Why US Pharma Manufacturing Delivers Strategic Value
Determining where to manufacturing a drug product is a critical part of ensuring a strong supply in today’s pharma and biotech landscape. Pharma leaders have been increasing their focus on US-based manufacturing options in order to strengthen supply chains, support regulatory compliance, and minimizing the potential for drug shortages.
Investing in US manufacturing partnerships for biologics and other critical drug products unlocks the growing number of benefits of domestic production while accelerating speed to market. The strategic value of US manufacturing becomes especially clear when viewed through the lens of supply chain risk and supply continuity.
Reduced Supply Risk Through US Pharma Manufacturing
Supply chain resilience is the foundation for realizing the full range of benefits that domestic manufacturing offers. With geopolitical uncertainties and shifting trade relationships impacting global supply networks, a proven strategy for mitigating supply chain risk is to establish domestic manufacturing capacity to reach US patients.
Manufacturing drug products in the United States can help reduce transportation complexity, improve supply chain visibility, and mitigate risks associated with geopolitical disruptions, trade policy changes, and international shipping delays. For therapies serving US patients, domestic production places critical manufacturing operations closer to the market they support, helping sponsors build more resilient supply chains.
At a national level, improving supply chain resilience is also essential for biosecurity efforts and supporting the US response to public health emergencies. Continued funding for programs like the BioMaP-Consortium demonstrates the US government’s investment private-public partnerships to bolster national capacity for essential medications. To realize the full benefit of increased domestic capacity, manufacturers must be able to successfully navigate US regulatory pathways.
Established US Regulatory Expertise Accelerates Speed to Market
When securing domestic capacity, working with a partner who has an strong history of US regulatory experience can help streamline the approval process. From FDA filings to sterile manufacturing compliance under EU Annex 1, an experienced manufacturing partner can help navigate regulatory and quality requirements while minimizing potential delays and execution risks.
Access to Advanced Manufacturing Infrastructure
Beyond supply chain and regulatory advantages, US-based manufacturing partners offer access to advanced infrastructure that can accelerate commercialization. Leading sites continue to invest in technology like isolators, automation, and single-use systems to increase production speed for complex therapeutics while maintaining sterility at scale.
Many manufacturers also benefit from established operational frameworks and logistics capabilities. Legal frameworks like Foreign Trade Zones (FTZs) further enhance the appeal of US manufacturing by offering logistical flexibility and the potential to reduce costs associated with trade. At JHS, our partners have found that our FTZ can save them time and money when importing foreign drug substances converted to final drug products in our facility intended for US markets.
A Growing Ecosystem of Biomanufacturing Talent
The US is also investing in the workforce needed to support continued growth across the biopharmaceutical industry. Dozens of academic institutions around the country are launching certification programs to train students for biomanufacturing careers. Having a skilled, experienced workforce practiced in GMP and aseptic principles available is critical to delivering high-quality batches on time at scale. In response to this need, JHS and Spokane Colleges (Community Colleges of Spokane) have partnered to create a certification program that helps fill the talent pipeline by teaching the fundamentals of biomanufacturing and aseptic techniques.
Partnering with JHS to Unlock the Full Value of US Pharma Manufacturing
Building new domestic manufacturing capacity can require significant time and capital investment. Working with an established CDMO like Jubilant HollisterStier (JHS) provides access to the benefits of US manufacturing and reduces speed to market by leveraging existing infrastructure and relationships. When you partner with us, you get immediate access to a state-of-the-art GMP facility built for biologics production at scale.
With available capacity, proven regulatory expertise, and advanced sterile manufacturing infrastructure, we help our partners strengthen their US supply chains while accelerating the path to commercialization. Let’s start a conversation about how we can help you leverage the benefits of US manufacturing by sending us a message at: https://www.jublhs.com/contact/
