Cambrex’s Journey in Pharma Manufacturing

Over the past 29 years, Cambrex Corporation has strategically ac­quired complementary resources and technologies to achieve growth and success in manufacturing small molecule active pharmaceutical ingredients (APIs). Working with multinational and small or emerging pharmas, Cambrex excels in difficult areas of chemistry and has the experience to take customers through development, scale-up and the manufacture of commercial volumes of branded and generic bulk APIs.

Cambrex’s North American locations include headquarters in East Rutherford, N.J., and its bulk active pharmaceutical ingredients research, development and cGMP manufacturing operation – Cambrex Charles City Inc. – in Charles City, Iowa. The company focuses on high-energy reactions, biocatalysis and custom manufacturing at its Cambrex Karlskoga cGMP facility in Sweden. Alfred Nobel founded an explosives operation there, which became Nobel Chemicals AB and then Cambrex Karlskoga in 1994.

Generic APIs are developed and manufactured under cGMP at Milan, Italy-based Cambrex Profarmaco. Cambrex Tallinn in Estonia, formerly known as ProSyntest Ltd. and acquired in 2008, provides custom organic synthesis and contract R&D.

“Cambrex continues to focus on implementing strategies to grow our portfolio of late-stage clinical projects, long-term manufacturing agreements for approved branded and generic APIs and our drug delivery and controlled substances businesses,” President and CEO Steven M. Klosk says. “In addition, we are expanding our platform of products and services based on core proprietary technologies. For example, Cambrex’s most recent acquisition of IEP GmbH [in] Wiesbaden, Germany, in March 2010, has strengthened our biocatalysis platform for pharmaceutical drug development.”

A Competitive Edge

Due to operating in a heavily regulated market governed by the U.S. Food and Drug Administration (FDA) and other international regulatory or­ganizations, quality and process are tightly controlled at Cambrex. Importation of certain controlled substances for pain management and central nervous system (CNS) indications into the United States is prohibited by federal law. As a manufacturer of controlled substances, Cambrex has positioned itself to take advantage of reduced international competition in the U.S. market for these products. However, domestic competition in this market is intense and its facilities must remain in strict compliance with the Drug Enforcement Administration’s (DEA) laws and licensure.

“We work with the FDA and DEA on best practices and have an exemplary regulatory record,” says Eric Neuffer, vice president of sales and business development. “Clients scrutinize our regulatory performance closely because the FDA and DEA have the power to shut down non-compliant facilities, and customers know that such an occurrence would mean a catastrophic disruption of their supply chain and their businesses.”

Tactical growth initiatives – including an investment of more than $225 million in upgrading its facilities worldwide – support the company’s move into the specialized areas customers require, like the handling of High Potency APIs (HPAPIs).

“The demand for HPAPIs is estimated to be nearly double that for non-potent compounds,” Neuffer explains. “Most of the drugs on the market currently classified as potent are cancer therapies.”

Developing unique drug delivery approaches like its polymer-based controlled release technologies, and introducing techniques like biocatalysis – which employs enzymes to perform chemical transformations – are examples of how Cambrex has adapted to challenges in today’s global marketplace. “Biocatalysis can eliminate several steps from a manufacturing process and provide higher quality material at a more competitive price,” Neuffer says.

When time waste decreases, throughput and productivity rise. “Our goal is to maintain quality, while minimizing both raw material usage and time,” Neuffer emphasizes. “Every department has a role in en­suring Cambrex’s products are delivered to our customers on time at a competitive price.”

Forward-looking Technology

Continuous-Flow Microwave-Assisted Organic Synthesis (CF-MAOS) equipment developed by Cambrex uses microwave energy rather than thermal energy to perform chemical conversions in solution and slurry flow. The CF-MAOS technology is not only scalable and highly efficient, it uses a very small footprint on the manufacturing floor, adds Neuffer. Some additional advantages include faster reaction rates, higher yields, better reproducibility and waste reduction. Innovative thinking followed by demonstrated advancements, according to Neuffer, will allow Cambrex to retain and to grow its global market share.