Embracing the Power of Automation Design in Pharmaceutical Manufacturing by Ruben Pedroza, Director of Automation, Genesis AEC

When establishing or expanding services to support new drug development, pharmaceutical and biotech companies find that automating their processes increases efficiency, maximizes capital, reduces costs, and expedites time-to-market.

The life sciences industry is rapidly evolving. Pharmaceutical, biopharmaceutical, and biotech companies are shifting priorities in order to increase efficiencies and accelerate timelines to commercialization for potentially life-saving therapies and technologies. This momentum is driving unprecedented growth in the life sciences sector.

Genomics and precision medicine are currently among top trends in drug development,1 with more than 3900 cell, gene, and RNA therapies cited in the pipeline as of June 2023.2 Of RNA therapies in the pipeline, mRNA continues to be a preferred modality for research.

Leaders in the industry are evaluating how to approach manufacturing, processes, and expansion to stay ahead in the evolving market. You need to produce more, faster, while continuing to meet strict quality requirements. But how? Through automation.

McKinsey & Company states, “Pharmaceutical companies have the potential to bring medicines to market more than 500 days faster and reduce costs of development by 25% by implementing a comprehensive set of levers including, crucially, automation.”

Automation in pharmaceutical manufacturing refers to the use of technology and machinery to carry out various processes in the production of pharmaceutical products. It involves the integration of various automated systems and equipment to streamline and enhance efficiency, improve safety and productivity, while ensuring consistent quality of the product throughout the manufacturing process. Using automation brings many benefits and pharmaceutical companies can achieve the following:

• High Throughput: Automation enables faster and more efficient production, increasing output and productivity.
• Increased Overall Equipment Effectiveness (OEE): Automated systems minimize downtime, optimize maintenance schedules, and improve the overall efficiency of equipment utilization.
• Increased Flexibility: Automation allows for easy adaptability to changing production requirements, reducing the time and effort required for process modifications.
• Reduced Changeover Times: Automated systems streamline changeover procedures, minimizing downtime between product transitions.
• Quality, Consistency, and Improvements: Automation promotes precise and consistent manufacturing processes, improving product quality and reducing variability.
• Traceability and Serialization: Automated systems enable comprehensive tracking and tracing of pharmaceutical products, enhancing supply chain security and regulatory compliance.
• Digital Monitoring and Process Control: Automation facilitates real-time monitoring and control of critical parameters, ensuring process stability and reliability.
• Improved Sterility: Automation plays a vital role in maintaining aseptic and sterile conditions during pharmaceutical manufacturing, minimizing the risk of contamination.
• Optimized Production Cost: Automated processes reduce labor costs, minimize material waste, and optimize resource utilization, improving cost-efficiency.

Automation allows manufacturers to produce a product of consistent quality, in large quantities, with minimal downtime. These are the benefits of automation, also known as Pharma 4.0.4 So why hasn’t Pharma 4.0 been adopted by all pharmaceutical companies? Why are some companies quickly jumping in while others are slow to adopt changes or implement automated solutions?

The answer is complex. Firms, like people, assess risk in different ways. The most common concerns I have heard from clients are as follows:

• We don’t have an in-house expert and we’re afraid to make the wrong choice (i.e., invest money in areas that don’t yield the maximum benefit).
• We don’t believe we have the scale/size to benefit from automation.
• We don’t have the financial resources to invest the amount of money needed and the payback on the investment is too long.
• The automated solutions would be too complex or incompatible with our workflows.
• My facility is too complicated. No one firm can help me to automate all of the following areas:
  • Labs
  • Central utilities
  • Manufacturing lines
  • R&D systems
  • HVAC systems

Fear and lack of information is the common thread in these responses. The truth is none of these concerns are true roadblocks to leveraging automation in your environment. Whether you’re making 500,000 pills per hour, filling vials, or developing multiple biotech drug treatments, automation platforms can be leveraged to streamline these processes. The key is finding a design partner who will listen to your needs, understand your constraints, and deliver the solution that can take your operations to the next level.