Six Specialized Modalities Testing CDMO Readiness In 2026

By Jeffrey S. Buguliskis, PhD, Deputy Chief Editor, Outsourced Pharma

Picture a neighborhood tailor who has spent years turning out reliable suits and dress shirts. Then, all of a sudden, the order book changes. One client needs a fireproof racing suit. Another needs a ballet costume that can survive nightly performances. A third wants a deep-sea drysuit repaired by Friday. It is still sewing, technically. But the tools, materials, testing, and workflow are suddenly everything.

That's roughly where drug manufacturing is right now.

Biopharma pipelines are filling with specialized modalities that do not fit legacy manufacturing assumptions. For sponsors, the problem is no longer just finding a CDMO with open capacity. It is finding one with the exact technical setup, operating discipline, and logistics model required for a very specific product. In several categories, demand is outpacing specialized supply. Here are six chokepoints where sponsor-side diligence matters most.

1. Radiopharmaceuticals

The momentum behind targeted alpha and beta-therapies is real, but the manufacturing infrastructure hasn't kept pace. Fabricating them requires a rare combination of radioactive materials handling and sterile drug product execution.

Many traditional CDMOs lack shielded hot cells, isotope-handling licenses, and teams trained to operate under both nuclear and aseptic requirements. Some can support parts of the workflow, but not the entire chain.

The central constraint is time. Short isotope half-lives compress production, release, and shipping into a narrow window, so geography and operational sequencing become as important as technical capability.

What sponsors should ask now?

• Where does isotope receipt occur, and how fast is handoff to manufacturing?
• What is the normal release-to-ship timeline, not the best-case one?
• Which steps are internal and which are subcontracted?

2. Antibody-Drug Conjugates (ADCs): Coordination Is The Bottleneck

ADCs require alignment across monoclonal antibody production, linker and payload chemistry, conjugation, and analytics. That sounds manageable on a slide. It is harder in operations.

The sharpest constraint often sits around payload handling and conjugation. Highly potent payloads may require Occupational Exposure Band (OEB) 5 or 6 containment, specialized facility design, and experienced personnel that many otherwise capable providers lack.

Sponsors can assemble a workable multi-CDMO network, but each transfer adds documentation burden, scheduling risk, and more opportunities for drift. In practice, the chokepoint is often coordination across interfaces, not one isolated unit operation.

What sponsors should ask now?

• Which steps are truly co-located versus centrally managed across sites?
• What are the current lead times for high-potency conjugation suites?
• How are deviations investigated when multiple sites are involved?

3. Microbiome-Derived Therapies: The Anaerobic Reality Check

Live Biotherapeutic Products (LBPs) push manufacturing into a very different operating model. Producing living bacterial therapies, especially obligate anaerobes, is not a simple extension of standard microbial fermentation.

Many candidates cannot tolerate exposure to oxygen. That means process design, transfers, and downstream handling must be built around oxygen control from the start, not patched in later.

There is also a segregation challenge. Cross-contamination is a genuine concern when live microbial products share space with other biologics, not a theoretical one. That concern can force the creation of dedicated suites or facilities, which remain limited.

What sponsors should ask now?

• Is anaerobic control designed into the process, or handled as a workaround?
• What segregation policies apply to live microbial programs?
• Has the site demonstrated scale runs beyond pilot batches?

As supply chains fragment across specialized steps, the highest-risk point is often the interface. Oversight and coordination can matter as much as the unit operation.

4. Targeted Protein Degraders (TPDs): Chemistry That Fights Back

TPDs, including Proteolysis Targeting Chimeras (PROTACs) and molecular glues, have strong scientific momentum. Their manufacturing challenge is less about hype and more about chemistry.

These molecules can exhibit poor solubility, instability, and purification difficulties, as well as multi-step synthesis routes and low yields. Routes that appear clean at bench scale often fail during CMC scale-up.

The sponsor-side mistake is assuming that any strong small-molecule CDMO can absorb the complexity without a learning curve. Some can. Some cannot. The difference often lies in the depth of process chemistry and analytical problem-solving, not in headline capacity.

What sponsors should ask now?

• Which other high-complexity molecules has the team successfully scaled?
• Where do yields or purifications typically break down in comparable routes?
• How early does analytical development engage with manufacturing?

5. Non-Viral Delivery And Precision Lipid Nanoparticles (LNPs)

The first wave of messenger ribonucleic acid (mRNA) manufacturing built meaningful LNP capacity, but much of it was designed for high-volume vaccine production. Many next-generation mRNA therapeutics need something else.

Oncology, rare disease, and gene editing programs often require smaller batches, tighter control of lipid ratios, and particle characteristics tuned for tissue-specific delivery. The value shifts from throughput to formulation precision and reproducibility.

The question isn't whether a CDMO can make LNPs. It's whether they can make the right ones for your program.

What sponsors should ask now?

• Is the platform optimized for volume or small-batch precision?
• Which critical quality attributes are measured in-process versus after the run?
• How much formulation and method development still sits ahead of tech transfer?

6. Exosomes: Downstream Processing Comes First

Exosomes, also known as extracellular vesicles (EVs), are attracting interest as natural delivery systems. The manufacturing bottleneck, however, is still heavily concentrated in downstream processing.

Separating and concentrating vesicles from cell culture material without damaging structure or function is difficult. Filtration, chromatography, and characterization all carry more weight, and small process changes can affect biological activity.

There is also a standardization gap. The field still lacks a broad consensus on scalable purification and characterization approaches, making CDMO selection harder and comparability across runs more difficult.

What sponsors should ask now?

• What exosome-specific downstream processes has the site run, and at what scale?
• How is vesicle integrity assessed after purification?
• What process changes are expected between early and later-stage supply?

What Sponsors Should Do Next

Right now, the edge isn't finding the biggest CDMO…it's qualifying the most relevant one before your competitors do. In these six segments, technical fit beats broad platform marketing.

Map the constraint before you sign. Is it containment, purification, analytical characterization, release timing, or logistics proximity? Once that’s clear, the right questions come more quickly, and poor fits show up earlier.

A lack of thread doesn't cause most delays. They happen when a team takes on a specialty job with the wrong needles and the wrong sequence on the workbench. The demand is there. The craftsmanship is often what's scarce.