In its decades in the active pharmaceutical ingredients (API), New Chemical Entity (NCE) and specialty chemicals development businesses, PCI Synthesis, under the leadership of co-founder Ed Price, became recognized in the industry as the “gold standard” for CDMO services. With its relentless focus on quality, efficiency, timely delivery and transparency, a host of appreciative PCI Synthesis’ customers nominated the company for awards, which the company handily won year after year. Since 2014, PCI Synthesis won 30 CMO Leadership awards in all of the six major categories:
Industry consolidation trends and a stellar reputation brought PCI Synthesis, with two sites in Massachusetts, to the attention of acquirers, and in late 2018 the company became a business unit of Seqens, a world leader in pharmaceutical synthesis and specialty ingredients with 24 production sites and R&D centers in Europe, North America, and Asia.
Integration of the companies and their divisions continues to bear fruit for clients across the globe. Now known as Seqens CDMO North America, long-time employees are taking advantage of such added capabilities as biotage and an innovative HPAPI unit for the production of highly active ingredients at its Villeneuve-La-Garenne site while France taps U.S. expertise in earlier stage API and NCE development.
The new HPAPI site, which opened in August in the presence of Emmanuel Macron, President of the French Republic, and Bruno Lemaire, Minister of Economy, Finance and Recovery, represents a $35 million (30 million euros) investment in one of the three leading technologies in pharmaceutical synthesis, demonstrating the company’s ability to design, develop and industrialize the most complex molecules while maintaining a high level of performance in terms of quality, safety and respect for the environment.
Long before the COVID-19 pandemic, the pharmaceutical industry, which had become reliant on China, and secondarily India for raw materials and APIs, was aware of its vulnerability to supply chain disruption. As the coronavirus took hold this year, the inability to source everything from high quality reagents to masks in sufficient quantities made it abundantly clear that change was needed, and quickly. Western countries—primarily in North America and Europe—determined that to protect their businesses and the health of their citizens, it was imperative for them to take control of the supply chain.
According to the U.S. Council of Foreign Affairs, 80 percent of the APIs used to make drugs in the United States are said to come from China, India and other countries, although that number has been disputed. Members of Congress, and also the European Fine Chemicals Group (EFCG), an association representing API manufacturers, called for measures to support the repatriation of pharmaceutical chemical production from China back to Europe and the U.S.
Here’s the problem. A recent Wall Street Journal article reported that India, which supplies more than 40 percent of generics in the U.S., relies on China for the products’ ingredients—its raw materials
Further, China accounts for 68 percent of India’s imports of APIs, according to Goldman Sachs, and close to 100 percent of raw materials for certain drugs. This overdependence became problematic earlier this year when many Chinese drug factories were closed due to the COVID-19 pandemic, and the pandemic wasn’t the first time Chinese factories closed. Last year, they closed suddenly and unexpectedly, with no warning, due to pollution concerns, leaving CDMOs worldwide to scramble for new raw materials suppliers. Not only did prices increase, but India had to temporarily restrict exports of dozens of ingredients and the drugs that use them, including some common antibiotics.
There’s another issue: the FDA was inspecting only one in five foreign pharmaceutical suppliers, and likely even fewer this year due to the pandemic, creating safety concerns. Due to perceived and published quality issues with these overseas suppliers, many pharma companies want to purchase necessary supplies from Western countries, preferring entities that are regularly inspected, that they can easily visit, and that they can work with closely on technologically advanced programs, despite somewhat increased cost.
Governments in Europe and the U.S., to protect the health of their citizens, are also seeking supplier redundancy, a fast-growing trend. To help assuage these concerns about availability and quality, Seqens business units have jumped in, working together to develop the raw materials that for many years have been sourced from China for the pharmaceutical, cosmetic, food and electronics industries.
Although APIs remain the major focus, under the leadership of Jean-Noel David, its new Managing Director for North America, Seqens CDMO North America will not only make the unit responsive to the growing number of companies in the U.S., Europe and Canada seeking supply chain alternatives, but will also beef up its manufacturing of drug substances, nutraceuticals and other products.
Having lived on five continents, fluent in four languages, and with deep management experience from his years at Patheon, Thermo-Fisher and as a consultant, David is well positioned to transform Seqens CDMO North America into an international API manufacturing and development hub, leveraging PCI Synthesis’ solid reputation as the gold standard for responsiveness, quality and efficiency.