Kelly Doering, senior director, Industry Marketing, Pharma, at AspenTech looks at five key trends that will inform the pharma market in 2022.
As we move into 2022, the future for pharmaceuticals is focused on how companies leverage automation and the latest digital technologies to drive process improvements. Several key areas are top of mind for decision-makers across the industry. Here we focus on five of the most important.
Continued drive for faster time to market
The speed at which pharmaceuticals companies developed and brought new Covid-19 vaccines to market in 2021 was widely celebrated. Throughout 2022, manufacturers will focus on developing a more efficient production cycle to support speeding up the industries time to market for all medicines. The objective will be to ensure quality, automate time-consuming processes, reduce risks, remove unplanned downtime and prevent bottlenecks. To support this vision, pharmaceutical companies are increasingly turning to a digital workflow powered by Industrial AI across planning, scheduling, production and asset management.
Quality control is alive and well
Automation and analytics are driving more innovation in delivering quality across pharmaceuticals. For example, using Quality by Design (QbD) principles and process analytics, manufacturers can monitor critical quality and performance to ensure final product quality within a compliant environment. Advanced Process Analytical Technology (PAT) is key to this. PAT is the implementation of at-line and in-line advanced measurement systems to provide full visibility of critical process parameters and their effects on the critical quality attributes. PAT is a powerful enabler for QbD, which helps ensure product quality through judicious process design, monitoring and control. Such are the benefits that we’d expect to hear much more about both PAT and QbD during 2022.
Manufacturers will focus more on transforming continuous processes
With much discussion about the benefits of moving from batch to continuous manufacturing for improved quality, throughput and yield, it is important manufacturers put the right technologies in place to optimise the latter approach. Process performance monitoring becomes a network of online models supervising desired operational indicators and key performance metrics. The models will provide automated 24x7 insights and propose adjustments for continuous processes. At the same time, batch control solutions are emerging that can predict batch results and anticipate deviations from target and automate corrective action, enabling more consistent efficient operations.
The time is now for more focus on traceability
Electronic batch record (EBR) systems will drive benefits across pharmaceuticals during 2022. They contain the logic and rules that enforce the manufacturing workflow. They improve data integrity, minimise error, enable efficient batch review by exception, reduce paper and manual entries and capture contextualised data to power industrial AI and advanced analytics. Audit trails, electronic signatures and documentation needed for compliance are part of the feature set.
The use of real-world data will have a greater impact on decision-making in pharma
Pharma companies have been seeing the benefits of aggregating and analysing real-world data from a variety of sources, including gaining insights that will help them improve the development and commercialisation of safe and efficacious drugs to the marketplace. Bringing data together with real-world evidence that informs the next therapeutic, the next set of criteria for a clinical study population or to better apply learnings from post-market surveillance data requires powerful digital and analytics tools to enable this. We expect these tools to be even more widely used in the industry in 2022.
The pharmaceuticals sector remains in a state of flux. Many trends will come to the fore in 2022 but the key focus areas above are likely to be among those top of mind for decision-makers across the industry.