Puerto Rico Builds a Foundation for Biopharmaceuticals - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Puerto Rico Builds a Foundation for Biopharmaceuticals
Puerto Rico, long a mainstay of solid-dosage manufacturing, intensifies efforts in biopharmaceutical manufacturing and research and development.


Pharmaceutical Technology
Volume 6, Issue 34

As the pharmaceutical majors re-evaluate their manufacturing networks in consideration of cost-containment, shifting product development, and capacity needs, the manufacturing hubs that house that manufacturing also must adapt. Such is the case with Puerto Rico. Long a mainstay of pharmaceutical manufacturing, particularly solid-dosage manufacturing, Puerto Rico is focusing on not only providing the infrastructure and business support to retain current manufacturing, but is also intensifying its efforts to attract biopharmaceutical investment, both biomanufacturing and research and development (R&D).

Looking at the numbers

Puerto Rico is a significant site for pharmaceutical manufacturing. The commonwealth currently has more than 50 bio/pharmaceutical manufacturing facilities. Of these facilities, forty-five are for solid-dosage manufacturing, nine are facilities for manufacturing active pharmaceutical ingredients (APIs), and three are facilities for sterile manufacturing, according to data from the Puerto Rico Industrial Development Company (PRIDCO), the economic development arm of the commonwealth of Puerto Rico. The island also has five biopharmaceutical facilities, which includes biopharmaceutical manufacturing facilities of Amgen (Thousand Oaks, CA), Eli Lilly (Indianapolis, IN), Ortho Biotech, a subsidiary of Johnson & Johnson ( J&J, New Brunswick, NJ), Abbott Laboratories (Abbott Park, IL), and Becton Dickson (Miami, FL).

Manufacturing accounts for approximately 40% of Puerto Rico's gross domestic product of $93 billion, and life-science operations (pharmaceutical, biopharmaceuticals, and medical-device), represent 70% of the commonwealth's manufacturing activities, according to data from PRIDCO. Puerto Rico ranks itself on a global basis as the third largest biologics producer, the fifth largest pharmaceutical manufacturer, and the seventh largest producer of medical devices.

Adapting to change

One challenge that Puerto Rico faces, along with other pharmaceutical manufacturing hubs, is the rationalization of manufacturing capacity by the pharmaceutical industry due to cost-containment efforts and shifting product demand and mix. As a case in point, Pfizer (New York) announced in May its plans for restructuring its manufacturing network following its $68-billion acquisition of Wyeth (Madison, NJ) in 2009. According to a Pfizer press release, the company plans to discontinue manufacturing operations at its solid-dosage manufacturing facility in Caguas, Puerto Rico, and plans to phase out solid-dosage manufacturing at its facility in Guayama, Puerto Rico. The Guayama site will be expanded to include the company's consumer healthcare operations. Pfizer will also exit a sterile manufacturing facility in Carolina, Puerto Rico. The company will retain solid-dosage manufacturing in Barceloneta, Puerto Rico. The moves will be phased in over time as part of global and larger restructuring efforts by Pfizer. The timing of specific exits will depend upon the complexity of operations, the amount of time required for product transfers, and other business requirements.

"The pharmaceutical industry as a whole is undergoing change, but we think Puerto Rico has a strong and solid base in which to adapt to those changes," says Javier Vázquez, executive director of PRIDCO. That strategy involves attracting new pharmaceutical investment to the island, intensifying efforts to build its base in biopharmaceutical development (including clinical research) and biomanufacturing, and supporting efforts to facilitate the location and investment of suppliers and supply-chain companies to the pharmaceutical industry in Puerto Rico.

Transitioning assets. One approach taken by PRIDCO is to assist companies in the transition of existing assets through business incentives and other support services. A recent gain was the acquisition by the generic-drug manufacturer Blu Pharmaceuticals (Florence, KY) of a 145,000-ft2 FDA-approved facility in Dorado, which was previously owned by the generic-drug company Biovail (Mississauga, Ontario, Canada). Biovail announced in May 2008 that it would be phasing out its solid-dosage manufacturing facility in Dorado. Blu Pharmaceuticals' new facility in Dorado, Blu Caribe, opened earlier this year and is the first new pharmaceutical factory to open in Puerto Rico since 2007, when the generic-drug manufacturer Teva Pharmaceuticals (Jerusalem) acquired an existing manufacturing facility. Blu Pharmaceuticals plans to invest $60 million in the facility during the next three years. Plans call for Blu Caribe to manufacture seven drugs in the Puerto Rico facility, including ciprofloxacin, which is the antidote to anthrax. The company also has plans to establish an R&D operation within the Dorado facility, which has a pilot plant that will allow the company to run small batches of product under development.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: Pharmaceutical Technology,
Click here