Continuous Processing for Personalized Medicine: Enabling On-Demand Drug Manufacturing

Personalized medicine could revolutionize health care. Therapies designed to treat patients based on their genetic conditions, disease subtypes, and biomarkers could boost success rates and improve overall value for patients. Unfortunately, traditional batch manufacturing methods lack opportunities to meet demands and support efficient personalized medicine production.

Thankfully, another solution is on the horizon — continuous manufacturing. Personalized medicine could make health care more precise, patient-centered, and proactive. With the help of continuous processing, health care teams can ensure the right person receives necessary treatments at the correct time. This strategy could transform the health care industry by solving traditional batch manufacturing challenges and enabling on-demand drug manufacturing.

Understanding Pharmaceutical Continuous Manufacturing

While batch processing has a definitive start and end, continuous processing runs nonstop. Raw materials enter mixers at one end of the process, and final products emerge at the other. Manufacturers needing high-volume production or requiring immense quality control and consistency use this method to increase efficiency and improve product safety.

Batch manufacturing produces identical goods simultaneously in batches. As products move throughout the production process, each batch must complete one stage before the next batch can begin. Raw materials only move from stage to stage after all materials in the batch have completed the current stage.

For example, consider a pharmaceutical company needing 100,000 tablets of a pain relief medication. One stage of batch processing could consist of weighing and mixing ingredients, while another stage could involve compressing granules into a tablet press. The final stage would consist of packaging. The company would need to complete several batches to reach the 100,000 tablet goal.

In continuous manufacturing, production occurs without interruption. Using the same example, a pharmaceutical company could rely on continuous processing to feed raw materials at a controlled rate into a mixer. Materials would move through processes like granulation, drying, compression, and packaging seamlessly, producing finished products without stops between stages.

Many businesses opt for continuous processing to increase efficiency and productivity. Continuous manufacturing can enhance process control and improve product quality while reducing operational costs and creating a smaller footprint. To deliver these benefits, continuous processing relies on several key principles:

• Continuous flow of materials: Rather than processing a fixed amount of raw materials, products move through each stage in an uninterrupted stream. This steady flow reduces downtime between steps and enables faster production.
• Real-time monitoring and control: Sensors and analytical tools monitor the production process in real time. Instruments measure critical attributes such as content uniformity, weight, and moisture levels to identify deviations or quality issues immediately.
• Automated processes: Continuous manufacturing minimizes human responsibility in the production process. Advanced automation and software systems control the entire manufacturing process, ensuring consistency, reducing human error, and ensuring rapid response to process changes.

The Role of Continuous Manufacturing in Personalized Medicine

Continuous manufacturing makes it possible to quickly, safely, and efficiently produce personalized medicines. This production method allows you to quickly adjust systems to produce various drug formulations, dosages, and combinations. This means manufacturers can reprogram systems on the fly.  Sometime minor changes can be realized without needing to halt the entire process or simplify cleaning procedures between batches. Additionally, this method allows manufacturers to produce medicines as needed rather than in large, fixed batches.

For example, teams could tailor chemotherapy capsules and tablets, customizing drug type and dosage to a patient’s genetic profile. Antidepressants could be adjusted to optimize efficacy and minimize side effects based on a patient’s needs. For patients needing nonstandard strengths or special formulations, such as children or elderly patients, continuous manufacturing can simplify the production process to ensure precise doses. This method could even aid in treating rare diseases by allowing teams to produce small quantities of small-molecule drugs and enzyme therapies while reducing waste.

This process could also create new opportunities for point-of-care manufacturing and decentralized drug production. With the right equipment and systems, teams could complete personalized medicine manufacturing directly at the location where patients receive care, including clinics, hospitals, or pharmacies. In emergencies, point-of-care manufacturing could enable faster responses to outbreaks or critical needs.

Key Technologies Driving Continuous Processing for Personalized Medicine

Continuous processing enables teams to create recipes that are not possible using batch processing methods. This method relies on advanced technologies to simplify scaling, improve process control, and improve utilization. The tech behind the transformation includes:

• Microreactors: Microreactors are highly controlled reaction vessels that enable precise control over chemical reactions. These instruments make it safe to synthesize potent or complex drugs while ensuring product quality and improving reproducibility.
• 3D printing: These machines allow teams to create customized drug formulations and delivery devices. 3D printers can leverage materials like liquids, gels, and powders to create tablets and pills with customized dosages and profiles.
• Process Analytical Technology (PAT): This suite of real-time monitoring tools consists of sensors, software, and analyzers that track quality attributes. PAT can ensure every dose meets stringent quality standards, even as formulations change.
• Automation and advanced control systems: Integrated hardware and software optimize the manufacturing processes while minimizing the need for human intervention. These technologies ensure consistent product quality and efficient operation by adjusting ingredient feeds, enabling remote monitoring, and coordinating technologies for seamless production.

Benefits of Continuous Manufacturing for Medicine

Continuous manufacturing offers a range of benefits, especially compared to traditional batch processing. Benefits of this method include:

• Improved drug quality and consistency: Real-time monitoring and control systems ensure every medication meets strict quality standards while meeting patient needs. This method reduces variability between batches, minimizing the risk of recalls or defects.
• Reduced manufacturing costs: Continuous processes use energy and materials more efficiently than traditional methods, empowering teams to reduce waste, minimize downtime, and lower utility usage. This method requires less human labor, less inventory, and lower raw material quantities, which can translate to significant cost savings and optimization.
• Faster time to market for new therapies: With real-time quality assurance and rapid scale-up, manufacturing teams can shorten the time to market for new therapies. On-demand manufacturing can also allow teams to respond faster to emerging health threats and, potentially, shorten clinical timelines.
• Enhanced process control and traceability: Advanced technologies and monitoring systems enhance process control and traceability. Manufacturers can immediately detect and correct process deviations, ensure consistent product quality, and maintain detailed records for every produced unit. If an issue arises, this information and technology will make it easier to identify the root cause.
• More sustainable manufacturing: Continuous processing allows manufacturers to create a smaller footprint by reducing waste and enhancing energy efficiency. On-demand production eliminates overproduction challenges and product waste. Additionally, immediate process deviation detection allows manufacturers to further minimize wasted materials.

Challenges of Implementing Continuous Pharmaceutical Manufacturing

Like many new processes and technologies, continuous manufacturing offers exciting opportunities but also presents unique challenges, including:

• Regulatory hurdles and the need for clear guidelines: Many current regulatory frameworks center around traditional batch processing, which means the new concepts of continuous manufacturing may not fit into existing regulations. Uncertainty about regulatory expectations could slow process adoption.
• Technology adoption and integration: This method requires new equipment and technologies. Integrating these technologies with existing IT systems and infrastructure could pose complex and costly challenges. Teams may experience disruptions during transition or lack the resources for the high upfront investment.
• Process development and optimization: Developing robust processes for complex pharmaceuticals is technically demanding. Each drug may require unique parameters, validation approaches, or control strategies. This challenge could result in longer development timelines or demand extensive process modeling.
• Workforce training and education: Although advanced technologies and systems power continuous processing, a skilled workforce is still necessary. Many pharmaceutical professionals may lack the technical skills to understand the data analytics and process controls that drive this production method. Large skills gaps could slow process implementation or increase the risk of errors.

Implementing continuous processing requires overcoming regulatory uncertainty, investing in technology, developing robust processes, and upskilling the workforce. The next few years could see regulation innovation, technology partnerships, workforce development initiatives, and data-driven collaboration to overcome these challenges and unlock the full potential of continuous manufacturing in modern medicine.