Green Processes: PAT and QbD Take Root

Leveraging PAT and QbD promises significant environmental dividends

By Paul Thomas, Senior Editor

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Like all industries, pharma is riding the green wave. (See “Pharma’s Green Evolution”.) Many drug manufacturers, in fact, are now models of environmental stewardship. They’ve picked the low-hanging fruit on a facility level (optimizing HVAC, using high-efficiency lighting, for instance), and are now zeroing in on their manufacturing processes—looking to reduce materials consumed and waste produced, cut cycle times and thus energy and equipment usage, and optimize processes, not only to get drugs to market sooner but to reduce the overall environmental impact of development and commercial manufacture.

We surveyed a small segment of our readers (just over 50) to gauge the industry’s efforts to make its processes less wasteful and more environmentally friendly. We also wanted to discover what role Process Analytical Technologies (PAT) and Quality by Design might be playing in these efforts. Here is a summary of what we found, and what expert observers are seeing.

 

Competitive Advantage

 

To no surprise, waste and cost reduction, along with energy savings, are the most significant drivers of manufacturers’ efforts to green their processes (Figure 2). The other items on the list, of course, speak to those goals as well.

PAT and QbD
PAT and QbD
PAT and QbD

Green and sustainable processes present a competitive advantage, says Mike Whaley, Allergan’s senior director for Environmental Health and Safety. They represent opportunities for cost savings, additional revenues, and cost avoidance, he says. As such, sustainable processes win favor with investors and customers.

Allergan’s “improvements in product design and processing complement one another to achieve cost savings,” Whaley says. “In particular, a more efficient process results in greater production capacity, easier and more predictable manufacturing, less waste generated, and cost savings.”

If green is good for business, why isn’t everyone pursuing processes that use fewer solvents or less water, produce less waste, or consume less energy? Validation and regulatory concerns are the top obstacles, our survey respondents said (Figure 3). Manufacturers may pay lip service to changing their processes for the better, “but the body language tells you that they are afraid of the regulatory risk,” says Jack Carroll, managing partner of Cadrai Technology Group.

A lack of time and qualified people is also an understandable concern, Carroll says. Operations management may see the benefit of greening manufacturing processes, but do the benefits outweigh the opportunity costs of not pursuing other projects, and having your best people working on those other projects?

 

Leveraging PAT

Manufacturers are just beginning to equate PAT with reducing the environmental impact of processes. Ten percent of survey respondents said that sustainability had become a key driver of their PAT efforts, while approximately half said that they look at PAT with an eye towards sustainability or green practices (Figure 4). As one of our respondents said, “Process control is environmental control.”

GSK may be ahead of the curve in this area. Darryl Ertl, manager of GlaxoSmithKline’s PAT group in the Research Triangle Park, has seen a dramatic shift within his own company in just the last six months in terms of the acceptance of PAT as a vehicle for sustainability, and cost savings. Whereas in the past PAT was equated with process control, and implemented primarily ad hoc in commercial manufacturing, it has recently moved up in status, and moved upstream in the development cycle. 

GSK’s pilot plants, in looking to reduce cycle times, save energy, and cut costs, have gravitated towards PAT. “We used to have to push these initiatives,” Ertl says, “but now the pilot plants are saying, ‘We want to do these things. We can save a significant amount of money.’ It’s a pull vs. push mentality.”

Just this spring, GSK established a worldwide team, with one representative at each pilot facility, to promote the use of PAT to determine the endpoints of drying operations. NIR and mass spectrometry are the two specific technologies being leveraged. A catalyst for the team, Ertl says, was preliminary data out of GSK’s Cork, Ireland facility that illustrated clear and significant benefits of reducing cycle time for several key late-phase molecules.

That PAT can support corporate environmental objectives means that it will continue to gain favor as a mechanism for sustainability. “It doesn’t have to be a big bang,” Ertl says. Small and incremental improvements in developing green and sustainable processes will reap sizeable benefits in the long run.

 

QbD: Green by Nature?

 

Ertl, interestingly, does not see Quality by Design as going hand in hand with sustainability. QbD’s guiding premise (at least how it is practiced in industry) is to get drugs to market faster, with greater quality, which can come at the expense of efforts to reduce waste, use fewer solvents, and so on.

David Ager, principal scientist for DSM Pharmaceuticals, also questions whether QbD directly supports green practices. As a CMO, DSM is under pressure from the customer to be “first time right,” Ager says. “QbD helps us in this effort, especially when a candidate moves down the development pipeline. But QbD and the sustainability considerations have to be taken as two different variables, and for drugs, quality is the dominant factor.”

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