The COVID-19 pandemic sparked a push for digitalization across industries. In the pharmaceutical industry, demand for automation continues to grow at a rapid pace as companies fully embark on their digital transformations and leverage the latest technologies to gain ground in competitive markets. With an eye on the pharmaceutical industry’s future, decision-makers now need to consider several opportunities as they navigate their transformation journeys.
1. Doubling down on speed to market
Over the last two years, pharmaceutical companies developed and brought new COVID-19 vaccines to market at an unprecedented pace. This was widely celebrated, and the industry is already experiencing continued demand for quicker production and delivery to market. Going forward, pharmaceutical processors will remain focused on developing a more efficient production cycle to promote faster time-to-market for all medicines, with the goals of ensuring quality, automating time-consuming processes, reducing risks, removing unplanned downtime and preventing bottlenecks. To achieve these goals, pharmaceutical companies will rely on digital workflows powered by industrial AI across the entire production lifecycle — from planning and scheduling to production and asset management.
2. Prioritizing quality control
Automation and analytics are powering the drive for quality across pharmaceuticals. For example, using Quality by Design (QbD) principles and process analytics, pharmaceutical processors can deliver higher quality final products, ensuring compliance while also monitoring quality and performance. The key is Advanced Process Analytical Technology (PAT), which is the implementation of at-line and in-line advanced measurement systems to provide full visibility of critical process parameters and their effects on critical quality attributes. This powerful enabler of QbD helps guarantee product quality through product design, monitoring and control. The benefits from PAT and QbD are proving to be trends that the industry is already seeing at the start of 2022, and they will continue to drive industry conversations moving forward.
3. Transforming continuous processes
While moving from batch to continuous manufacturing promises improved quality, throughput and yield, pharmaceutical processors must also embrace the right technologies to optimize a continuous manufacturing approach. Process performance monitoring becomes a network of online models that oversee desired operational indicators and key performance metrics. These models deliver continuous, real-time insights and suggest adjustments for continuous processes. Simultaneously, batch control solutions are emerging, helping pharmaceutical manufacturers predict batch results and deviations as well as automate corrective actions to facilitate more productive operations.
4. Renewing the focus on traceability
Electronic batch records and automated systems for product release contain the logic and rules that support the manufacturing workflow. These systems enhance data integrity, reduce errors, provide efficient batch review by exception, minimize manual paper entries and contextualize valuable data to power industrial AI and advanced analytics. Moreover, with these systems, pharmaceutical manufacturers also gain access to compliance features, such as audit trails, electronic signatures and documentation.
5. Making decisions based on real-world data
For pharmaceutical companies, collecting and analyzing real-world data from a variety of sources produces a level of insight that enables companies to improve both the development and commercialization of safe and effective drugs in the marketplace. Combining data with real-world evidence has the power to inform the next set of criteria for a clinical study population or enable companies to better apply learnings from post-market monitoring and surveillance data. But to achieve this, pharmaceutical companies must lean on powerful digital and analytics tools.
Although there are many trends already emerging this year, the pharmaceuticals sector remains fluid. For companies looking to kick-start automation initiatives or embark on digital transformation, these five opportunities represent potential priorities for the year ahead — and key mile markers on the road to transformation.
Kelly Doering leads the marketing team for the Pharmaceuticals Business Unit at AspenTech and has held numerous roles in product management, technical marketing and business development since 2007. She completed a postdoctoral fellowship at Boston Children's Hospital and holds an MS and PhD in Nutritional Sciences & Molecular Biology from the University of Connecticut, and a BS in Health Sciences and Natural Sciences from Worcester State University.