Pfizer Outlines Biomanufacturing Strategy

A key strategic rationale for Pfizer’s (New York) $68-billion acquisition of Wyeth (Madison, NJ) was to augment its biopharmaceutical product portfolio, pipeline, and related development and manufacturing capabilities. In May 2010, Pfizer detailed its plans to reconfigure its global manufacturing network as part of its integration of Wyeth. A key aspect is the company’s biomanufacturing capabilities.

Manufacturing reconfiguration
Pfizer’s biomanufacturing strategy is part of a plan for the company’s overall manufacturing and supply network. The implementation of the first phase of Pfizer's overall network strategy includes recommendations to cease operations at eight manufacturing sites in Ireland, Puerto Rico, and the United States by the end of 2015 and a reduction of operations at six other plants in Germany, Ireland, Puerto Rico, the United Kingdom, and the US, according to a May 2010 Pfizer press release.

Pfizer plans to discontinue manufacturing operations during the next 18 months to five years at three solid-dosage sites that manufacture tablets and capsules: those in Caguas, Puerto Rico; Loughbeg, Ireland; and Rouses Point, New York. Wyeth announced in 2005 that it would exit and sell the Rouses Point site. Pfizer also plans to phase out pharmaceutical solid-dosage manufacturing in Guayama, Puerto Rico, but that site will expand its consumer-healthcare operations. Reductions are planned at two other solid-dosage facilities in Illertissen, Germany, and Newbridge, Ireland.

Two aseptic facilities that make sterile injectable medicines are targeted for exit: Dublin, Ireland, and Carolina, Puerto Rico. Pfizer also plans changes to its biopharmaceutical-manufacturing network. The company plans to exit operations in Shanbally, Ireland, and Pearl River, New York. The Pearl River site, however, will remain Pfizer's Center of Excellence for vaccine R&D. Biotechnology plants in Sanford, North Carolina, Andover, Massachusetts, and Havant, United Kingdom, are expected to see reductions.

Pfizer plans to cease production of consumer-healthcare products at its plants in Richmond, Virginia and Pearl River, New York. Pfizer said that R&D jobs in both Pearl River and Richmond will be unaffected by the planned manufacturing exits. The timing of specific exits will depend upon the complexity of operations, the amount of time required for product transfers, and other business requirements, said Pfizer in a May 2010 press release. Pfizer Global Manufacturing currently operates 76 plants internationally with a workforce of approximately 30,000.

In outlining the changes to its manufacturing network, Pfizer also summarized how its transformed manufacturing network will look. Pfizer's solid-dosage network will include plants in Freiburg, Germany; Amboise, France; Vega Baja and Barceloneta, Puerto Rico; Ascoli, Italy; Newbridge, Ireland; and Illertissen, Germany. Its aseptic-manufacturing network will consist of plants in Puurs, Belgium; Perth, Australia; Catania, Italy; and Kalamazoo, Michigan. Its biotechnology-manufacturing network will consist of sites in Grange Castle, Ireland; Strangnas, Sweden; Algete, Spain; Havant, UK; Andover, Massachusetts; and Sanford, North Carolina. The consumer healthcare network will include plants in Guayama, Puerto Rico; Montreal, Canada; Albany, Georgia; Aprilia, Italy; Hsinchu, Taiwan; and Suzhou, China.

The second phase of the plant network strategy, which will fully align Pfizer’s global animal-health manufacturing and supply organization, includes the recommended exit the company’s Weesp plant in The Netherlands, along with divestitures earlier in 2010 of some products and four plants in the United States, Ireland and Australia. These changes will reduce the size of the company’s animal-health plant network by nearly 20%.

This reconfigured network will consist of plants in the following locations: Charles City, Iowa; Lincoln, Nebraska; Laurinburg, North Carolina, White Hall, Illinois; Campinas, Brazil; Suzhou, China; Hsinchu, Taiwan; Melbourne, Australia; Wellington, New Zealand; Louvain-la-Neuve, Belgium; Olot, Spain; and Haridwar, India. Pfizer also plans to invest up to $20 million to build a new veterinary medicine research and development pilot plant in Louvain-la-Neuve during the next two to three years. Four other Pfizer plants in the study will continue to manufacture products for the animal-health business: Kalamazoo, Michigan; Guarulhos, Brazil; Catania, Italy; and Nagoya, Japan.

Studies of the nutrition and emerging markets plant networks are currently underway.

Biologics and biomanufacturing
Pfizer’s biomanufacturing activities currently involve nine sites for biologic drug-substance (inclusive of microbial and cell-culture production) and drug-product manufacturing, of which three are Pfizer legacy sites, and related cold-chain activities. The biomanufacturing activities supports products with revenues of $9 billion, and 5400 people are directly involved in biomanufacturing.

The key products in Pfizer’s biologics products, representing both legacy Pfizer products and products gained in the Wyeth acquisition are: Prevnar (pneumococcal 7-valent conjugate vaccine, diphtheria CRM197 protein); Prevnar 13 (pneumococcal 13-valent conjugate vaccine, diphtheria CRM197 protein); Enbrel (etanercept); InductOS (recombinant human bone morphogenetic protein-2/absorbable collagen sponge); Somavert (pegvisomant for injection), Macugen (pegaptanib sodium injection); BeneFix (coagulation Factor IX, recombinant); Fragmin (dalteparin); Neumega (oprelvekin); rebif (interferon beta-1a); Genotropin (somatropin, [rDNA origin] for injection); Xyntha (ntihemophilic factor, recombinant, plasma/albumin-free). In June 2010, Pfizer voluntarily withdrew Mylotarg (gemtuzumab ozogamicin for injection), a biologic for treating relapsed acute myeloid leukemia.

Biomanufacturing strategy
Pfizer’s approach in biomanufacturing is part of an integrated strategy in Pfizer Global Manufacturing, which encompasses the company’s network performance framework. This framework consists of three main elements: the company’s network performance principles, balanced scorecard, and network leadership, says Louis S. Schmukler, senior vice-president of Pfizer’s Specialty and Biotechnology Operating Unit in Pfizer Global Manufacturing. For biomanufacturing specifically, Schmukler says we are “reblueprinting our biomanufacturing at Pfizer, which involves a strategy of science over stainless steel,” he says. “This involves a focus on process development and continuous improvement compared with capital investment.”

Specifically, Schmukler says Pfizer’s biomanufacturing strategy entails several key objectives: reconfiguring, consolidating, and simplifying the biomanufacturing supply chain and creating an optimized, integrated, and interdependent bio supply network. The company is also focused on increasing asset utilization and flexibility to manage product demand, enhance cost competitiveness, and leverage current and planned technology. Part of that approach entails greater flexibility. Currently, 50% of Pfizer’s biomanufacturing facilities are dedicated. After full implementation of its biomanufacturing strategy, Schmukler says that no facilities will be fully dedicated to one product.

These goals also involve using internal and external manufacturing sources as part of an integrated approach to manufacturing and product supply. The company’s external manufacturing strategy extends to both drug- substance and finished-product manufacturing and is used based on three major factors: meeting product demand variability, gaining access to specialized technology, and geographic access, including in emerging markets.

Schmukler also says the company is interested in becoming involved in biosimilars and is in the process of further defining that strategy. He says the company views three main areas: biosimilars (i.e., follow-on biologics which match the branded biologic as closely as possible) ; enhanced biosimilars (i.e., follow-on biologics with improved delivery, formulation, dosing or routes of administration); and biosuperiors, or drugs with a similar therapeutic target or mechanism of action, with structural changes and a new clinical profile that differentiates them from the original. Schmukler concludes that the company will use its internal infrastructure as well as partner with other parties in realizing its biosimilar strategy.

Listen to a podcast with Louis S. Schmukler, senior vice-president of Pfizer’s Specialty and Biotechnology Operating Unit in Pfizer Global Manufacturing, moderated by Michelle Hoffman, editor-in-chief of Pharmaceutical Technology.