Pharmaceutical manufacturing, often referred to as pharma manufacturing, is the large-scale synthesis of pharmaceutical drugs. This intricate process presents numerous challenges and requires practitioners to be well-versed in various techniques to optimise drug development. Achieving optimization in production has a direct and positive impact on a pharmaceutical manufacturer’s profitability. Several methods and tools can be employed to enhance manufacturing optimization efforts:
Digital manufacturing involves the application of digital tools and techniques to streamline the manufacturing process. This encompasses utilising data and analytics or harnessing advanced technologies like artificial intelligence (AI). These digital tools played a pivotal role in enhancing manufacturing during the disruptions caused by the Covid-19 pandemic. Industry 4.0, the ongoing automation of traditional manufacturing, has been driven by these digital tools. A report by Pharma IQ revealed that 94 percent of pharma manufacturing professionals were able to maintain operations thanks to Industry 4.0 solutions. Additionally, these solutions yielded savings of 20 percent while improving quality and reliability in deliveries.
Flexibility in the manufacturing process is crucial, especially when facing surges in demand, as seen with the rapid production of the Covid-19 vaccine. A report by Rockwell Automation titled “Critical considerations for deploying smart, fast, and flexible life sciences facilities” highlights the significance of flexible manufacturing. It can involve producing smaller batches, optimising asset utilisation, or being the first to enter a new market. The adoption of flexible manufacturing facilities is on the rise, with many pharma manufacturers recognizing the advantages of tools like single-use reactor bags, smart totes, and mobile processing equipment. These tools enable organisations to swiftly adapt their manufacturing processes to meet increased demand or shifting priorities.
Continuous processing techniques and technologies are gaining favour in the pharma industry to enhance workflow productivity. Unlike traditional batch manufacturing, continuous processing setups create a continuous production cycle with no hold times, resulting in faster development and enhanced process safety. The benefits of continuous manufacturing include reduced long-term manufacturing costs, shorter production times, and lower rates of human error.
Where to Find Pharma Manufacturing Solutions:
The Application of AI:
The use of AI to optimise the manufacturing process is gaining prominence in the pharma industry. Developing new pharmaceuticals is a complex process, with less than 10 percent of clinical drug candidates receiving approval. AI can enhance target validation and candidate quality, optimise clinical trial designs through biomarker-based screening, and reduce costs through database-trained silico methods. Furthermore, AI can help address the increasing complexity of global pharma manufacturing processes and automate mundane tasks, allowing teams to focus on high-value activities.
Data and Analytics:
To achieve digitally efficient pharma manufacturing, manufacturers must implement principles of findable, accessible, interoperable, and reusable data. Research from Pharma IQ reveals that pharma practitioners believe data and analytics will have a greater impact on manufacturing than any other trend between 2020 and 2014, signalling a readiness among manufacturers to embrace enhanced digital practices.
High-Density Cell Banking:
High-density cell banking revolutionises cell culture amplification, reducing a process that traditionally took weeks to mere days. This innovation increases cell culture density from 10 million cells per mL to 100 million cells per mL, significantly accelerating production for drugs like vaccines and therapeutics.
Optimising Manufacturing Processes:
Maximising Operational Efficiency:
Pharma manufacturers are increasingly emphasising the importance of process efficiency and cost containment to meet demands for more affordable generics and faster production. Strategies like effective change management and control, along with the application of digital solutions such as smart connected labs, can help achieve this.
Improving Pharma Water Monitoring:
Efficient production methods with stringent safety and quality standards pose challenges, especially in monitoring water usage. Real-time monitoring for microbial and total organic carbon (TOC) contaminants is essential. Leveraging efficient water monitoring solutions can streamline this process, ensuring compliance and reducing resource drain.
Applying Digital Manufacturing Solutions:
Implementing digital manufacturing tools and technologies, while beneficial, requires careful consideration due to the complexity of these solutions and the pharmaceutical manufacturing process as a whole.
The Value of Optimised Pharma Manufacturing:
Transforming the Manufacturing Process with a Digital Approach:
The adoption of digital manufacturing tools and technologies is a top priority for many manufacturers due to the numerous benefits they offer, including reduced manufacturing costs, shorter production times, and enhanced regulatory compliance.
Improving Manufacturing Outcomes with Flexible Manufacturing:
Flexible manufacturing practices can significantly improve production outcomes, resulting in a 25 percent greater yield through reduced cleaning times and better utilisation of labour. Technologies like single-use reactor bags and data-controlled processes further contribute to efficiency gains, reducing inventory needs and building footprints.
In conclusion, pharmaceutical manufacturing is a complex and dynamic field that relies on the latest technologies and techniques to optimise drug development and production. Embracing digital solutions, flexibility, and continuous improvement is essential for pharmaceutical manufacturers to remain competitive in this rapidly evolving industry.