A digital process revolution
Perhaps no industry felt greater urgency to accelerate operations during the COVID-19 pandemic than the pharmaceutical industry. The global need for large quantities of vaccines required a near revolution in vaccine development and manufacturing processes. Countless lives depended on record-breaking time-to-market adaptations in the industry—what might have taken a pharmaceutical company as long as ten years in pre-COVID-19 conditions took under just one year. Some industry professionals expect certain adaptations in the industry are likely here to stay.
The digitalization of process development
The remarkably swift development and manufacturing of COVID-19 vaccines is thanks in no small part to the digitalization of process development in recent years. Process development (PD) in the pharmaceutical industry now involves more data-driven decision-making and risk assessment than ever before. Under new process development models, companies leverage more data, automation, and modeling to reduce risks and to establish a holistic, transferable control strategy (see Figure 1).
Traditionally, pharmaceutical companies conduct hundreds of experiments at different scales to verify the efficacy and safety of a product before reaching a pilot plant scale. Only then will a product be transferred to commercial manufacturing. However, in response to vaccine demand, pharmaceutical companies have switched from batch manufacturing to continuous manufacturing. Continuous manufacturing speeds up development by allowing companies to conduct more experiments in a shorter period than is possible with batch manufacturing. They’re putting generated process data to work.
Virtual inspections with remote data access
The more complex the production process is, the more valuable process data becomes. Companies use statistical tools to understand Critical Process Parameters and Critical Material Attributes and how these affect Critical Quality Attributes. Generated process data is essential to ensure that the final product is meeting the specifications of the Critical Quality Attributes. Pharmaceutical companies synthesize small molecule drugs in chemical reactors and then formulate it in an oral solid dosage process into tablets or capsules. This can take just five days of manufacturing time from start to finish, but with wait times for testing and approvals, intermediate steps, and packaging, manufacturing can take as long as 300 days.
Large molecule drugs, like those used for vaccine production, are even more complex. They use biological processes, often in cell culture, to replicate. For example, since the 1940s, every year the United States produces millions of flu vaccines from fertilized hen eggs injected with the flu virus. For large molecule drugs, final product complexity makes it difficult to characterize detail for every batch, so large molecule drugs often requires time-consuming tests. Companies can use process data to speed up release procedures before final testing confirms the product’s quality. Increasingly, companies are using digital technologies to conduct inspections virtually with remote data access and analysis. For example, Merck has digitized their process development, allowing for remote operations and improved knowledge management.
Taking risks to shrink development cycles
Before the COVID-19 pandemic, pharmaceutical companies typically ran process steps in a series, often taking eight to ten years in a development cycle. Today, with government support and investments into the research, development, and manufacturing processes, companies took higher risks to execute many steps in parallel. This means that companies were producing vaccines before receiving approval to supply the market. Parallel operations and testing made it possible for pharmaceutical companies to deliver new, safe vaccines to the market in less than one year.
Accelerating production capacity
During the last few months, several vaccines have been approved for use in many parts of the world: AstraZeneca, Moderna, Pfizer/BioNTech, and Janssen’s single-dose vaccine. Widespread supply in record time depended on collaboration between pharmaceutical companies and contract manufacturing organizations (CMOs) to accelerate production capacity. When a company partners with several CMOs, the production rate can be substantially higher, as illustrated in the slope of the curve in the picture above.
Digitalization is bringing about a revolution in the pharmaceutical industry as process data becomes the new industry norm. Industry time-to-market is shorter than ever, and development cycle times are shrinking. This makes the industry better able to rise to the challenge of meeting global health needs as they occur, meaning a safer, healthier future for all.