The FDA believes that continuous manufacturing is not only more reliable but also safer, producing what they deem ‘a powerful combination.’

It is no secret that the pharmaceutical industry has been hesitant to embrace the advent of continuous manufacturing — and, to be fair, with good reason. Over the past 50 years or so, the processes and production techniques employed by the vast majority of manufacturers remain unchanged.

In part, that’s because batch technology works; it’s the same tech that’s been doing the job — and doing it well — for decades. But continuous manufacturing has advantages that manufacturers can’t ignore, including an overall increase in efficiency, faster production and a stronger quality of product, to name a few.

Batch tech (with its now well-known pros and cons) won’t be replaced anytime soon, but it would be bad business to deny the palpable shift toward continuous manufacturing taking place industry wide. Even harder to deny is that continuous manufacturing is a glimpse into the future of pharmaceutical production.

Collaboration in Real-Time

This time last year Patheon’s Eric Jayjock, PhD, Director of Continuous Manufacturing, said he wouldn’t be surprised to find (in 10 years’ time) that most new products in brand-name pharma would be produced via continuous manufacturing.

“Three years ago there were a minority of people really excited about continuous manufacturing,” said Jayjock. “The momentum shift over the last three years has been very significant.”

A large part of this “momentum shift” comes following the increased support of the U.S. Food and Drug Administration (FDA). The FDA believes that continuous manufacturing is not only more reliable but also safer, producing what they deem “a powerful combination.”

That’s one reason why the FDA has already approved continuously manufactured drugs, like Vertex’s Orkambi.

“There’s the added benefit that more efficient production of quality products can drive down manufacturing costs, possibly resulting in lower drug prices for consumers,” writes Lawrence Yu, the FDA’s Deputy Director, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research. “Continuous manufacturing also allows manufacturers to respond much quicker to changes in demand, potentially contributing to prevention of drug shortages.”

With more pharmaceutical manufacturers integrating continuous manufacturing into production, Yu says he hopes other drug manufacturers will consider similar initiatives.

“Progress comes at an opportune time,” Yu writes. “The medications we use are changing. We are entering an era of precision medicine, when drugs must be made with unique features and provided more quickly to patients in need. [The] FDA will continue our efforts to encourage the advancement of continuous manufacturing as one of a variety of ways to enhance the quality of the medications used by the American public.”

Regulatory hurdles aside, another sure sign of continuous manufacturing’s coming force is in research-based partnerships.

Follow the (Industry) Leader

One such example is the collaboration between Thermo Fisher Scientific and the Rutgers School of Engineering Research Center. Announced at the end of 2016, this new partnership will accelerate the university’s ongoing research on continuous manufacturing techniques for pharmaceutical discovery.

“Continuous manufacturing represents the future of advanced pharmaceutical manufacturing and will produce significant improvements in efficiency, safety, cost and speed to market,” said Fernando J. Muzzio, a distinguished professor at Rutgers and the director of the National Science Foundation/Engineering Research Center on Structured Organic Particulate Systems. “Our ability to partner with leading companies continues to position the center to best serve the scientific community, the pharmaceutical industry and the regulatory agencies.”

These partnerships also underline just how complicated and expensive continuous manufacturing adoption really is; hence, why it necessitates research and development at such high levels.

In a recent interview with Pharmaceutical Processing, Bayan Takizawa, MD, MBA, Co-Founder & Chief Business Officer of CONTINUUS Pharmaceuticals—a spin-out of the Novartis-MIT Center for Continuous Manufacturing — spoke about some of the complexities of implementing continuous manufacturing.

“One major challenge is the existing batch infrastructure that many companies already have in place,” Takizawa said. “When this occurs, companies are reluctant to invest in novel machinery. Another challenge is the pervasive mindset of the industry that pharmaceuticals should be produced via this outdated methodology simply because that is the way it has always been done.”

And, while easier production transitions is a recognizable goal for research teams befitting large-scale collaborations, the grander design is an industry wide push to invest in this new, innovative tech.

“As the FDA encourages drug manufacturers to consider adoption of new continuous manufacturing technology, we see collaborations like this playing a vital role in the pharmaceutical industry’s evolution,” said Phillip van de Werken, Vice President/General Manager, Molecular Spectroscopy for Thermo Fisher Scientific. “[The Rutgers-Thermo Fisher Scientific] collaboration will help in the development of improved drug delivery systems and manufacturing processes.”

Takizawa agrees and predicts that more companies will invest in continuous manufacturing technologies.

“Currently, most companies that engage in continuous manufacturing do so in a piece-meal or fragmented manner,” Takizawa said. “They are already seeing benefits from this transition; however, there is much more to be gained once an end-to-end strategy is implemented . . . and investments will provide a significant competitive advantage to early adopters. As the pharmaceutical manufacturing industry evolves, higher-quality drugs will be produced faster and more cost effectively, ultimately benefiting patients around the world.”

So, in summary, it’s understandable to harbor reservations about continuous manufacturing. Change at this scale is expensive and time-consuming. But manufacturers know the value of innovation, and they know they won’t be able to remain competitive without investing in strategies to ensure long-term operational efficiency and flexibility.

This article originally appeared in the March 22 edition of the 2017 INTERPHEX Show Daily.

Follow us on Twitter and Facebook for updates on the latest pharmaceutical and biopharmaceutical manufacturing news!