Contract and Clinical Trial Packagers Meet Great Expectations

 Diversity is key for contract packagers whose customers seek innovative ways to stimulate business.

Kassandra Kania

These are challenging times for industry—and contract packagers are working closely with customers to come up with creative ways to package products. Some companies have witnessed a slowdown due to the lack of new drugs entering the marketplace. But contract packagers are meeting this challenge with innovative drug-delivery forms.

“It’s a tough business,” notes Scott Denley, marketing manager of Alcan Packaging’s pharmaceutical flexibles business unit (Shelbyville, KY). “There are fewer product launches, and as a result contract packaging companies are having to develop new and innovative products and services to stay competitive.” Some companies are pulling manufacturing back into their plants to maintain their manufacturing expertise, he says. Others are seeking alternate forms of drug delivery to revive their products.

“If you can’t get new products approved, you look at line extensions or a new way of delivery,” says David Phillipes, vice president sales, specialty packaging division of Caraustar (Ashland, OH). Companies are trying to be innovative, he says. For example, thin strips are becoming more commonly used for a wide variety of medications. “The days of running standard blisters, standard bottles, and two-count pouches are over,” says Phillipes. “Today, 50% of our business is very specialized off-line custom machinery and requirements.”

Renard Jackson has also seen business impacted by new drug-delivery formats, in particular thin-strip film technology. Jackson is executive vice president of sales and business development for the packaging services business of Cardinal Health (Philadelphia). The company has developed a child-resistant unit-dose pouch for OTC and prescription products offered in a thin-strip format. “More and more, we’re seeing companies looking for help in innovation,” says Jackson. For example, companies want “innovative package designs and child-resistant/senior-friendly packaging. OTC companies are also looking for bolder, brighter packaging components.”

Expanding Services
 

Fisher Clinical Services Inc. offers clinical trial packaging services for investigational drugs.

Along with innovative products, contract and clinical trial packagers are recognizing the need to offer a host of services to stay competitive. Companies are looking for one-stop shopping, says Joseph Urban, senior director for ProClinical Pharmaceutical Services (Phoenixville, PA). “In the upcoming year, the contractor’s role will be the delivery of more services in a more time-efficient, cost-effective way through bundling as many services as possible,” he adds.

Another expanding area that is changing the contract packager’s role is the growth of biotech and sterilizable products. As these products become more prevalent, Denley has noticed that packaging alone is not enough. “Contract packagers will need to combine competencies in both manufacturing and packaging.”

Jeff Hallquist, sales director of Fisher Clinical Services Inc. (Allentown, PA), foresees more specialized pharmaceutical companies and virtual biotechnology companies taking on the drug development challenge. As a result, contract and clinical trial packagers will see a higher demand for cold-chain management of large-molecule-derived investigational materials, he says. “CGMP-controlled ambient, refrigerated, and frozen storage; packaging; and distribution environments will be demanded to protect the quality and safety of the investigational materials. Greater control of the supply chain will be required as well as control of the demand chain. These higher levels of control require validated shipping methods, tracking devices, and distribution IT systems with a dashboard of informational screens containing relevant activity reports, such as site inventory levels, patient enrollments, kit assignments, and shipping activity.”

Clinical trial packaging is also evolving. “Trials are becoming larger, spanning the globe; longer with multiyear campaigns; and more complex with multiple arms including innovator drugs, comparator drugs, and placebo drugs with multinational trials,” says Hallquist. These trials require multilingual labeling and a higher level of QA and regulatory oversight, he notes. “Additionally, technology continues to have the greatest impact, with new demand for tracking and accountability systems, such as those using bar codes and RFID as it becomes more available.”

Strength in Numbers

Jackson has also noticed that RFID requirements of retailers such as Wal-Mart have more companies turning to contract packagers for help in developing a brand protection strategy. This trend, coupled with a growing demand for unit-dose bar coded products, should provide a boost for the contract packaging business. Figures from the Packaging Machinery Manufacturers Institute (PMMI; Arlington, VA) also suggest that the contract packaging industry remains strong. According to the annual Packaging Machinery Purchasing Plans Study, conducted by PMMI, 23.6% of respondents reported that the volume of packaging they farmed out to contract packagers increased in 2003 over 2002, and 11% of them expected the volume to increase again in 2004.

“Packaging is oftentimes not a core competency for pharmaceutical manufacturers the way it is for contract packagers,” notes Sidney McFadden of American Health Packaging (Columbus, OH), a company offering contract-packaging services. “It makes sense for pharmaceutical companies to outsource that piece of the process so they can focus on what they do best—drug development.”

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