Could combination products recharge Puerto Rico's pharmaceutical industry?

Attendance at the 2008 Interphex show in Puerto Rico February 14 - 15 was strong, despite the fact that the event's first day fell on Valentine's Day, an unofficial national holiday. Much of the talk at the San Juan event centered around the health of the pharmaceutical industry on the island as pharmaceutical giants such as GlaxoSmithKline have already departed while others are consolidating and closing plants. In fact, one pharmaceutical plant closed shortly after a new multimillion-dollar line was installed.

Some in the pharmaceutical community blame the local government for lack of action, but the industry on the island reflects the worldwide changes taking place in the pharmaceutical industry. The future could depend on how local companies convert from high-volume pharmaceutical packaging lines to shorter-run, high-tech biopharmaceutical product lines.

Overall comments concerning the emerging medical device sector in Puerto Rico were positive. A few medical device companies are adding new lines, with more firms expected to relocate to the island soon.

Neftali Tosado, senior engineer, process development, Amgen, a human therapeutics company in the biotechnology industry, delivered a presentation entitled, "Technical Overview of Packaging Lines and Product Inspection for Biopharmaceutical Products." He stressed the importance of early understanding of drug-to-package compatibility to lower costs. Packaging provides the first line of defense for all formulated pharmaceuticals, protecting the product from the outside world and vice versa. At the same time, the package must be fully compatible with the product, whether it is in a liquid solution or lyophilized.

Dr. Michael Drues' presentation on combination products drew a small but very interested crowd. "Almost every type of medical device would benefit from the addition of a drug or a biologic," Drues stated. When asked what division of the Food and Drug Administration regulates combination products, he responded, "That depends on how you define your product. If it's a device, you'll work with one area, if it's a drug, it's another. The Office of Combination Products was established to help these different agencies work together."

An interesting byproduct of Interphex Puerto Rico was the attendance of nonpharmaceutical/medical device companies. For example, there was a conveyor exhibitor visited by Coke, Pepsi, and BASF representatives. This may be the only opportunity for some of these companies to see packaging developments on the island.

The lack of innovation in packaging and product protection in the pharmaceutical industry was also discussed buy one materials-producing company. An innovative, thermoformable film used for blister-packs that incorporates anti-counterfeiting features never saw the light of day in the U.S. But it will be adapted shortly by a pharmaceutical company in South America. [HCP]

--By Don Neumeister, associate publisher