New Products Challenge Clinical Trial, Contract Packagers

Pharmaceutical companies are placing increased demand on clinical and contract packagers—not only to produce volume, but also to develop and share new levels of expertise.

by Annie Lubinsky

Pharmaceutical companies have high expectations of contract and clinical packagers—to work as a partner, to share expertise in specialized areas, to produce the volume required on time, and to fulfill regulatory requirements. Contract and clinical packagers have shown that they can rise to just about any occasion, to the delight of pharmaceutical companies. Relationships between these companies continue to be successful—so successful that use of contract and clinical packagers is growing.

GROWTH OF CONTRACT PACKAGING

Recognizing the continued use and growth of contract packaging, the Packaging Machinery Manufacturers Institute (PMMI; Arlington, VA) introduced the Outsourcing Resource Pavilion at Pack Expo Las Vegas in October 1999. According to Matt Croson, PMMI's director of communications, there were 10 exhibitors there and also 10 exhibitors at Pack Expo International, which was held in November 2000. "The Pavilion was well received," says Croson. "Use of contract packagers is an ongoing trend. More and more companies are looking to leverage the flexibility of contract packagers to get new products out and try new things with packages without having to invest in a complete line or facility."

According to the PMMI 2000 U.S. Packaging Machinery Purchasing Plans Study, 56.6% of companies surveyed currently use contract packagers for some or all of their packaging requirements (see Table I). This is an increase of 3.2% over last year. Most of the companies surveyed—73.5%—said that their use of contract packagers would remain at about the same level as in 1999. "The abiding reliance on contract packagers," the study states, "is largely attributable to overburdened production operations, temporary swings in product demand, and a shortage of available labor. But also of major impact on decisions is the flow of new products to the market, as more manufacturers farm out the initial packaging until the product's success or failure is established."

 19992000
Companies that use contract packagers53.4%56.6%
Companies that plan to increase use of contract packagers17.5%18.3%
Companies whose use of contract packagers will remain the same 73.5%73.5%
Companies that plan to reduce use of contract packagers9.0%8.2%
Table I. Two years' results of the PMMI Packaging Machinery Purchasing Plans Study. Source: PMMI.

TO OUTSOURCE OR KEEP IN-HOUSE?

Most of the companies that are reducing their use of contract packagers—8.2% in 2000—are "bringing packaging back in-house as a means of reducing packaging costs," says the PMMI study. Often this decision is part of the normal life cycle of the product—a clinical packager will see the product through clinical trials, then a contract packager will handle the product launch, after which the pharmaceutical company may purchase the necessary equipment to manufacture and package the product in-house. The decision varies from company to company and from product to product.

Tom Jeatran, director–clinical trial materials at Cook Pharmaceutical Solutions (Bloomington, IN), says that the decision to either continue or discontinue using a contract or clinical packager is based on the type of company and the type of product. "If the pharmaceutical company is using a clinical packager, then, when the product is ready to be placed on the market, the company may prefer to package the product in-house if it has the resources," says Jeatran. "However, if the company does not have the resources, it has to look for them. If the product is a tablet or capsule, usually the company will have the resources to produce the product in its own facility. A very small company may have limited in-house resources, and a very large company may find it less expensive to allow the contract packager to produce the product."

In other cases, Jeatran points out, the drug itself will determine which company carries out the packaging operation. "Many companies lack sufficient resources to manufacture and package parenteral drugs such as prefilled syringes and lyophilized vials," he says. And some of the new drugs coming out of genomic research typically take the form of proteins and peptides, substances that need to be injected. A pharmaceutical company introducing these new products to the market will need to find a contract packager specializing in parenteral drugs if it does not have the needed resources in-house.

CLINICAL PACKAGERS RESPOND TO NEEDS

Clinical packagers too have seen more business over the past few years, according to Keshav Sharma, business development manager–clinical trials of Westvaco's Consumer Packaging Group (Richmond, VA). "The number, frequency, scope, and length of pharmaceutical clinical trials have risen significantly over the past few years, as drug companies find themselves under mounting pressure to develop and launch new drugs," says Sharma. "A focus on drugs that extend longevity and improve quality of life, for example, has led to an increase in the number of clinical trials involving elderly patients. Outpatient trials are also accelerating, as more patients are enrolled for longer studies. As these trends have accelerated, so have the demands on clinical trial packagers."

Sharma points out that clinical trial packagers are under pressure to create packaging that is both child resistant—in compliance with Consumer Product Safety Commission requirements—and senior friendly—to minimize patient frustration and enhance compliance. Because speed to market is a top priority among pharmaceutical companies, clinical trial packagers must carry out their functions in a timely manner as well.

"The current market for clinical packaging is characterized by compressed timelines, flexibility in design, and the need for constant vigilance in monitoring regulatory shifts like those requiring child-resistant attributes," Sharma says.

To assist pharmaceutical companies in achieving their goals, Westvaco employs a custom approach to meeting clients' needs in the time required. The company will also look at its clients' operations to determine where improvements can be made and costs reduced.

FINDING A PARTNER

Clinical trial and contract packagers know that acquiring and keeping new clients is an important part of their business, where new products constantly come and go. Companies looking to meet your particular needs—
from high-speed capsule manufacturing to randomization services and clinical trial labeling—are featured on the following pages.

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