When Lonza announced its partnership with RION in September 2025 to manufacture platelet-derived exosome therapeutics, the collaboration signaled growing CDMO investment in specialized modalities. As exosome-based therapies advance from academic research toward commercial reality, manufacturing scale-up presents distinct technical and strategic challenges.
Davide Zocco, Commercial Development Head for Exosomes and mRNA Technologies at Lonza, a global CDMO, shares insights on how his team approaches exosome manufacturing partnerships, what differentiates successful programs, and where developers should focus their efforts when preparing for CDMO engagement.
The Technical Foundation: Why Exosome Manufacturing Differs
Exosome therapeutics bring distinct manufacturing challenges compared to traditional biologics. The complexity begins with source material and extends through every production step.
“Exosomes are complex biological entities with inherent variability,” Zocco explains. “Manufacturing success depends on robust process controls, comprehensive analytical characterization, and a deep understanding of the biology.”
This complexity shaped Lonza’s buildout of specialized capabilities at its Houston facility, where the company manufactures RION’s Purified Exosome Product™ (PEP™). The platform nature of exosome therapeutics (where a single manufacturing process can potentially address multiple indications) creates both opportunity and technical challenges.
RION’s program spans seven therapeutic areas, including diabetic foot ulcers, musculoskeletal disease, and cardiovascular applications. This breadth required Lonza to establish manufacturing processes capable of supporting diverse clinical development timelines and regulatory pathways.
Analytical Development
When asked about the primary technical challenges in exosome manufacturing, Zocco points to characterization and analytics.
“The biggest challenge is developing robust analytical methods that can adequately characterize these complex biological products,” he states. “The field is still evolving in terms of standardized approaches to identity, purity, potency, and stability testing.”
This analytical uncertainty creates risk for both developers and CDMOs. Unlike monoclonal antibodies or gene therapies, where characterization methods are well-established, exosome programs often require custom analytical development alongside process scale-up.
Key analytical considerations include:
- Particle characterization and size distribution
- Surface marker profiling
- Cargo content analysis
- Biological activity and potency assays
- Stability under various storage conditions
“We work closely with our partners to develop fit-for-purpose analytical packages that meet regulatory expectations while remaining practical for routine manufacturing,” Zocco notes.
This collaborative approach proved essential for the RION partnership, where the company’s lyophilized formulation strategy required specific stability testing protocols.
CDMO Selection
For biotechs evaluating CDMO partners for exosome programs, Zocco recommends looking past conventional manufacturing capacity metrics.
“Developers should evaluate a CDMO’s specific experience with extracellular vesicles, their analytical capabilities, and their track record of supporting regulatory filings for novel modalities,” he advises.
The specialized nature of exosome manufacturing means not all biologics CDMOs possess relevant expertise. Equipment requirements, cleanroom classifications, and quality systems differ from standard recombinant protein production.
Lonza’s investment in exosome-specific infrastructure at Houston positions the facility to support multiple programs simultaneously. However, Zocco emphasizes that technical capabilities alone don’t guarantee partnership success.
“Cultural fit and communication are critical,” he explains. “Exosome programs often require close collaboration between CDMO and sponsor teams to troubleshoot challenges and optimize processes. The relationship needs to support that level of interaction.”
Process Development Strategy
One common pitfall Zocco identifies is inadequate planning for commercial-scale requirements during early process development.
“Many developers optimize their process at a small scale without considering how it will translate to larger volumes,” he observes. “This can necessitate significant process changes later, which adds risk and delays timelines.”
His recommendation: engage CDMO partners early to ensure process design aligns with commercial manufacturing capabilities.
For RION, this meant evaluating how their proprietary biomanufacturing platform, developed at Mayo Clinic over two decades, would perform in Lonza’s equipment and facility configuration. The tech transfer process required careful documentation of critical process parameters and quality attributes.
“Successful tech transfer depends on comprehensive knowledge transfer from the developer,” Zocco notes. “The more we understand about why certain process steps matter, the better we can maintain product quality during scale-up.”
Looking Forward: The Exosome Manufacturing Ecosystem
As more exosome therapeutics advance through clinical development, Zocco anticipates continued maturation of manufacturing capabilities across the CDMO landscape.
“We’re seeing increasing investment in specialized infrastructure and expertise,” he observes. “This benefits developers by providing more options and driving innovation in manufacturing approaches.”
Lonza’s commitment to the exosome space extends beyond individual partnerships. The company continues developing new analytical methods, optimizing purification technologies, and expanding capacity to support growing demand.
“Exosomes represent an important frontier in biologics,” Zocco concludes. “Success requires CDMOs that combine technical expertise with operational excellence—and partnerships where both parties are committed to advancing the field.”
