Medical Device Link.

CONTRACT PACKAGING

Providing one-stop solutions for “virtual companies” that lack packaging and manufacturing resources is a growth area for some packagers. These companies will often purchase older drugs on the downside of their life cycles, reformulate the ingredients, and intensively market them.

“Offering contract packaging to virtual companies has been a key RxPak initiative,” says Kevin Carter of McKesson (Memphis). “The brand companies are looking to get rid of small-run volumes that are killing efficiency or taking away capacity from other products. The virtual company will develop a formulation with the contract manufacturer, then outsource the packaging to us. We have contract manufacturing partners we use to provide a complete solution.”

Legacy Pharmaceutical Packaging (St. Louis) has teamed with Bayer Pharmaceutical Manufacturing Services (Shawnee, KS), Analytical Bio-Chemistry Laboratories (ABC; Columbia, MO), and MMS (St. Louis) in an alliance of contract service providers that offers an end-to-end solution to outsourcing pharmaceutical companies.

MMS is a distributor of cleanroom, production, and medical supplies, with nationwide contract warehouse and distribution capabilities. Legacy Packaging plans to add a fifth partner for drug product development, such as reverse engineering, and, ultimately, a contract sales force, says Wayne Welborn, president, Legacy Packaging.

“As a contract packager, we were missing opportunities. Up to a third of the inquiries that we received were from companies requesting manufacturing capability. In many cases, these were virtual-style companies,” says Welborn.

“We recognized the strategic value of broadening our services through partnerships with companies that specialize in their fields. Our competitive advantage is that every part of the process is handled by specialists. This is economical and a much smarter way of ensuring process quality,” Welborn says.

“We are expanding our alliance to position ourselves to do basically anything it takes to get a product from the development stage through to someone’s medicine cabinet,” he adds.

The partners cross-sell their services, providing customers with one point of contact.

Legacy formed the alliance with Bayer a year ago, following an extensive audit by Bayer of the packager’s facilities. “As a three-and-a-half-year-old company, we have had only one CGMP audit by FDA. We gained a lot of credibility through the Bayer partnership,” Welborn says.

The Bayer HealthCare facility in Shawnee is one of the company’s strategic manufacturing locations, where many brand-name Bayer HealthCare products are finished. These include Cipro tablets, Cipro IV, Avelox, Adalat, and Bayer’s new oncology drug, Nexavar. Bayer Animal Health division products, such as Baytril and Drontal tablets, are manufactured and distributed from this flexible manufacturing location, says Steve Meeker, director of site development, Bayer Pharmaceutical Manufacturing Services.

Meeker describes the Bayer facility as having the capability to formulate and package products of various forms, including parenterals, solid dosages, liquids, and creams. Laboratory testing and stability programs also can be managed at the Shawnee site.

“The I-70 Alliance offers a full portfolio of services. In some cases, Bayer can fulfill customers’ needs with turnkey programs and then introduce the full spectrum of capabilities available through the alliance,” Meeker says.

For example, Bayer may collaborate with Legacy for packaging in forms such as blisters, sample packs, and hospital unit-dose packs, while ABC could utilize Bayer’s testing capabilities.

“ABC can handle container extractables and leechables testing, in addition to a number of different laboratory and regulatory submission support services. If they have a capacity issue in their lab for in-process or finished-product testing, we have redundant capacity here,” Meeker explains.

“We have dedicated production capacity to support third-party partnerships. With our long history of pharmaceutical manufacturing at the Shawnee site, we can offer third parties an unsurpassed commitment to quality and compliance,” Meeker says.