Continuous manufacturing offers the pharmaceutical industry the best of both worlds: higher quality products, made more cost-effectively. But, a new approach brings new challenges. Here, Giuseppe Menin, Pharmaceutical Industry Manager at industrial software provider, COPA-DATA, introduces the benefits and challenges of continuous manufacturing and explains how pharmaceutical businesses can apply it successfully.
Traditional batch manufacturing is still the norm in the pharmaceutical industry. After each manufacturing stage, production stops for samples of the product to be quality tested, before the process moves on to the next step or piece of equipment.
Drawbacks to this method include taking longer to create product, a larger footprint on the factory floor, and only a small portion of each batch being thoroughly quality checked. One solution to these problems is continuous manufacturing.
Benefits of continuous manufacturing
In continuous manufacturing products are made from start to finish with no hold times or breaks in the production line. Designed for increased agility and flexibility, this production method offers greater control over manufacturing processes, resulting in numerous benefits.
Firstly, continuous manufacturing offers consistent quality whether production volumes are high or low. By utilising process analytical technology (PAT), manufacturers can reduce human error and improve product quality. Not only that, but continuous manufacturing enables real-time quality checking — eliminating batch release delays.
Because continuous manufacturing production lines adapt easily, manufacturers become more agile, able to accommodate growing demand or market changes without a complex, costly and time-consuming scale up. Ultimately, continuous manufacturing reduces costs — saving time, avoiding quality controls in laboratory, reducing waste and lowering the amount of space required — while also improving quality of the final product.
Despite the many advantages of continuous manufacturing, only a handful of drugs are currently produced this way — and all of those are produced by big pharma organisations like Janssen, Eli Lilly and Vertex. Unfortunately, there are challenges to deploying continuous manufacturing that pose a barrier. Chiefly, these challenges include high investment cost, system complexity and lack of qualified personnel.
Implementing continuous manufacturing
To address the problem of unqualified personnel, businesses should prepare for the future by hiring and training staff to work in a connected plant. The installation, operation and maintenance of continuous manufacturing systems can require specialists in everything from systems engineering to data analytics. That said, implementation doesn’t have to be complex.
Manufacturers can turn to software, like COPA DATA’s zenon, to smoothly integrate different subsystems like PAT, MVDA, control systems and devices. This way, software can simplify the life of operators by creating a unified and comprehensive process control workstation.
As well as integrating equipment and services, zenon can easily exchange real-time or historical data with other information technology (IT) systems and enables the efficient creation and distribution of reports. This is combined with the ability to create customized views for critical process parameters (CPPs), trends and deviations meaning that operators can catch problems before they escalate. As a result, software is an important part of a continuous manufacturing system, helping businesses to monitor and optimise production processes.
Continuous manufacturing promises many benefits for the pharmaceutical industry, including greater efficiency, quality and consistency. Yet take-up in the sector is slow, with barriers including cost, complexity and the availability of qualified staff.
To prepare for the transition to continuous manufacturing, companies should invest in an open, modular and flexible software platform that can scale and adapt with the business, able to reduce complexity, ensure quality and compliance both now and in the future.