Continuous Manufacturing vs Batch Manufacturing in the Pharmaceutical Industry

Batch manufacturing is the tried, tested, and trusted approach for manufacturing pharmaceutical products. There is an increasing push, however, for the industry to switch to continuous manufacturing.

A key driver of this push is the FDA – the Food and Drug Administration in the US. The FDA believes continuous manufacturing improves product quality, reduces medicine shortages, and enhances efficiencies, among other things.

So, should you modernise by moving to continuous manufacturing processes, or should you stay with batch manufacturing?

Batch Manufacturing Explained

Batch manufacturing involves manufacturing pharmaceutical products in multiple steps. At the end of each step, production stops before the process moves to the next step. Hold times like this can vary depending on the next stage of the process.

For example, in some situations, materials are shipped to a different location between steps. For some pharmaceutical products, this results in production times being measured in weeks or months.

Advantages of Batch Manufacturing

The main benefit of batch manufacturing is the fact it is well established, and it works. In addition, pharmaceutical companies have approval from regulators for their products based on them being produced using batch manufacturing techniques.

You probably also have an established and effective supply chain linked to your batch manufacturing process.

For all these reasons, changing from batch manufacturing to continuous manufacturing for existing processes is a significant undertaking. This is before you even take into account the investment required in new equipment, the risks of introducing a new process, and the time it will take to develop the new process, train your team, etc.

Finally, there is also the fact that batch manufacturing is the only viable method to produce certain drugs, although this may change as new technologies are developed.

Disadvantages of Batch Manufacturing

While there are benefits to batch manufacturing, there are downsides too. The length of time it takes to produce a product using batch manufacturing is one of those downsides. Hold times also increase the risk of material degradation, while scaling production can be a challenge.

The latter particularly applies to scaling up production. To scale up production in a batch manufacturing process, you typically need to scale up your equipment. This requires time, money, and additional space.

Continuous Manufacturing Explained

The pharmaceutical industry stands out from many other manufacturing industries that have been using the continuous manufacturing technique for decades.

Continuous manufacturing involves a pharmaceutical product being produced nonstop in one continuous manufacturing process. The entire process takes place in one facility, start to finish, without hold times.

Advantages of Continuous Manufacturing

The benefits of continuous manufacturing include:

  • Reduced manufacturing costs, particularly over the long term
  • Shorter production times – reducing manufacturing times from weeks to days is not unusual
  • Reduces the risk of human error
  • Improves quality
  • Monitoring is more efficient as continuous manufacturing processes typically use automated monitoring techniques and predictive maintenance

In addition, continuous manufacturing is a more agile technique, making scaling production much easier. Scaling up, for example, simply means running the continuous manufacturing process for longer.

In other words, matching supply to demand is much easier with continuous manufacturing than it is with batch manufacturing

Continuous manufacturing also makes track and trace more flexible, i.e. instead of a batch being defined by the equipment used in its manufacture, you can instead define a drug’s batch quantity based on things like a period of time or the quantity manufactured. This makes it possible to have smaller batch sizes which means less waste when defects are detected in a batch.

Is Continuous Manufacturing the Future for the Pharmaceutical Industry?

While the move towards the use of continuous manufacturing techniques has been slow, more and more facilities are choosing continuous manufacturing processes when introducing a new product.

In addition, regulators continue to allay fears in the industry regarding approval delays for drugs produced using continuous manufacturing techniques.

Plus, the benefits of continuous manufacturing are too hard to ignore.

At least for new products and new facilities, continuous manufacturing is increasingly the future for the pharmaceutical industry.

Shane McLaughlin

Shane is SL Controls’ Business Development Manager and has extensive experience and a demonstrated history of working in the regulated automation industry. His areas of expertise include Verification and Validation (V&V), Process Control/Monitoring, Medical Devices, Pharmaceutical, Bio Pharma, Failure Mode and Effects Analysis, and systems engineering. He also has experience leading technical teams and delivering to demanding schedules.

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