Today, the Pharma industry is facing challenges and undergoing huge transformations. Recent events have shown the importance of stable and resilient supply chains. These disruptions have also led to immense innovation in the pharmaceutical industry, where we are learning how to be better and stay better. It was an interesting moment during the keynote session to hear Michael Kopcha, Director of the FDA’s Office of Pharmaceutical Quality, say that the key to stable supply chains is Quality. Regulations, quality management, advancement in manufacturing and getting international convergence, all define the future of Pharmaceutical Quality. A key message is that digitalization inherently fosters enhanced data integrity.
This will help us in achieving the end goal – to ensure every dose is safe and effective, giving patients the confidence they deserve.
Pharma 4.0 Industry Status
We continually hear that digitalization in Pharma lags other industries, but the 2022 ISPE survey of over 500 respondents showed that over 35% are running pilots in and taking the leap in their journey towards Pharma 4.0, which is an increase compared to 2021. In Axendia’s recently released report, similar observations were made for the 200 respondents surveyed, with 69% either piloting applications, undergoing or having completed digital transformation--much higher than two years ago. From the ISPE’s 2022 data, organizational and cultural barriers remain a challenge in digital transformation, reinforcing that the Pharma 4.0 journey is not only about technological advancements and accessibility.
It is not surprising, then, to see that data and connectivity are among the technologies being actively explored by the industry as having a connected, unified platform which incorporates data from various sources, making it readily available and accessible is key. Being able to readily access multiple sources of data saves time and allows teams to focus on getting answers to questions for better decision-making.
Trends also suggest that manufacturing (the interplay among operations, supply chain and maintenance) remains and will remain the area where most digital transformation is taking place, and with the highest potential to bring value to pharma companies. This is very likely driven by the scale at which they can impact. Quality Assurance (QA) and laboratory environments are also areas where enormous potential benefit is anticipated, notwithstanding there is a lot to be learned because these groups are not typically associated with strong IT backgrounds. As stated in the GAMP Roundtable session led by Chris Clark from TenTenTen Consulting, building comfort and confidence around IT in QA, especially with regards to AI and ML, is integral to its acceptance and adoption.
The theme of patient-centricity underscored many of the discussions at ISPE and were well-articulated by Julie Kim from Takeda and Tom J. Cheslock from Pfizer.1 Collaboration was absolutely key during the pandemic, and it will continue to be as we navigate the VUCA environment we’ve grown to accept. The common goal that the industry continues to share – the reason we fight for greater efficiency and productivity is to ultimately improve access to medicine. The pandemic became a catalyst for change and fostered innovations in laboratories, manufacturing, supply chain and logistics, and digitalization has been key in this journey as it advanced standardization, integrating processes, ensuring data integrity and effective collaboration. Each step towards digitalization creates added value across the organization; for instance, minimizing unplanned downtime will inevitably improve supply chain resiliency, as will moving from paper processes to electronic. Julie Kim cited a poignant quote from Ryunosuke Satoro, “Individually, we are one drop. Together, we are an ocean.”
Continuous manufacturing (CM) continues to be a major topic of discussion in pharma, as it is well-known to speed production, reduce footprint and waste, and it affords greater flexibility across a production facility. In addition, a detailed stochastic economic analysis (using NPV) over historical financial data showed that investing in continuous manufacturing technology is much more profitable for both brand and generic manufacturers2. In a recent analysis3, CM yielded faster time to approval and faster time to marketing compared to batch manufacturing, resulting in $100s of millions in savings. It also enables the usage of PAT in Real Time Release Testing for dynamic process control and is a gateway towards the vision of Smart and Connected factories. A reminder from Michael Kopcha was that CM does NOT pose significant barriers for manufacturing process changes or pre-approval inspections, as captured in a previous AspenTech blog, regulatory agencies are fully behind CM. Success stories presented by Melanie Dumarey from AstraZeneca and Abhishek Sahay from Thermo Fisher reinforced that these benefits are achievable. The adoption and implementation of this technology has its own challenges, which are cultural and technological. But the advent of new technologies and solutions can help accelerate this transition.
And so, the journey of advanced manufacturing and digital transformation continues — Advance your Pharma Digitalization journey with AspenTech.
2Rossi, C.V. A Comparative Investment Analysis of Batch Versus Continuous Pharmaceutical Manufacturing Technologies. J Pharm Innov (2022). https://doi.org/10.1007/s12247-021-09612-y
3Fisher AC et al An audit of pharmaceutical continuous manufacturing regulatory submissions and outcomes in the US. Int J Pharmaceutics (2022). https://doi.org/10.1016/j.ijpharm.2022.121778