Why Reshoring Small Batch Pharma Production is Critical for Biotechs

For biotech companies developing novel therapies, securing a reliable supply chain for manufacturing clinical trial materials and eventual commercial drug products is essential. However, many biotechs have relied heavily on outsourcing pharmaceutical manufacturing overseas, particularly for small batch sizes needed during clinical development. This offshoring strategy has created vulnerabilities that drive a renewed focus on reshoring pharma production back to the United States.

The COVID-19 pandemic laid bare the risks of having such a concentrated pharmaceutical supply chain overseas. International shutdowns and transport restrictions caused widespread disruptions when the global health crisis erupted. The U.S. faced shortages of critical drugs, vaccines, and medical supplies without adequate domestic manufacturing capacity. The pandemic exposed the potential for drug shortages and quality issues when relying too heavily on foreign suppliers during a health emergency.

Potential Impact of the BIOSECURE Act

A new challenge adding urgency to reshoring is the proposed BIOSECURE Act being considered by the U.S. Congress. This bipartisan legislation could limit the ability of American life sciences companies to contract with biotechnology firms tied to “foreign adversary” nations like China. The act would prohibit the U.S. government from contracting with designated “biotechnology companies of concern” and prevent companies receiving federal funding from working with these firms.

Depending on the final scope, the BIOSECURE Act could force biotechs to choose between forgoing relationships with some of the industry’s largest firms or forgoing relationships with the federal government. With strong bipartisan backing, some form of this supply chain-focused legislation is expected to become law in 2024.

While large-scale commercial manufacturing may still utilize some offshore capacity, biotechs should prioritize reshoring for small batches during clinical development and launch phases. The potential impacts of the BIOSECURE Act make domestic small-batch manufacturing capabilities even more vital to reducing operational risks. Companies pioneering new therapeutic modalities must maintain tight control and oversight of these critical operations within the U.S.

Reasons to Prioritize US-Based Biologics Manufacturing

Beyond pandemic-related disruptions and the BIOSECURE Act, there are broader strategic reasons why biotechs should prioritize reshoring pharmaceutical manufacturing. Reducing significant supply chain vulnerabilities by reshoring domestic small-batch manufacturing provides biotechs with resilience, quality control, IP protection, and greater agility. Maintaining this critical capacity and oversight within the U.S. is vital for companies pioneering new therapeutic modalities.

Quality Control
Strict quality control and oversight are paramount when producing complex biologic therapies. Manufacturing drug substances and products domestically enables much tighter supply chain control and the ability to manage quality properly. When production occurs closer to the biotech’s scientists and quality teams, there are fewer risks of quality issues, contamination, or mishandling.

Smaller firms are now driving a significant portion of biotech innovation. These firms often work on cutting-edge biologics and advanced therapies that are highly complex. The novelty and intricacy of these products necessitate a very hands-on, meticulous approach from the development and manufacturing teams to ensure product safety, purity, and efficacy are maintained throughout the production lifecycle. Having manufacturing operations nearby allows scientists, engineers, and quality experts to have direct oversight and control over every critical process step.

IP Protection
Protecting valuable intellectual property is a constant concern for companies developing cutting-edge therapies. Keeping technical processes and know-how onshore can better safeguard against IP theft or leakage of proprietary manufacturing techniques, formulations, and trade secrets to foreign competitors.

Additionally, regional manufacturing can simplify compliance with local laws and regulations regarding intellectual property protection, which may vary across jurisdictions. Keeping operations within a single regulatory framework can streamline efforts to secure and enforce IP rights.

Faster Speed & Agility
Rather than dealing with long transoceanic shipping lanes, utilizing regional manufacturing provides faster speed and agility to shift resources and respond to changing clinical needs and commercial demands. This ability to be nimble is a crucial advantage for biotechs, allowing them to capitalize on market opportunities more quickly by rapidly adjusting production to meet fluctuating demand.

Localization also enables biotechs to swiftly adapt manufacturing processes and product formulations in response to evolving clinical data or patient needs. Furthermore, proximity to target markets and clinical sites facilitates better communication and collaboration, enabling biotechs to customize or personalize products based on local requirements.

Regulatory Advantages
Regional manufacturing mitigates supply chain risks associated with global distribution, such as weather disruptions, port congestion, and geopolitical tensions, while reducing lead times for delivering products to customers, healthcare providers, and clinical trial sites. It also optimizes inventory management by producing closer to the point of demand, minimizing excessive stock and product expiration risks.

Perhaps most importantly, U.S. and European drug authorities have particularly robust regulatory regimes. Manufacturing in well-regulated Western markets can provide necessary harmonization and simplify regulatory compliance compared to CDMOs in regions with varying quality standards.

Establishing Domestic Manufacturing Capabilities

There are compelling strategic reasons why biotech companies developing novel therapies should prioritize reshoring small-batch pharmaceutical manufacturing back to the United States. The COVID-19 pandemic exposed the vulnerabilities of relying too heavily on an overseas supply chain, leading to potential drug shortages during a health crisis. Beyond pandemic issues, reshoring provides biotechs with greater quality control, intellectual property protection, faster speed and agility, and regulatory advantages compared to offshoring production.

With proposed legislation like the BIOSECURE Act potentially limiting the ability to work with firms tied to “foreign adversary” nations, the urgency to reshore is increasing. Biotechs may soon be forced to choose between forgoing relationships with some large pharmaceutical companies or the federal government if they continue using overseas suppliers of concern.

While large-scale commercial manufacturing may still utilize some offshore capacity, it is becoming vital for biotechs to establish reliable domestic small-batch manufacturing capabilities for clinical trials and product launches within the United States. Maintaining tight control and oversight over these critical operations will provide resilience and reduce operational risks as companies pioneer new therapeutic modalities. Reshoring pharma production represents a strategic imperative for the biotech industry’s supply chain.

American Small-Batch Biomanufacturing with Wheeler Bio

Wheeler Bio is proud to offer a wide range of preclinical services and CGMP clinical manufacturing from state-of-the-art facilities in Boston, MA, and Oklahoma City, OK. Leveraging our innovative Portable CMC® platform, we are uniquely equipped to support innovators in bringing therapeutics from concept to clinic with unmatched speed and efficiency through modular, cost-effective work packages tailored to your antibody or antibody-like program’s needs.

Portable CMC® is an innovative, open-source tech stack that streamlines the preclinical and clinical development of antibody therapeutics. Designed to empower innovators, this cutting-edge platform reduces the risks and costs of bringing novel antibody treatments from discovery to the clinic. This well-characterized, QbD-based drug substance manufacturing and testing platform offers a flexible and streamlined approach to process and analytical development tailored to each program’s milestones, budget, and fundraising timelines.

Reach out to discover how Wheeler Bio can support your next biotech program. Contact us.