Automation and consolidation have affected pharmaceutical companies worldwide, and Puerto Rico is no exception. The island has benefited from the trend towards lower volume, higher value products which often use the smaller plants Puerto Rico offers. Some companies, like Merck, are transforming their sites from pure manufacturing to commercialization. These trends point to a reorientation of strategy for manufacturing in Puerto Rico.
The frantic rush to create an automation-driven manufacturing environment, coupled with the impact of global consolidation is being felt throughout the island. “In terms of technology, everything is moving towards being more automated,” says Tom Forrester, president of engineering and architectural design firm CRB Caribe. “We are seeing a move in Puerto Rico towards biopharmaceutical products and processes in the oral solid dosage area finishing and packaging and less in the APIs.”
Ricardo Zayas, senior vice president of global pharmaceutical manufacturing at Bristol-Myers Squibb (BMS), says that product volume and technology trends have become an increasingly important part in the future of pharmaceutical manufacturing networks and individual facilities. “Consolidation has created a significant amount of excess capacity in small molecule manufacturing around the world, prompting companies to repurpose, close or sell their facilities,” emphasizes Zayas. “Companies focused on innovative science are moving towards lower volume, higher value products. The challenge is that many plants were not designed for this model and will have to redefine their mission, strategy and operating model. Smaller plants that optimize space utilization are better equipped to handle changing demands of the industry. This is especially true in Puerto Rico where energy costs are relatively high.”
“An increase in production volumes does not necessarily require the addition of many people because processes are highly technological and automated; thus you can absorb increases or decreases in demand easily” – Lourdes de Cárdenas, Stryker
In addition to the “smaller is better” mantra, according to Zayas the convergence of development with production makes great sense. “First launching in market, then a rapid deployment to target markets around the world can help get medications to the patients who need them,” he stresses. “The primary focus during the development to launch process in terms of lead time has typically been the clinical and regulatory processes, but in today’s world, any time the manufacturing and development teams can work together to reduce the development-to-launch cycle time provides a significant opportunity to accelerate timelines.”
Lourdes de Cárdenas, vice president of operations Latin America for Stryker, notes that the intellectual value that Puerto Rican engineers adds makes the island particularly productive: “An increase in production volumes does not necessarily require the addition of many people because processes are highly technological and automated; thus you can absorb increases or decreases in demand easily,” she says. One of Stryker Puerto Rico’s goals is to continue integrating automation into its processes. “This poses a certain degree of difficulty because of the variety of products we manufacture but moreover our approach to automation is not necessarily automating a process completely,” explains de Cárdenas. “It is automating unit operations that repeat themselves among different processes. Once those technologies are perfected you can reproduce them across many different lines. Consequently, demand can be easily managed.
Merck is no stranger to these trends. In the last two years, the company sold two of its three plants in Puerto Rico and is redefining its strategy at the remaining plant in Las Piedras. This plant has undergone a USD 100 million investment since 2011 focused on transforming the site from a basic supply site to a commercialization site, which CRB Caribe played a significant role in designing.
“A commercialization site has the responsibility of shepherding new chemical entities (NCEs) from proof-of-concept to commercialization in the marketplace – which is a far more dynamic objective,” remarks Andrew Wirths, associate vice president and general manager of Merck’s Puerto Rico pharmaceutical operations. “Taking a plant site with five products producing one billion tablets for many years and adding several more products with new launches means an increase in capability, speed, cadence and cost competitiveness. We get really involved at the Phase IIb level, in terms of scaling it up, supplying clinical, and going full-scale commercial depending on the forecast.”
Merck’s facility in Las Piedras obtained a commercialization certification in part because the facility itself was suited to the change in mission. “With non-sterile oral dosage, powders are blended and granulated and pressed into tablets,” explains Wirths. “It is simpler in some ways to the large molecule space, but we have consolidated commercialization activities here, de-risking the business by putting all the MKs in Puerto Rico from a cost perspective. I do not have to recapitalize because I have a very flexible facility where I can make different drugs with different technology platforms embedded here. If a new product does not succeed, I do not lose that much.”