Bringing Manufacturing Back Home: The Road to Reshoring
In times of supply chain volatility and with threats of potential tariff increases on imported drugs, active pharmaceutical ingredients (APIs), and other items, manufacturers are rethinking their dependence on overseas production and sourcing. Many major companies have already begun the process of “reshoring” or “onshoring” by accelerating investments in manufacturing facilities in the U.S. and diversifying their supply chains.
Among them are Thermo Fisher Scientific, which pledged to invest $2 billion in U.S. manufacturing operations and R&D acceleration over the next four years; Merck, which recently began construction of a $1 billion biologics center of excellence in Delaware; and AbbVie, which announced a $195 million investment in expanding API manufacturing in Illinois.
Federal Support
The U.S. Food & Drug Administration (FDA) are also bolstering the effort to strengthen the domestic pharmaceutical supply chain by helping streamline the review and regulatory approval process for building new manufacturing sites in the U.S. through their new FDA PreCheck Program.
The creation of this program comes as no surprise since the federal government has been investing billions of dollars in pharmacy and drug manufacturing since the early 2010s, starting with the Obama administration, according to Healthcare Dive. They and subsequent administrations have been aiming to curb prescription drug shortages and advance the U.S. manufacturing economy. During the COVID-19 pandemic—when overseas supply chains and API deliveries were disrupted—the need to bring production back home became even more apparent and pressing.
Navigating Challenges
Despite demand, the prospect of relocating entire factories and workflows halfway around the world is a huge endeavor. Reshoring not only requires building or moving into a new facility, it also requires the space to be set up and the equipment and systems to be qualified and verified. New procedures that meet strict safety and regulatory requirements must also be established so products produced in the facility will meet quality standards.
“When you think about opening a new manufacturing facility, it’s critical that you do it within the confines of GxP (Good x Practices) and FDA regulations,” said Dwai Smith, strategic key accounts director, pharma for the Fisher Scientific channel at Thermo Fisher Scientific. “It’s going to go through various validation audits throughout the process, starting with the initial buildout itself all the way through the infrastructure, furnishing, and lab design.”
The time it takes to establish a fully validated facility and cost factors can also pose challenges, Smith added. Starting up a new pharmaceutical manufacturing facility in the U.S. can cost up to $2 billion and take 5 to 10 years before it’s operational, according to Pharmaceutical Research and Manufacturers of America.
How We Can Help
With expert assistance, however, these are all challenges that are possible to navigate. The Fisher Scientific channel offers end-to-end services that can seamlessly take companies’ reshoring and onshoring projects from concept to completion. Our team of experienced colleagues understands the importance of establishing innovative, compliant, and scalable facilities on time and on budget.
From the pre-planning and design stage to startup and evaluation, you can partner with us to get help with preparing budgets, timelines, facility plans, and elevation drawings, soliciting proposals, obtaining IQ, OQ, and PQ validation, and more. When you’re at the operational readiness stage, we can help you procure furniture, storage units, chemicals, gowning apparel, personal protective equipment, and whatever else you need to get your operation up and running. Our strengths are listening and aligning, enabling us to deliver innovative, customized solutions shaped by your priorities.
“Across the entire Thermo Fisher Scientific organization, we have the broadest product and service portfolio to support the finished product from end to end,” said Smith. “From process development all the way through manufacturing, we can support the entire workflow.”
Strengthening Your Supply Chain
Through inevitable market shifts, we can provide supply chain assurance to help maintain your business continuity. Our purpose-built warehouse and global distribution network are designed around the safe handling, storage, and transportation of products and materials—delivering the supply security to simplify procurement, mitigate risk, and support your cGLP and cGMP requirements.
“We have the advantage of being able to source raw materials from different parts of the world,” said Smith, “so in the event of a supply constraint, or heaven forbid, a disaster at a particular distribution site, there is no impact to business.”
Whether you’re an owner, architect, engineer, or contractor building a pilot or scale-up facility, partnering with the Fisher Scientific channel offers unparalleled advantages. Get in touch with our experts to find out how we can help with your planning, procurement, buildout, and beyond. Visit fishersci.com/new-facility-support to learn more.
Gina Wynn is a Thermo Fisher Scientific staff writer.