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Baxter International's Shaun Newlon on Manufacturing Trends

March 2, 2010
Publication
Article
Pharmaceutical TechnologyPharmaceutical Technology-03-02-2010
Volume 34
Issue 3

The vice-president addresses shifts in process and more.

Shaun Newlon

PharmTech: Do you see a new industry trend emerging?

Newlon:

For solutions, I see a trend toward the production of more biologic agents, rather than conventional, chemically synthesized drugs, which translates to a major shift in manufacturing processes. With the higher value of biologic active ingredients, our manufacturing risk of loss increases. We have seen a strategic shift away from traditional economies of scale and high-speed lines toward small batch sizes with the goal of eliminating scrap and minimizing losses. Our manufacturing systems must be designed for more agility instead of our traditional focus on high run rates.

I also see a trend toward greater use of contract manufacturing services. Small biotech firms and large pharmaceutical companies are identifying manufacturing capability gaps or focusing internal assets on research activities, which spurs them to seek outside manufacturing as extensions of their own operations. Contract manufacturing plants must be customer-oriented entities that provide services and deliver products.

PharmTech:

What is the most common demand your clients are currently making of you?

Newlon:

One of our most regular client demands is the concept of available capacity on demand, especially in contract manufacturing. The desire for instant access and instant response has permeated our collective consciousness, and that extends to pharmaceutical manufacturing. We have to recognize immediacy as a customer expectation and design our contracting and planning systems accordingly. Although not always easy to manage, it's a necessary part of our successful business model.

Another request we get is to have greater flexibility in the quality agreements that define and govern our daily operating parameters. It is extremely challenging for two companies, each with different risk profiles, to be comfortable with the particulars of each other's quality systems and make them work in complementary fashions in a strict global regulatory environment. The good news is that people in our industry are passionate about acting responsibly to do what is right for patients.

Articles in this issue

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In the Spotlight March 2010
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Time for a Model Upgrade
Report from India
Report from India
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Navigating the Global Pharmaceutical Supply Chain
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Industry Pipeline
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Statistically Justifiable Visible Residue Limits
Spherical Crystallization for Lean Solid-Dose Manufacturing (Part 1)
Spherical Crystallization for Lean Solid-Dose Manufacturing (Part 1)
i1-660532-1408626622084.jpg
Consumers Need Access to Lower-Cost Biogenerics
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Uptick or Sustainable Growth?
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Pharma Capsules
Opportunities in the Biosimilars Market
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Health IT Promises More Timely Drug Information
Quick Saves and Near Misses
Inside IPEC: Excipient Pedigree as a Supply Chain Tool
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Skinny or Dead
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