Afnan's Letter from Japan: Japanese Pharma's Embracing PAT, QbD and Opex Tools

As its auto industry has done, Japan pharma may demonstrate that a cheaper manufacturing base is not necessarily the solution to our problems.

By Ali Afnan, Principal, Step Change Pharma, Inc.

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In July, with Japan still wounded from the Tohoku area earthquake and tsunami, over 400 drug industry professionals and thought leaders came together in Osaka for the 9th annual New Pharmaceutical Technology and Engineering (NPTE) conference—sponsored and hosted by the Powerex Corporation.

We were gracefully accepted and welcomed, while the intellectual banquet was colorful and rich: product development, formulation, innovative and continuous manufacturing, biotech, nanotechnology, high containment, and regulation.

Bittersweet memories came back to me as I met with friends and former colleagues from Japan, the U.K., and particularly from Germany. I still take pride in having led the effort, while working for AstraZeneca, in designing, installing and commissioning the very first PAT system a decade ago in Plankstadt, Germany.

In Osaka, I sat spellbound listening to an old friend, Johann Mueller—the former plant manager at Plankstadt—talking about that same facility—still very advanced and efficient, capable of real-time control, and ahead of the curve. Cordon Pharma, a CMO and the current owner of the Plankstadt site, has allowed scientists with a passion for excellence to run and manage the facility. The presentation brought back many fond memories for me.  

NPTE’s goal is to share information about pharmaceutical technologies, practices, and innovations, and also to improve and to make the Japanese pharmaceutical industry competitive and prosperous. Japan understood and adopted the principles of W. Edwards Deming some decades back, and the auto industry worldwide changed. The same nation has now focused on pharmaceuticals for the sake of much needed change.

This conference was different: information and knowledge on how to facilitate improvement and growth in the industry was freely and openly shared. Each person’s goal was to contribute to the learning and success of others, and each saw his success in the success of others. I wondered: Was this unique to Japan or this conference? Or was it typical of Osaka, a city of trade for centuries?

Unlike at most of today’s technical pharmaceutical conferences, almost no mention of critical quality attributes or critical process parameters were made. Rather, the broader, most critical questions and challenges facing the industry, such as growth patterns, biotechnology, nanotechnology, and competitive advantage, were critically examined.

The recent global economic turmoil has not spared Japan or the Japanese pharmaceutical industry—the second-largest pharmaceuticals market after the U.S. Despite an industry slowdown and government price restrictions, there have not been layoffs, as this is not common practice.

Generics and a host of CMOs also exist in Japan. Generics do not have a large market share in Japan as, by law, they can only claim 20% of the market following patent expiry. This has an interesting impact on market dynamics. For instance, biosimilars have not taken off in Japan—perhaps due to the same legal restrictions or cultural principles—and it will be interesting to see how they are defined and regulated in the future.

What is clear is that pharma professionals in Japan are very eager to implement process efficiency and process excellence—be it  QbD, PAT, kaizen or any other optimization and excellence process.

And their approach is trying to address business and financial aspects within a culture of quality.

The most pressing issue for the pharmaceutical industry is seen as lower costs. So outsourcing to countries with low labor costs is often seen as the panacea and the solution. But the Japanese car industry has amply demonstrated that a cheaper manufacturing base is not necessarily the solution. Furthermore, the basic and fundamental requirements of any and every business are net profits, cash flow, and return on investment.

“A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drug products without extensive regulatory oversight” is not just a nice-to-have whim and wish of Dr. Janet Woodcock; rather, it is fundamental to the survival and existence of the industry.

Plankstadt was designed for efficiency, agility and flexibility; yet it was cast off due to the political machinations of a major pharmaceuticals company. Manufacturing facilities are moving away from the U.S. and Europe. There is even a drive away from small molecules to biologics, as the small-molecule pipeline has seemingly dried up. If moving away to regions with cheaper labor costs is the solution, then companies based in expensive countries such as Japan, Israel, and the Nordic region are doomed. This theory I do not subscribe to.

Long manufacturing cycles, large quantities of work in place (WIP), and manufacturing to inventory are among the major issues choking the life out of the pharmaceuticals business. Hence any business plan that manages the fundamentals should flourish. And I think once again Japan is about to listen to Dr. Deming and embrace his ideologies.

Congratulations to the organizers of NPTE for bringing together a group of experts, enthusiasts, and practitioners to facilitate change.

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