforward.
Anticipating the Future of Pharma
Reddy says that a shift to complete digitalization cannot be achieved in a few months. This is due to concerns about costs, the prediction of improved ROI, and a need for general acceptance across different industry verticals. These adaptations will take time to adopt, despite their importance. Complete digitalization will also need close teamwork between the company and technology providers.
Genentech shares similar concerns about the difficulty of committing limited capital budgets to an unknown technology. This is primarily due to cost centers being tied to depreciating assets over the next 10 years. Wu foresees a solution; he suggests changes to traditional capital lab equipment purchases.
“Perhaps a move to a subscription-based instrument usage, with shorter terms, will push the industry to adopt new technologies much faster,” he says.
A key aim for Hetero is to apply predictive analytics in scientific data and include automation in its workflows. Its teams have already jumped the hurdle of data integrity and employing smart analytical instruments; they are now looking forward to using GC technology.
Tom Lillig, vice president and general manager of Agilent’s Software Informatics Division, acknowledges that “The shift to complete digitization will not occur overnight. Technology companies such as Agilent need to collaborate with key customers to prioritize delivery of the most valuable components first.”
For example, aligning on common data and communication formats across instruments and software ensures that customers do not have to translate the instrument data for collaboration across labs. Additionally, saving instrument data to the “cloud” so that customers can easily access it is a common way to run data analysis instead of spending valuable time trying to figure out how to access and extract the data.
Lillig added, “Meanwhile, to enable future phases, Agilent is working on solutions such as virtual control of instruments, smart wearables to control lab components, and other mechanisms to help enable fully automated labs.”
Delivering Timely and Accurate Results
“Lab managers also seek to derive insights from instrument data that extends beyond enhancing their need for insight into the experiments they run,” says Paul Hofstadler, vice president of Agilent’s Digital Services Enablement Division.
“Agilent has invested heavily into technologies that enable lab managers to better understand the health of their lab instruments, and interactively schedule service and maintenance events to minimize lab disruption. Bringing inventory, service history, and real-time instrument status to the lab manager’s fingertips helps us collaborate more closely with lab managers to provide them with reliable, efficient, and effective lab capabilities,” Hofstadler added.
Digital lab proficiencies will continue to be central to delivering timely and accurate research results and accelerating lab performance. These will continue to be instrumental in supporting researchers in the pharmaceutical industry at organizations such as Hetero Group and Genentech as they carry out potentially life-saving research that improves, most importantly, patient outcomes and business performance as well.
References
1. Pharma Lab Leaders Survey Reveals Key Focus Areas (agilent.com)