Difference between Batch vs Continuous Pharma Manufacturing

Batch vs. continuous manufacturing has long been one of the main topics of debate among the pharma manufacturers. While batch manufacturing has been the industry standard for pharmaceutical manufacturing for well over five decades now, continuous manufacturing has emerged as a strong alternative in recent years. Let’s dive deeper to understand each type of processing, their advantages and disadvantages, and the differences between them.

Overview

If we talk about the pharmaceutical manufacturing industry, batch manufacturing — also referred to as batch processing or batch production — has been the trusted method for production of drugs. Majority of the industry operators have for long relied on batch manufacturing process to supply quality drugs to the public.

However, another approach to manufacturing of drugs has gained popularity in recent years. Continuous manufacturing, which was being widely used till recent past in other industries, is now starting to be adopted as a production process by the pharmaceutical industry.

There are a number of reasons behind its rapid rise as a prospective alternative to batch manufacturing. The substantial savings that it offers in terms of time and resource is one such reason; and improvements to process efficiencies, and product quality is another.?

So, as a pharma manufacturer, which method should you choose? Should you stick to the tried and tested method of batch manufacturing, or should you modernize your manufacturing by moving to continuous production? In this blog, we’ll see which approach fits your business needs the most. Let’s first start with understanding batch manufacturing.

What is batch manufacturing?

Using the batch manufacturing approach, drugs are produced following a process that involves multiple steps. The constituents of a drug move through the production line in batches and at the end of each step, there’s a gap which holds the production before the process moves to the next step.

The hold times may vary depending on the next stage of the process. It is also to be noted that in batch manufacturing, subsequent batches can only be processed after the current batch has finished. This means that once one batch is completed, the next begins, so on and so forth.

Advantages & disadvantages of batch manufacturing

Lower initial setup cost is possibly the most definite advantage?of batch manufacturing. Another benefit it offers is that it lets users set up each process uniquely, to adapt to the materials they’re working with.

Using the batch manufacturing approach, pharmaceutical manufacturing companies can produce a drug in a set quantity, before adjusting its manufacturing priorities according to the changing demands of the market. In fact, to produce certain drugs, it is the only viable method.

Particularly in an industry such as pharma manufacturing, where regulatory watchdogs lay emphasis on the quality and standards for processing, batch manufacturing comes with a lot of benefits. It enhances the quality and capabilities of the product by the use of more advanced machines, without requiring constant adjustments to them.

Besides these benefits to batch manufacturing, there are certain downsides?too. The amount of time it takes to manufacture a product using the batch manufacturing approach is a huge downside to it. Then there are the hold times that increase the risk of material degradation.

Scaling production too could be challenging while using the batch production approach, as it usually requires scaling up your machines/equipment, which comes at a cost of time, money, energy and other resources, and additional space.

Also since batch manufacturing goes at a much slower pace, the overall cost of processing goes up. If the batch process isn’t monitored minutely, the quality discrepancy between batches may go up, and may even lead to lost production.

What is continuous manufacturing?

We discussed briefly above that other manufacturing industries have been using the continuous manufacturing technique for long, and it is only recently that the pharma industry has moved to it.

Using the continuous processing approach, a pharmaceutical product gets produced nonstop in one continuous manufacturing process. From start to finish, the entire process takes place in one facility, without hold times.

This approach is driven by the smart sensor technology that’s available on the manufacturing lines. It’s happening all the time, and standardizes laboratory testing as well as quality control.

Advantages & disadvantages of continuous manufacturing

Some of the upsides?of the continuous manufacturing approach include reduced manufacturing costs over the long term, shorter production times that include manufacturing time being brought down from weeks to days, increased productivity by completing more units in less time, and improved quality by making it easier to spot and fix errors.

Also, in continuous manufacturing approach, monitoring becomes more efficient as it typically uses automated monitoring techniques and predictive maintenance.

Additionally, continuous manufacturing reduces human errors, is more agile, and makes scaling production much easier. Scaling up using continuous approach, for instance, simply means running the continuous manufacturing process for a longer period.

While continuous manufacturing approach is ideal for many industries, there are a few downsides?to it as well. Some industries like pharmaceutical, food manufacturing, and others, are better off with batch manufacturing approach, as the continuous approach increases the risk of contamination of materials.

Then there are other factors too, such as the high start-up costs, the need for developing the quality-control metrics, and overall lack of experience that prevent manufacturing organizations from switching to the continuous approach. Industry operators also fear regarding approval delays for drugs manufactured using continuous manufacturing approach.

Also, in continuous manufacturing, it can get difficult to trace back the errors once they occur, if each batch isn’t checked properly. This is often why we get to see major product recalls. Lastly, obtaining an acceptable ROI for machinery costs can be difficult, since the machinery for continuous manufacturing is way more expensive than the one used in batch production.

Difference between batch and continuous manufacturing

It is clear both the processes have their own pros and cons. However, in the case of continuous manufacturing, its advantages such as the decreased cost, improved quality, and increased productivity far outweigh the advantages of batch manufacturing approach.

Weigh your choice

Recognizing this, pharmaceutical manufacturing organizations like Eli Lilly, Vertex, and Jannsen have already taken to continuous manufacturing, making substantial investment towards upgrading their facilities to support the continuous production method.

However, since it is still an emerging field, there are still significant hurdles that need to be overcome.?It is important for pharmaceutical organizations to weigh the choice in accordance with the needs of their business, and select the approach that fits their products the best.

If you have got any further query on the subject of batch vs. continuous manufacturing, or need help with making the choice that’s best for your business, connect?with our?ERP experts, today.