Advanced Manufacturing in Pharma

Advanced Manufacturing in Pharma: Revolutionizing Production Efficiency and Quality

Have you ever been left feeling helpless when you desperately require a specific medication, but it's nowhere to be found? Unfortunately, the pharmaceutical sector is not exempt from such challenges, particularly in light of the pandemic's disruptive effects. Advanced manufacturing in pharma seeks to tackle these issues by increasing efficiency and consistency in pharmaceutical production.

Developing Strategies for Advanced Manufacturing in Pharma

Pharma 4.0: A Game Changer in the Industry

Pharma 4.0, a term introduced by the ISPE, is a framework focused on enhancing pharmaceutical production. This concept has its roots in Industry 4.0, which has benefited other sectors with innovative approaches. The FDA's Advanced Manufacturing Initiative also addresses these challenges, promoting novel medical product manufacturing technologies that improve drug quality, mitigate medicine shortages and accelerate global access to medicine. A notable shift is the transition from batch to continuous manufacturing.

Continuous Manufacturing: A Step Forward

In contrast to the traditional batch manufacturing process, continuous manufacturing maintains a steady-state production where raw materials are incessantly fed and processed to generate finished products. This method typically offers a smaller equipment footprint, a higher production rate, and more consistent product quality. The FDA uses the term "semi-continuous" for a continuous process that only needs to run intermittently to meet product demand.

The Technolgies Fueling Advanced Manufacturing in Pharma

Advanced Manufacturing and Pharma 4.0 initiatives are driving the pharmaceutical industry to adopt new technologies that enhance quality, efficiency and resilience in production. Some of these innovations include:

• Advanced Process Analytical Technology (PAT): PAT implements practical changes in production to increase yield and throughput while minimizing failed batches. It enables rapid mapping of the process design space, accelerates the shift from batch to continuous manufacturing and supports real-time release testing (RTRT) for faster response to demand fluctuations.
• Manufacturing Execution Systems: Despite the benefits of continuous manufacturing, batch processes remain crucial in pharma due to the need for equipment flexibility across various products. AspenTech's suite of tools, such as Aspen Production Execution Manager™ and Aspen Production Record Manager™, enables efficient management of batch execution, record archiving and validation, leading to significant reductions in manual data entry, batch cycle times and time taken for batch release.
• Supply Chain Planning and Scheduling: Digital technologies like Aspen Plant Scheduler™ ensure efficient adaptation of production schedules in response to shifts in supply and demand. These technologies also consider carbon emissions and sustainability when determining optimal schedules, enabling a digital transformation in pharma.
• Predictive Maintenance for Pharma: Machine learning models in predictive maintenance technologies, such as Aspen Mtell®, offer early warning signs of equipment degradation, allowing maintenance teams to plan interventions that minimize or avoid production disruptions and reduce costs associated with unnecessary maintenance.

Make Advanced Manufacturing in Pharma Possible with AspenTech

AspenTech has accumulated over four decades of experience in innovation and collaboration with pharma adjacent industries to enhance manufacturing processes, providing solutions that assist with the industrial digital transformation and catalyze Pharma 4.0 initiatives. Our cutting-edge solutions, including the renowned modern Process Analytical Technology (PAT) solution, enable seamless integration of continuous manufacturing, boost quality, yield and throughput. As a result, we help integrate efficiency, resiliency and software for sustainability into all aspects design, production, and quality assurance.

• Aspen Production Execution Manager™ (APEM). Now available with a sleek and modern web interface, APEM, allows for effortless configuration of batch recipes and close management of their execution. This is achieved through seamless integration, guidance, and monitoring of both human and machine execution during every step of the recipe.
• Aspen Production Record Manager™ (APRM). APRM allows organizations to organize and archive all time-series data, summary features and timing data associated with batch execution, which is typically stored in the Aspen InfoPlus.21® historian. The highly efficient database schemes employed by APRM enable seamless search, retrieval and organization of data for all historical batches that meet user-specified criteria. These technologies empower workflows and reduce manual data entry time by up to 95%, cut batch cycle times by 20% through more efficient turnarounds and decrease the time taken for batch release by 60%.
• Aspen Plant Scheduler™. Aspen Plant Scheduler provides an agile adaptation of the production schedule, allowing for effective responses to daily shifts in supply and demand. Plant digitalization means schedules are automatically adjusted, considering near and long-term planning and scheduling priorities to achieve optimal tradeoffs. Additionally, realistic assumptions are integrated into the schedule to ensure consistent on-target delivery.
• Aspen Mtell®. Aspen Mtell leverages machine learning models to offer early detection of equipment degradation, including mapping to known failure modes. This capability allows maintenance teams to plan maintenance interventions proactively, minimizing or preventing production disruptions. The solution also eliminates unnecessary equipment maintenance costs and associated risks.

FAQs

What is Pharma 4.0?

Pharma 4.0 is a framework introduced by the ISPE that focuses on enhancing efficiency and consistency in pharmaceutical production by adopting innovative approaches and technologies.

How does continuous manufacturing differ from batch manufacturing?

Risk-based maintenance allocates asset maintenance resources according to the cost of failure of the asset. Risk-based maintenance weighs the costs of manufacturing downtime against the cost of maintaining and servicing equipment to provide a more intelligent division of attention and effort.

What are the key technologies fueling advanced manufacturing in pharma?

Some of the key technologies include Advanced Process Analytical Technology (PAT), Manufacturing Execution Systems, Supply Chain Planning and Scheduling, and Predictive Maintenance for Pharma.

How does advanced manufacturing in pharma contribute to sustainability?

Advanced manufacturing in pharma improves process efficiency, reduces waste and optimizes supply chain management, which collectively contribute to the digital transformation in pharma, reducing the industry's carbon footprint and enhancing sustainability.