The ADC Capacity Race Is Moving Onshore: What Innovators Should Do Now

The U.S. biomanufacturing landscape is shifting—and antibody-drug conjugates (ADCs) are at the center of the movement.

With Simtra BioPharma’s recent acquisition of a 65-acre site in Bloomington, Indiana, the company is set to become the first CDMO to offer commercial-scale ADC drug product manufacturing in the U.S. This move isn’t just a real estate story—it’s a milestone in the broader trend of reshoring high-value biomanufacturing capacity. For innovators navigating clinical or commercial-scale ADC development, the implications are immediate and strategic.

Let’s break down what this means—and what sponsors should do next.

Why ADC Manufacturing Is Going Domestic

Historically, ADC manufacturing—especially fill/finish operations—has largely taken place outside the U.S., requiring long-distance tech transfers, complex cold chain logistics, and regulatory coordination across borders. But that model is losing favor. The reasons are clear:

• Rising geopolitical risks
• Increasing demand for supply chain security
• The need for faster, more agile tech transfers
• Policy tailwinds from U.S. industrial strategy

As more CDMOs establish or expand domestic capacity, including for HPAPI containment and sterile fill/finish, the playing field is changing. Simtra is just the beginning. Others are sure to follow.

What Sponsors Need to Think About Now

This reshoring trend introduces both opportunity and pressure for drug developers. Here are three areas that require immediate attention:

1. Slot Scarcity Will Be Real

With very few facilities capable of handling commercial-scale ADCs domestically, early capacity planning is essential.Even with new builds in motion, lead times will be long. Sponsors should:

• Begin discussions well in advance of PPQ
• Prioritize flexible slot arrangements or reserved capacity
• Watch for signals of construction delays or phased facility rollouts

2. Containment and CMC Readiness Must Be Tight

HPAPIs present serious technical and regulatory hurdles. CDMOs are stepping up with high-containment suites and improved environmental controls—but sponsors need to be equally prepared. That means:

• Finalizing CMC documentation early
• Aligning process transfer protocols with U.S. regulatory expectations
• Ensuring analytical methods are validated and transferable

3. Tech Transfer Speed Is Now a Competitive Advantage

As timelines compress, the ability to shift from early-stage manufacturing to commercial readiness smoothly can be a dealmaker. Localizing manufacturing not only removes transit risk, but also shortens time-to-validation, provided sponsors and CDMOs are aligned on expectations from Day 1.

A Smarter Way to Partner

In this new environment, partnering strategy needs to evolve. Sponsors should consider:

• Dual-sourcing strategies: Splitting drug substance and drug product between global and domestic partners to manage risk
• Negotiating flexible capacity options: Including surge manufacturing, modular timelines, or co-investment models
• Clarifying PPQ/validation expectations early: And building them into the CDMO selection process

CDMOs, meanwhile, must position themselves not just as manufacturers, but as strategic allies with process development expertise, regulatory fluency, and the agility to absorb pivots in sponsor strategy.

What’s Next: The 12–24 Month Outlook

As Big Pharma pours more capital into U.S.-based infrastructure, the balance of global capacity will begin to tilt. That shift may lead to:

• A short-term tightening of U.S. CDMO availability, driving up prices for specialized services
• Increased investment in mid-sized CDMOs who can scale quickly to meet demand
• A premium on speed, containment expertise, and tech transfer fluency

For sponsors in the ADC space, this is a now-or-never moment to secure domestic partners, rework outsourcing models, and plan for long-term agility in supply chain design.

Final Thoughts

The ADC capacity race is no longer theoretical. It’s unfolding now—and it’s moving closer to home. For sponsors, proactive planning, smart partnerships, and strategic agility will define who wins in this new U.S.-centric manufacturing era.

If you're working on an ADC asset, the question isn't if you need domestic fill/finish. It's when you'll need it—and who can deliver it in time.