From the Editor: Who Needed PAT and QbD, Anyway?

Has the industry been on the road to Oz? Didn’t we already have what we needed…in the GMP code and good engineering principles?

By Agnes Shanley, Editor in Chief

This month brought some very unexpected news. Two electronics manufacturers, South Korea’s Samsung and Japan’s Fujifilm, have entered the global biopharmaceuticals business in a big way. Fuji acquired two Merck contract manufacturing subsidiaries, Diosynth in the U.S. and MSD Bio in the U.K., while Samsung will be partnering with Quintiles on biosimilars development.

Were these simply two zany moves that don’t really fit into the companies’ business plans and will be regretted later? No way. Fuji had systematically laid the groundwork for this a while ago, when it established a pharma company with Japanese partners.  
Key targets include an area where big name brand and generics companies aren’t performing all that well: cancer drugs (now in extremely short supply here in the U.S).

The whole idea of companies from an industry with a manufacturing focus, and a nine-sigma-plus manufacturing environment, moving into pharma, especially biopharma, is interesting. What in-house analytical knowhow might these companies have, which might be applied to pharma processes? Will they throw the traditional pharma view of manufacturing on its head and leave big pharma struggling to catch up?

How soon can established drug manufacturers, including generics companies, change their approach to development and manufacturing? Are the newer concepts of process analytical technologies (PAT), Quality by Design (QbD) or process validation helping or hindering this change? After all, other industries, including electronics, never found it necessary to create whole new acronyms.

But highly regulated pharma is different, you say? For all our support of smart, science-based quality and efficiency methods, I’ve had to ask myself recently if the industry hasn’t been on a yellow brick road of sorts, like the travelers in the Wizard of Oz who set off on an impossible quest, only to find that they already had what they needed. In today’s competitive environment, do they even have time for the quest?  

Despite all the clarity and science behind the new process validation guidance, why do so many people still grumble about it, and how expensive it will be? Why do PAT and QbD still elicit polite mumblings about quality imperatives and motherhood and apple pie, but relatively little interest in the mainstream? So much of what has been argued for—more intelligent sampling and an end to the “three batches” mindset, quality systems, process control, and even QbD—is already in the cGMP’s. Add to that the power of materials science and chemical engineering, and pharma already has everything it ever needed to advance.

So, at times, one wonders, why was it necessary to develop the three-letter acronyms that pharma wrestles with today? Can pharma synthesize a new vision incorporating the new thinking, and the acronyms of the past decade, in a way that enhances buyin? As the old classics remind us, the journey is at least as important as reaching the goal. But time is of the essence.

Several conferences are coming up to remind us of the goal—a PAT and QbD meeting in April that will bring together practitioners from industry and FDA, but also a June conference that will present, and allow discussion and detailed comments on, new case studies for solid dosage form scaleup and explore its connection to the Critical Path.

This month, NIPTE and IPEC will start discussions that aim to bring basic materials science knowhow to bear in the quality control of excipients. We’ll bring you whatever insights we can from these meetings, and from Interphex, PDA and BIO, all of which are coming up.  We’re living in interesting, if confusing times. Let’s make the most of them.

Show Comments
Hide Comments

Join the discussion

We welcome your thoughtful comments.
All comments will display your user name.

Want to participate in the discussion?

Register for free

Log in for complete access.

Comments

No one has commented on this page yet.

RSS feed for comments on this page | RSS feed for all comments