Why Continuous Pharmaceutical Manufacturing Is Causing a Stir in the Pharma Industry
Pharmaceutical manufacturing is undergoing a significant change. Batch manufacturing, which has long been the preferred method of making pharmaceutical drugs, is slowly giving way to continuous manufacturing (CM). While CM has been used for hundreds of years in other industries, its adoption by the pharmaceutical industry is new and causing a lot of excitement.
Below we’ll take a look at what the differences between continuous and batch manufacturing are, why pharmaceutical companies are switching to CM, and what the future of CM in the pharmaceutical industry looks like.
Batch Has Long Been the Preferred Production Method for Pharmaceutical Manufacturing
Currently, the pharmaceutical industry relies heavily on batch manufacturing. With this manufacturing technique, batches of pharmaceutical drugs are made in specified quantities within defined time frames. The manufacturing process is broken down into stages, with different components of the drug made during each stage.
Continuous manufacturing, on the other hand, is when the manufacturing process is done in a continuous, non-stop flow. Instead of a step-by-step process, pharmaceutical products are produced constantly with minimal division between one step and the next. Production does not stop and in true CM facilities, production takes place 24 hours a day, 7 days a week.
Continuous Manufacturing Could Help Improve the Safety and Quality of Products
Batch manufacturing is a well-established method, but it has limitations that CM helps address. For one, in batch production, a new batch cannot be started until the last batch is finished, which can slow down the entire manufacturing process. The ability to produce drugs continuously with CM could help alleviate drug shortages that the healthcare industry is currently contending with.
CM also has significant safety advantages. For example, there is less manual handling of the pharmaceutical ingredients by employees, so the risk of contamination is reduced. This benefit is significant since many pharmaceutical recalls are the result of contamination caused by human handling during manufacturing. Furthermore, with CM quality control is built into the manufacturing process through online monitoring and real-time testing, allowing manufacturers to adjust the production process in real-time and catch quality issues almost immediately.
Other benefits include CM equipment taking up less space than batch equipment and the process resulting in greater cost savings over time for manufacturers. That could potentially result in lower drug prices for consumers, thus making medications more accessible.
Continuous Manufacturing is Best for Certain Pharmaceutical Manufacturing Techniques
CM has many advantages, but it is not suitable for every company or product. For example, CM is ideal for some of the manufacturing techniques you’ll learn about in your pharmaceutical manufacturing program but not others. Specifically, dry granulation and direct compression can be easily adapted to continuous production.
Additionally, pharmaceutical companies have to pay attention to the percentage of active ingredients contained in their products when deciding whether to switch to CM. If the percentage of active ingredients in the product needs to be very low—which is often the case for drugs that are highly potent—then CM may not be suitable. Keeping the percentage of active ingredients within a safe range in such cases can be challenging using CM. So, batch manufacturing will continue to have a role to play in the pharmaceutical industry. However, during your pharmaceutical manufacturing career, you are likely to encounter more CM processes being utilized alongside batch manufacturing.
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