May 21, 2025
Antibody-drug conjugates (ADCs) are transforming oncology drug development. These next-generation therapies combine the targeting power of monoclonal antibodies with potent cytotoxic drugs, delivering treatment directly to cancer cells while minimizing harm to healthy tissue. With strong clinical data, multiple recent FDA approvals, and increasing investor interest, ADCs are one of the fastest-growing areas in biotech.
Major pharmaceutical companies—including Daiichi Sankyo, Seagen, and ImmunoGen—have made significant strides in ADC development, leading to landmark licensing deals and acquisitions.
ADCs: High Potential, High Complexity
Despite their clinical promise, ADCs are among the most challenging biologics to manufacture. The process involves multiple highly technical steps, including antibody production, cytotoxic payload synthesis, chemical conjugation, purification, and sterile fill-finish. Each stage requires tight control, specialized equipment, and often high-containment facilities due to the toxicity of the payload.
Most biotech companies lack the internal infrastructure to handle this complexity, especially at scale. As a result, the majority of ADC developers now outsource manufacturing to contract development and manufacturing organizations (CDMOs). This trend is not only practical—it’s essential. CDMOs offer established infrastructure, deep technical expertise, and regulatory-ready platforms that help accelerate timelines while maintaining compliance.
According to Pharmaceutical Technology, around 70–80% of ADC developers rely on CDMOs for at least part of their production. These partnerships allow developers to focus on their clinical and commercialization strategies while entrusting complex operations to experienced specialists.
Why Supply Chain Diversification Is a Strategic Imperative
In today’s volatile global environment, supply chain resilience has become just as important as scientific innovation. ADCs depend on a limited set of critical materials—particularly linker-payloads, which are often manufactured in specific regions like China or India. This concentration of supply poses serious risks.
Recent geopolitical tensions and regulatory shifts, such as the proposed U.S. Biosecure Act, have prompted companies to rethink their global sourcing strategies. The risk of production halts due to export controls, political instability, or shipping delays is simply too high for programs operating on tight clinical or commercial timelines (Wall Street Journal).
To manage these risks, developers are now prioritizing supply chain diversification—engaging multiple suppliers across geographies, qualifying backup CDMOs, and strengthening logistics strategies to ensure continuity. A proactive approach to supply chain planning is no longer optional; it’s a strategic requirement for ADC success.
How Pharmefex Supports ADC Development and Manufacturing Resilience
At Pharmefex, we help biotech and pharmaceutical companies navigate the unique challenges of ADC development. Our team has extensive expertise in regulatory affairs, CMC strategy, and complex manufacturing workflows. We support clients across the full development lifecycle—from early planning to commercial readiness—with a focus on reducing risk and maintaining momentum.
We work closely with clients to identify and manage CDMO partnerships, ensuring alignment on technical capabilities, quality systems, and scalability. Our supply chain experts assess geographic and operational risk, develop diversification plans, and support raw material sourcing strategies to ensure continuity across every step of production. Whether you’re procuring high-potency cytotoxins, planning global logistics, or preparing for tech transfer, we help you stay ahead of risk and on track for success.
Looking to advance your ADC program with confidence? Pharmefex provides end-to-end support for outsourcing strategy, supply chain management, and regulatory compliance. Contact us to learn how we can help build a more resilient and efficient path to market.