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Brief pharmaceutical news items for March 2010.

Pharmaceutical Technology
Volume 34, Issue 3

IPS Seeks Participants for Tooling Study

The Industrial Pharmacy Section (IPS) Expert Group, created at the 69th International Congress of the International Pharmaceutical Federation in Istanbul by representatives of Schering-Plough (Kenilworth, NJ) [now Merck (Whitehouse Station, NJ)], the University of Basel, and Natoli Engineering (Saint Charles, MO), is searching for companies that are interested in contributing to the Group's latest study of tablet tooling and sticking.

With increasing demand for high manufacturing speeds, tablet quality, and direct-compression formulas, the issue of sticking is receiving much more attention. The IPS Expert Group is seeking companies that have experienced and solved or are currently experiencing this production issue. Companies interested in providing information about their sticking issues and resolutions should contact Tom Sam at
.

Sartorius and Corning Collaborate

Sartorius Stedim Biotech (Göttingen, Germany) and Corning (Lowell, MA), international suppliers to the pharmaceutical and biotechnology industries, entered into a comarketing and branding collaboration. The companies will comarket various cell-culture products through a combined product catalogue and work together on several marketing and sales initiatives. The companies are exploring best options and approaches for future research and development efforts and joint product development.

Catalent Adds Potent-Drug Capabilities

Catalent Pharma Solutions, (Somerset, NJ) a provider of outsourced dose-form manufacturing and packaging to the global pharmaceutical industry, expanded its capabilities in its Schorndorf, Germany, site to include a new potent-products area. The new capability enables Catalent to provide customers with complex and innovative dose-form production, overencapsulation, and packaging solutions for potent products at its Schorndorf site. In the fall of 2009, Catalent's Schorndorf facility successfully completed an inspection by the US Food and Drug Administration.

Keystone Launches New Website

The Keystone Folding Box Company (Newark, NJ), a provider of pharmaceutical packaging solutions, launched a new product-based website at http://www.keypakcard.com/.

The site is dedicated to the company's Key-Pak product, an F=1 child-resistant, senior-friendly blister card that provides a solution for clinical trials, titration dosing, physician's samples, and prescription pharmaceuticals. The site is designed for easy navigation and offers users information about the advantages of blister packs over bottles. The site also describes the benefits of the Key-Pak product for clinical trials and commercial pharmaceuticals. In addition, the site offers an animation that demonstrates how Key-Pak works in the hands of a patient. An online application is available for clients who would like to request samples.

Q &A with
Shaun Newlon, vice-president of manufacturing at Baxter International



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.

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