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Continuous Manufacturing in pharma: benefits and challenges.

Continuous manufacturing is a real-life example of how predictive analytics techniques can revolutionize the way a solid-dose drug is produced. It offers the pharmaceutical industry the best of both worlds: higher quality products, made more cost-effectively. But, a new approach brings new challenges. Here, I’ll try to briefly introduce benefits and challenges from a software producer perspective.

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 (CM).

Benefits of Continuous Manufacturing

In CM 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, CM 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 CM enables real-time quality checking — eliminating batch release delays.

Because CM 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, CM 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 CM, 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 "predictive plant" as defined by Biophorum. The installation, operation and maintenance of CM systems can require specialists in everything from systems engineering to data analytics. That said, implementation doesn’t have to be complex.

COPA DATA’s zenon software platform can help manufacturers 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, including an ISA88 batch control engine and Process Orchestration (MTP POL).

As well as integrating equipment and services, zenon can easily exchange real-time or local 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 CM system, helping businesses to monitor and optimise production processes.

CM 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.

Like any innovation, Continuous Manufacturing brings with it challenges. Software plays a key role in this context. The improvement of solutions is also achieved through the adoption of open, flexible and modular software platforms.