Automation & Control

PAT in Perspective: To Outsource or Not to Outsource . . .

A consultant ponders the question, as it relates to NIR and pharmaceutical PAT projects that require a high level of hard-to-find technical expertise.

By Emil W. Ciurczak, Chief Technical Officer, Cadrai Group

Outsourcing has become the new paradigm in pharmaceuticals. I’m not talking about moving production — lock, stock and barrel — to nations where labor costs are lower, although we all know that’s happening, but outsourcing processes that are too expensive to “own,” whether a specialty packaging line, a novel process for producing dosage forms, or analytical instrumentation expertise for pharmaceutical process analytical technology (PAT) program development.

Outsourcing NIR and pharmaceutical PAT projects involving NIR brings in technical expertise that’s in short supply today. It also brings in a fresh, unbiased point of view, and can cut through the politics and turf battles that have stymied PAT projects at all too many pharmaceutical companies.

I have seen any number of pharmaceutical companies’ PAT committees fail because they couldn’t organize, or develop a coherent strategy for implementing PAT. Simply placing 12 or 14 people who don’t have experience with NIR or PAT into a room will not spontaneously generate expertise.

Pharmaceutical managers generally like the concept of outsourcing. It’s easy on the budget, and for esoteric, once-in-a-lifetime projects, why buy the truck when you can rent it? For esoteric projects like software validation or LIMS implementation, consultants are only a phone call away.

D-I-Y PAT?

With NIR and PAT, though, the situation is quite different. In a typical pharmaceutical industry scenario, when a company is first considering rolling out a PAT project, a smart analyst will ask his or her supervisor for outside help, and an astute supervisor will ask management for the funding required.

The response they’ll typically hear has all the inertia of tradition behind it: “You developed 200 HPLC methods without a consultant. You learned mass spec and are applying it without a consultant. You use infrared, UV/Vis, and fluorescence without the help of a consultant. Just do what you’ve always done; learn it yourself.”

That’s because the typical manager sees PAT as just another technical problem to be solved by his or her resident analysts. Of course, you know differently: PAT isn’t just about technology. It’s really analysis, engineering, software, formulating, economics, validation, and the list goes on.

But today, few people at the average drug company have any experience with NIR. Even fewer have a grasp of PAT. Both of these points can make a compelling argument for outsourcing PAT.

When I worked for a pharmaceutical company, I can’t remember ever hiring a consultant for HPLC, other than signing up a specialist to teach the occasional short course or give an in-house lecture. In even the smallest of companies, there are likely to be quite a few people skilled in chromatography.

It’s different for MS and NMR

In fact, as more drug companies seek the assistance of instrument manufacturers, even techniques such as mass spectrometry and NMR are usually “home grown.” But, for these techniques, If there is no one in-house with the expertise required, applications people at the instrument vendor company can usually help out. If they’re not available, at least these subjects are taught in school, and there is always a course to take or a professor to speak with.

Now, with pharmaceutical PAT, the pharmaceutical industry is confronted with two techniques — often mentioned together — that are not typically taught in school: near-infrared (NIR) spectroscopy and PAT.

As a result, pharma companies embarking on PAT programs that involve NIR face the following conditions:
  • NIR vendor companies that, typically, have few resident applications experts (and few of them with pharmaceutical backgrounds);

  • A subject whose theory and practical aspects aren’t typically taught in universities;

  • Few other scientists in the company who know enough about the technique to assist a start-up.
So what’s a chemist to do, especially given today’s emphasis on lean operations and “doing more with less?” Short courses are problematic. NIR may have humble roots in agricultural projects, but using it for pharmaceutical PAT can be complex — not the spectroscopic theory part, perhaps, but knowing how to apply the elements of statistics, physics, optics, and chemometrics that are required to make pharmaceutical PAT work.

Even if your company has the bandwidth required to train and staff NIR PAT projects internally, politics may lead to gridlock. Your colleagues are all smart enough to handle PAT, but in most drug companies, each person not only is a specialist, but has his or her “turf” to defend, and sees every problem from his or her own point of view.

Consider the PAT consultant your personal “MapQuest” to success. Map courtesy of MapQuest.



In any work situation, if the only tool you have is a hammer, every problem resembles a nail. And, since everyone within the company is “equal,” and each wants to apply his or her own hammer, it can be extremely difficult to promote one viewpoint over another. These situations make an outside expert extremely valuable.

Then, even if you do gain high-level support for PAT outsourcing, where do you turn? There aren’t a million PAT and NIR “experts” out there waiting for your call.

It’s not only important for the success of your PAT program that you check any expert’s references closely, it’s legally required by the Code of Federal Regulations (21 CFR 211.34), which explicitly states that pharmaceutical organizations ensure consultant’s qualifications. If and when you do decide to work with an outside consultant on NIR and PAT, check his or her credentials closely — and follow up with former employers and take the extra step of looking up publications and patents.

As pharmaceutical industry professionals, you already outsource so many projects, why not outsource PAT, and rent the expertise you need until your own teams can carry out PAT projects independently? An unbiased view, from an outsider with the right experience, can save a lot of time. Of course, I’m a consultant so my view may be biased, but I have worked on the other side of the fence, and there is a small but growing cadre of NIR and PAT experts out there who can help get your PAT initiatives off the ground.

How to go about outsourcing is the subject of another column. But, remember, it isn’t a sign of weakness to ask for directions when you’re lost, guys. Consider the PAT consultant your personal “MapQuest” to success.



About the Author

Emil W. Ciurczak has more than 35 years experience in pharmaceutical manufacturing, analytical R&D, and regulatory compliance. He was a member of the validation subcommittee for the Pharmaceutical Advisory Committee for FDA and a consultant to the FDA.

He is the co-author or co-editor for several texts, including Handbook of Near-Infrared Analysis (1st & 2nd ed) and Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy. He is also Contributing Editor to Spectroscopy and is on the Editorial Boards for American Pharmaceutical Review, JPAT and Journal of NIRS.

Ciurczak holds a B.A. and M.S in Chemistry from Rutgers University and an M.S. in Chemistry from Seton Hall University. He holds patents for both instruments and software relating to spectroscopic analyses and has over 60 publications.

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