Sumeet Dalvi from Emerson explains how software platforms that manage product and manufacturing specifications enable seamless and rapid technology transfers.
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The pandemic brought into sharp focus the digital maturity of the life science industry and its need to embrace digital transformation to accelerate drug development. Digital transformation involves integrating advanced technologies to create new, more efficient processes, allowing industries to adapt to evolving market demands. In the life sciences sector, where there is growing demand for faster product development and availability of new therapies, digital transformation is pivotal. By leveraging tools that capture, manage, and utilise data effectively, companies can streamline research and development, accelerate technology transfers, conduct robust risk assessments, and ensure consistent manufacturing and regulatory compliance. This enables the industry to execute tasks across the drug development pipeline with greater efficiency, reducing the time needed to bring therapies to market.
Data management
As new products progress from development through clinical trials to commercial manufacturing, an extensive amount of information defining product and process specifications must be captured and managed. This includes thousands of parameters such as equipment specifications, material details, operating conditions and quality requirements. Transferring this data, whether between development stages or facilities, has traditionally been a labour-intensive and time-consuming task. Historically, information has been stored in disparate formats – spreadsheets, word processing documents and other unstructured repositories. This disjointed approach complicates efficient and error-free data transfers. To address these complexities, a shift toward centralised, standardised and data-driven systems is essential. Digital platforms designed to consolidate and manage such data simplify the process, enabling seamless and rapid technology transfers.
Digital process knowledge management
Modern software solutions now offer centralised repositories for managing product and manufacturing process specifications. These tools replace the fragmented approach of housing data across various formats and systems by integrating all aspects of the process – steps, materials, equipment, and activities – into a unified platform. Standardisation is key to these solutions. They provide configurable frameworks for defining product specifications, enabling streamlined recipe development and scale-up processes. Scientists benefit from automation that eliminates manual calculations and verification tasks, ensuring accuracy and compliance with regulatory standards. By digitising recipe development, organisations can save significant time and reduce human error.
Digital transformation necessitates and facilitates changes to working practices. A centralised data management system enables much better collaboration on recipe development, manufacturing and technology transfers across internal teams and contract development and manufacturing organisations. A unified platform allows cross-functional teams to simultaneously access recipes, tag comments, attach documents and utilise built-in workflows to manage approvals.
Integrated approaches to process models
To further enhance efficiency, these process knowledge systems often integrate seamlessly with other laboratory and manufacturing systems, such as electronic lab notebooks and laboratory information management systems. They also support automated data exchange between various applications, ensuring that process parameters are easily transferred from development environments to production systems such as distributed control systems (DCS) and manufacturing execution systems (MES). This integration can reduce the time needed for technology transfers by up to twelve months, significantly accelerating time-to-market. Integrated systems also enhance change control, with manufacturing process parameter changes easily forwarded to the MES/DCS and automatically recorded. This eliminates the need for manual searches through documentation to create change management reports, enhancing traceability and ensuring cGMP are achieved.
Streamlining risk assessments
Standardised data management systems also play a crucial role in risk assessments, which are critical for ensuring product safety and efficacy. These assessments, required throughout drug development, evaluate the impact of critical process parameters (CPPs) on critical quality attributes (CQAs). Such evaluations are especially vital when scaling up production or transferring processes to new facilities.
Advanced risk assessment tools integrated with process knowledge systems simplify this process by centralising CPP and CQA data. These tools enable teams to perform various risk studies, such as Failure Mode Effect Analysis or Cause-and-Effect analyses, with greater efficiency and precision. They eliminate the need for manual data entry, reducing errors and saving time. Embedded change control functionalities further ensure compliance with good manufacturing practices while maintaining data integrity.
In summary, adopting digital tools for process knowledge management transforms the efficiency and reliability of drug development. By consolidating product and process data into standardised, integrated systems, companies can significantly accelerate technology transfers, enhance the accuracy and consistency of risk assessments, and simplify compliance with regulatory standards through robust change control mechanisms. These systems reduce manual work, improve data integrity, and accelerate key processes, ultimately supporting the faster delivery of life-saving therapies to patients.