Breaking Ground

Breaking Ground

Innovations in pharmaceutical manufacturing advances delivery of groundbreaking therapies.

By Mauricio Futran

The concept of continuous manufacturing (CM) is not a new one; after all, everything from cars to snack foods have utilized the process, automating their production lines from start to finish on a single line while tracking status throughout, for many years. However, while other industries have enhanced their processes to apply newer technological capabilities associated with continuous manufacturing, the pharmaceutical industry’s traditional “batch” manufacturing – where pills or products are created in a step-by-step process that can take weeks and span multiple production facilities – remains the norm. This has shifted rapidly in recent years, with both the agencies and the pharmaceutical companies pursuing a number of advanced technologies to enhance efficiency, reliability, agility and reduce cost.

As an industry professional, it is my belief that as the pharmaceutical and biotechnology industry and market evolve, so should our manufacturing sites and processes in order to accelerate our ability as manufacturers to meet customer needs. The need for this shift in approach was further underscored in the past two years through recommendations from health care authorities.

In 2015, Janet Woodcock, director of the U.S. Food & Drug Administration (FDA) Center for Drug Evaluation & Research (CDER), urged companies to get on board with this new process when she spoke publicly in front of Congress embracing the values of the pharmaceutical industry implementing continuous manufacturing technology into their production lines. This new approach enables much faster production and equally reliable products – an appealing set of benefits when it comes to the delivery of safe medicines to people around the world in need – through an uninterrupted process. It can reduce testing-to-release time of pharmaceutical products from 30 days to a target of 10 days or less.

By incorporating state-of-the-art continuous production and control technology, companies now have the ability to produce a high-quality product while meeting the FDA’s challenge to accelerate the delivery of innovative therapies for patients.

Although it is not easy for pharmaceutical manufacturers to transition from batch to continuous manufacturing, the rewards of implementation are widespread: incorporation of process analytical technology, a reduction in waste, footprint, environmental impact and active pharmaceutical ingredient (API) consumption and increased safety due to no manual handling of raw materials. 

I believe Lawrence Yu, the FDA’s deputy director for the Office of Pharmaceutical Quality, summed it up best in a recent blog post saying that, “Of course, speed alone would not matter if continuous manufacturing compromised quality. But by eliminating breaks between steps and reducing opportunities for human errors during the stops and starts in the batch process, continuous manufacturing is more reliable – and safer. That’s a powerful combination.”

Progress in pharmaceutical manufacturing comes at an opportune time as we are entering an era of precision medicine. Certain therapies must be made with unique dosage features, and continuous manufacturing can ensure the utmost quality while delivering these life-changing treatments more quickly to patients in need.

Looking to the future, I believe that we will see increased investment in continuous manufacturing in pharmaceutical product development on the R&D side and potential application in biologics manufacturing as well. These activities could lead to reduced scale-up time and, eventually, shorter time-to-market, which would be a positive outcome for both pharmaceutical manufacturers and patients.

Mauricio Futran is the vice president of advanced technology for Janssen Supply Chain. Janssen was the first company in the pharmaceutical industry to convert from batch to continuous manufacturing.

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