How IoT Will Transform Pharmaceutical Manufacturing

The pharmaceutical industry heavily involves research and development, manufacturing, testing, and quality control. Unfortunately, although these operations sound like they should be using cutting-edge technology, they’re simply not. Many pharmaceutical companies are using manufacturing processes that are decades old and out of date.

These processes are a perfect fit for the Internet of Things (IoT), which can help with untangling complex supply chains and keeping track of chemical processes without a loss in efficiency or quality of drugs. In comparable industries, like chemical manufacturing, these operations are being phased out in favor of IoT applications that simplify and streamline many of the tedious tasks involved in each process.

The Numerous Challenges of Pharmaceutical Manufacturing

Manufacturing relies on time and continuity for maximum efficiency. But in the pharmaceutical industry, things aren’t so cut and dry. Drugs are usually developed in large batches, involving mixing compounds in large vats. Upon mixing, the product needs to sit for a while to measure the quality of intermediate products. This can cause delays across the entire company.

After the new chemical compound is measured for its quality, it moves to another step, which can sometimes involve another facility. Because of the timeline and amount of floor space required for each drug’s development, machinery isn’t used continuously. And information and data about the quality, status, and condition of the chemical compound are often stored and distributed through a variety of systems. Many companies still record and store data on paper.

For manufacturing to be optimized for maximum output and efficiency, machinery needs to be used continuously. This means planning ahead, even by years, to experience the biggest cost savings. This is how it’s done across a variety of industries, and pharmaceutical companies need to catch up.

IoT technology is a perfect match for these business and processes problems, and it offers more flexibility, transparency, and return on investment than anything else on the market. But the road to modernizing the pharmaceutical industry’s manufacturing processes is a very rocky one.

Navigating Necessary Regulations

The pharmaceutical industry is heavily regulated due to the life-or-death consequences of its products. When regulations need to be considered, lengthy delays usually follow. For example, to submit a drug for approval by the U.S. Food and Drug Administration (FDA), you’re required to submit detailed paperwork of every single part about the drug’s manufacturing process.

This includes the active compound, the manufacturing process, and even the layout of the chemical plant. If there any changes to be made in the process, it first requires direct approval from the regulatory committee along with some paperwork. Because of these regulatory hurdles, pharmaceutical companies require much more planning of their experiments and drug development.

To help cut down the time it takes to navigate regulations and receive approval, the FDA started the Emerging Technology Team (ETT). The ETT’s goal is to encourage new manufacturing methods, like continuous manufacturing. This enables pharmaceutical companies to submit their ideas before submitting the regulatory paperwork

IoT and Compliance

The FDA isn’t the first regulatory body to improve drug development. In fact, more than 100 such agencies exist across the world, and they all require their own paperwork, which can be a major timesink for global pharmaceutical companies. The ETT has made positive change and growth for the pharmaceutical industry, however.

Boston-based Vertex Pharmaceuticals has been using continuous manufacturing for their cystic fibrosis drug, Orkambi, since 2015. In 2016, Janssen Pharmaceuticals switched over to continuous manufacturing for their HIV drug, Prezista. Both companies worked closely with the FDA to ensure approval of the modern manufacturing process before they submitted their drug approval paperwork. According to Johnson & Johnson, separating testing and sampling using IoT sensors afforded the company a significant improvement over their previous methods.

By combining medical applications with IoT, pharmaceutical companies can remotely monitor and document every step, variation, and concentration during each part of the manufacturing process. The best part is that they can do everything in real-time, enabling plant operators, researchers, and chemists to know what’s happening during the entire process. Companies can also track drugs for recalls if a specific chemical poses a problem for consumers.

Pharmaceutical supply chains are complex and finicky. Often, a reliable chemical supplier can lose their inventory overnight, causing global problems in drug manufacturing. With IoT, pharmaceutical companies can monitor and document the activity of their contract manufacturing organizations, which are hired to complete much of the manufacturing of the drug.

Additionally, pharmaceutical companies often use different suppliers and vendors to manufacture the active ingredient, formulate new drugs, and package the medication. Regulatory bodies want to monitor, track, and report on each company’s vendors, and IoT can deliver everything in a nice wrapped-up package with a bow.

The Future of Pharma

We need pharmaceutical companies to survive, but we can lower drug prices and the cost to research and develop new medications by introducing IoT technology into the current outdated manufacturing processes. Above all, pharmaceutical companies need to maintain a strict level of high quality in their drugs. Currently, if a drug has possible quality issues, it’s treated as spoiled. But with IoT, tracking down chemical sources will be easier so that action can be taken quickly.

As pharmaceutical equipment tends to be expensive and labor-intensive to produce, continuous manufacturing is even more necessary to improve drug development. And although continuous manufacturing saves a lot of time and resources, it can cause major disruptions in manufacturing from equipment failure. As a result, IoT sensor data, real-time asset management, and preventative maintenance will become bigger priorities.