Guest Editorial by Audrey Greenberg, Venture Partner and Chair, Department of Business Development, Mayo Clinic
Radiopharmaceuticals are accelerating clinically, but manufacturing infrastructure has not kept pace. Radioligand therapeutics exemplify the shift toward highly targeted therapeutics with outsized therapeutic impact, yet the sector confronts infrastructure scarcity that threatens to limit commercial potential just as clinical promise accelerates.
The constraints are specific and immediate. The industry faces three critical bottlenecks: high-specific-activity isotope supply, GMP hot-cell capacity with automated handling, and integrated CDMOs that understand both radiochemistry and biologics. Few facilities can manage both radioactive materials and biologic conjugates. The workforce is limited, the regulatory environment is complex, and these constraints create systemic friction.
For radiopharma developers entering this space in 2026, the patterns I’ve observed in cell and gene therapy over the past five years offer clear signals about what to avoid and what to accelerate.
Pattern 1: Industrial Discipline Wins Over Scientific Intuition
Those that industrialize will accelerate. Those that don’t will be left behind.
For cell and gene therapy developers, the issue is process robustness. Variability in viral vector production continues to dominate program timelines, and cost of goods remains a barrier to commercial viability. The companies making progress apply operational discipline traditionally found in automotive or semiconductor manufacturing. Standard platforms, modular unit operations, and automated analytics replace artisanal processes built around scientific intuition. Those that industrialize will accelerate. Those that don’t will be left behind.
For radiopharma, manufacturing is a choreography between physics and biology where timing is everything. Developers must secure reliable radionuclide sources early, build processes around decay-aware scheduling, and invest in QC methods that can operate within half-life constraints. Three priorities matter: isotope supply, shielding strategy, and real-time QC.
Pattern 2: Virtual Models Still Need Heavyweight CMC
Industrialization, not invention, is the defining challenge of 2026.
Virtual biotechs, once celebrated for capital efficiency, are learning that lean teams still need heavyweight CMC strategies. Across the industry, the conversation has shifted. We no longer ask whether the science works; we ask whether it can be produced consistently, at cost, and at scale. CMC must become an asset with defined option value. Every dollar should support a milestone, a regulatory path, or a manufacturability insight that preserves future flexibility.
This forces early clarity: what data truly matters, which CDMOs have the right technical adjacency, and where to avoid the temptation to overbuild. In today’s funding environment, where capital consolidation is reshaping boardroom priorities, hope is not a capacity strategy, and markets no longer price it as one. Industrialization, not invention, is the defining challenge of 2026.
Pattern 3: Capacity Has Become a Valuation Differentiator
A CDMO’s weakest link in supply or safety quickly becomes the sponsor’s bottleneck.
Capacity, historically treated as an operational detail, has emerged as a strategic differentiator in valuation. Investors now examine CDMO queues, supply-chain exposure, and the quality of contractual commitments alongside clinical data. A company with secured access to critical manufacturing steps, be it plasmid supply, vector runs, or fill-finish, enters fundraising with a materially stronger position.
For radiopharma, this applies with additional urgency given infrastructure scarcity. When evaluating radiopharma CDMOs, sponsors should assess five factors:
- Radionuclide supply chain diversity (not dependence on a single reactor model)
- Integrated radiochemistry and biologics capabilities
- Hot-cell automation maturity
- Turnaround times for short-lived isotopes
- Radiation safety culture with a documented track record
A CDMO’s weakest link in supply or safety quickly becomes the sponsor’s bottleneck.
What Radiopharma Needs Now
The biopharma industry has entered its industrial era. Those who build with that reality in mind will shape the next decade.
The opportunity is compelling. Radiopharmaceuticals exemplify the shift toward highly targeted therapeutics with outsized therapeutic impact. What the field needs now is specific investment: isotope production capacity, automation-ready hot cells, and CDMO models built from the ground up for radioligand workflows. The companies that commit to these investments (suppliers and sponsors alike) will define the competitive landscape by 2027.
As we look ahead, one theme cuts across modalities: manufacturing is no longer a back-office function. It is a strategic lever, a valuation driver, and increasingly, a core element of scientific differentiation. Whether in cell therapy, gene therapy, or radiopharma, the winners in 2026 will be those who treat manufacturing as integral to the innovation process, not a constraint to manage after the fact.
The biopharma industry has entered its industrial era. Those who build with that reality in mind will shape the next decade.
Audrey Greenberg is Venture Partner and Chair of the Department of Business Development at Mayo Clinic, where she advises portfolio companies on CMC strategy and manufacturing partnerships.
