Manufacturing in Pharmaceuticals: Benefits and Challenges

For dozens of years, pharmaceutical companies have manufactured their products in batches (called batch manufacturing). However, as the landscape becomes more competitive and demand increases, companies shift from batch manufacturing to continuous manufacturing. This blog highlights how Continuous manufacturing techniques are promising to increase workflow, enhance efficiency, reduce manufacturing costs, and quickly adapt to market demand. Consequently, continuous manufacturing in pharmaceuticals supports scalable growth. Let’s dive into the blog to learn more!

Why is the pharma industry shifting from batch to continuous manufacturing?

Several vital factors promote the shift from batch to continuous pharmaceutical manufacturing.

US FDA

For almost one decade, the United States Food and Drug Administration (FDA) has encouraged the shift from batch to continuous pharmaceutical manufacturing. The FDA has consistently developed and updated guidelines to shift the pharmaceutical industry from batch to continuous manufacturing. The FDA aims to simplify and streamline drug manufacturing and overcome the challenges in pharmaceutical supply chains using this tactic. 

Market demand

The continuously increasing market demand has rendered the batch manufacturing process inefficient. Companies that depend on batch manufacturing may need help to keep up with the constant shift in demand. Hence, they may have too much or too little of their stock, affecting their sales and, consequently, their market perception.

Cost pressure

The cost of drug development and manufacturing has increased pressure on pharmaceutical companies. Shifting from batch to continuous manufacturing is an effective way to minimise expenses while increasing manufacturing. Continuous manufacturing in pharmaceuticals decreases the downtime of equipment and product wastage, contributing to higher profits.

Environmental focus

The general public is becoming more aware of the environmental impact, which means industries, including pharmaceuticals, are focused on reducing their carbon footprint. Continuous manufacturing is an effective way to reach this goal because it results in lower energy consumption and waste generation than traditional batch processing methods.

Continuous manufacturing in pharmaceuticals is the next significant shift for many pharmaceutical companies, but it is not without its benefits.

Benefits of continuous manufacturing

Here are some of the most essential benefits of continuous manufacturing:

Reduced manufacturing costs

The most significant advantage of continuous manufacturing in pharmaceuticals is that it reduces manufacturing costs by reducing the amount of waste generated per batch of product. It optimises the use of raw materials and lowers energy consumption, allowing pharmaceutical companies to manufacture more units at the exact cost.

Improved manufacturing efficiency

Continuous manufacturing reduces the downtime of equipment. The streamlined processes can produce more units simultaneously, improving the manufacturing facility's overall efficiency. 

Higher market adaptability

Continuous manufacturing in pharmaceuticals offers flexibility – pharmaceutical companies can flexibly adapt to changes in market demand. The process can be easily scaled up or down according to the requirement. It reduces product loss due to overproduction, and companies never fall short of the market demand.

Enhanced process control

An integral part of continuous manufacturing in pharmaceuticals is real-time monitoring. This real-time monitoring allows workers to instantly identify if a process is going wrong and make the required changes. Consequently, the entire ‘batch’ is no longer spoiled, usually in batch manufacturing. This improved process control ensures few defective products are manufactured.

Some companies like Pfizer, Johnson & Johnson, Eli Lilly, and Novartis have already implemented continuous manufacturing in some facilities. However, several others have yet to shift from batch to continuous manufacturing. This is primarily because of the notable challenges of constant manufacturing.

Barriers and challenges of continuous manufacturing

Here are some of the challenges of continuous manufacturing for pharmaceutical companies:

Complex integration

The integration of continuous manufacturing in pharmaceuticals is complicated. It requires a significant up-front investment in technologies because most constant manufacturing processes are automated. Furthermore, the new continuous manufacturing processes must align with the original method. Consequently, the shift from batch to continuous manufacturing is complicated and time-consuming.

Training requirements

Because continuous manufacturing focuses on technological advancements, skilled staff must be hired. Furthermore, the staff needs to be upskilled as the company continues integrating new technologies to ensure its manufacturing processes remain continuous. Regular training programs need to be held to maintain or improve productivity.

Regulatory compliance challenges

The pharmaceutical industry is among the most regulated industries in the world. The shift from batch to continuous manufacturing is also subject to regulatory approvals. Companies must obtain process validation from regulatory bodies before making any facility changes. However, the shift to continuous manufacturing is not straightforward because these guidelines are still evolving.

Quality control requirements

As already emphasised, continuous manufacturing depends on real-time monitoring. It is necessary to ensure all raw materials are of the desired quality and all equipment is always calibrated. Both of these must be regularly monitored, and monitoring criteria must be updated with regulatory guidelines.

Conclusion

The adoption of continuous manufacturing in pharmaceuticals is encouraged by several factors, such as changing regulatory requirements and shifting market demand. However, this shift is perceived as a positive one. Primarily because the benefits of continuous manufacturing include reduced manufacturing costs and improved efficiency, despite these advantages, companies have to overcome several hurdles, the most important of which is regulatory compliance. Therefore, as the industry sits on the brink of a vast change, companies should take small steps to ensure they are not left behind. Companies should develop short- and long-term plans to change with the tide slowly.

FAQs

1. Does continuous manufacturing in pharmaceuticals come with an initial investment?

Continuous manufacturing relies on the automation of processes and real-time quality control using personnel. Companies have to invest in technologies for the former, and for the latter, companies have to hire skilled personnel.

2. Does the shift from batch to continuous manufacturing affect customers?

The shift from batch to continuous manufacturing ensures the consistent production of medication, which means customers will receive a higher-quality product.

3. What are some other benefits of continuous manufacturing?

Other benefits of continuous manufacturing include production flexibility, reduced energy consumption, reduced wastage, and faster production times.