Specifically, transformations of facilities, laboratories, equipment, and operations with the goal to unlock the full potential of internal and external data by capturing, structuring, connecting, and analyzing these across process development and clinical and commercial manufacturing, have demonstrated increased efficiencies in technology transfers, facility, equipment and process validation, operational readiness, manufacturing process development, and manufacturing deviations troubleshooting.
Based on industry benchmarks, there is immense value in the digital transformation of operations. For example, by transitioning from paper records, excel-based data collection and analysis to a findable, accessible, interoperable, reusable, and contextualized data framework with clear data governance, data architecture, data quality/compliance and ontologies.
Moving from paper-based batch records to fully electronic batch record management and execution systems can greatly enhance the ability of an organization to collect, transform and utilize data. Advanced data analytics and modeling capabilities are added if process, equipment, and product quality data are also collected electronically and connected with the executed electronic batch records. Finally, the use of a centralized and cloud-based data platform ecosystem into which all data are ingested allows the holistic understanding, definition, analysis, and utilization of a process control strategy. For example, the data can be used by CMC project teams, facility engineers, or development/manufacturing technical experts to enhance program oversight, investigate and solve manufacturing challenges, ensure operational readiness and validation success, monitor product quality, and support regulatory submissions. Additionally, the database can be leveraged as a source of ‘prior knowledge’ for next generation drug development programs, facility builds, technology transfer, and equipment validation, and support detailed modeling initiatives, including at the unit operation level.
The cornerstone of a digital transformation is the appropriate selection of equipment/IoT sensors, adequate data capture hardware and software, and user-friendly data platforms. Of critical importance is the upskilling of all employees, such as engineers and technicians, tasked with building these systems and the CMC process, analytical, and quality subject matter experts, who are the end-users of these data.
Working with data requires different capabilities and skills. Roles such as data analyst, data engineer, and data scientist, are becoming increasingly important and sought after by both innovators and service providers in the industry. These are only a few roles which may be needed to enable the above-mentioned digital transformation. It is critical that the biopharma and biotech industry seeks to develop, recruit, and retain individuals in these areas to enable successful digital transformations.
However, demystifying digital, data and all related activities is a very first step when starting this transformation journey. Giving access to awareness campaigns and customized trainings is key to successfully onboard the organization. Also, future ways of working, operating models, new roles, and technologies need to be explained and introduced in tangible use cases, while working in an agile mode as defined in the agile manifesto to allow a structured learning environment which allows to include learnings into the next steps and increases the overall digital and data maturity.
An area of focus of the 2022 ISPE Biotechnology Conference is digital transformation. One of the morning sessions on Wednesday, 29 June will be “Enabling Digital Transformation in Biotech” led by Phil Smith (GSK), Michelangelo Canzoneri (Merck KGaA Darmstadt), and Prudence Edwards (engineering student and ISPE Emerging Leader).
The education agenda will also feature four case studies illustrating digital transformation at the facility and manufacturing process levels. The presentation from Honeywell will discuss the digitization and integration of manufacturing equipment; AstraZeneca will present predictive computational modeling of manufacturing processes; AspenTech will talk about the application of a digital twin framework for a chromatography unit operation; and CRB will describe how digitization and automation can lead to Pharma 4.0™ success.
We look forward to connecting with you all in Boston for these industry-critical discussions!