Why the RION–Lonza Collaboration Matters to Biopharma Professionals

Alpha Tauri 3D - stock.adobe.com

Lonza and RION, a regenerative medicine company developing platelet-derived exosome therapies, announced on Sept. 23, 2025 that they will collaborate to expand production of Rion’s purified exosome product (PEP). Under the agreement, Lonza will provide current good manufacturing practice (CGMP) manufacturing and technical support for PEP drug substance at its Houston, Texas facility to enable supply for late-phase clinical trials and eventual commercialization. With Lonza’s technical support and capabilities in extracellular vesicles, RION aims to operationalize its process at scale (1).

This partnership marks a significant development in exosome-based therapeutic manufacturing, a field still navigating the transition from research-scale production to reliable, industrial-scale processes. The collaboration highlights the growing need for advanced manufacturing solutions to support new biologic modalities, such as extracellular vesicles (2).

“This collaboration with Lonza ensures that our proprietary exosome manufacturing platform can be scaled to meet clinical and future commercial demand,” said Atta Behfar, co-founder and CEO, RION, in a company press release (1). “RION’s breakthrough in exosome biomanufacturing now paired with Lonza’s global infrastructure allows us to bring this biologics-based innovation to patients rapidly and reliably, while staying true to our mission of affordable access.”

What are exosome therapeutics, and what is their role in regenerative medicine?

RION’s lead candidate, PEP, is derived from human platelets and formulated as a lyophilized powder. Designed with immunomodulatory, anti-inflammatory, and regenerative properties, PEP represents a platform technology intended for use across multiple therapeutic areas. The shelf-stable format enables flexibility in administration routes, broadening its potential application, according to the company in the release.

Ongoing clinical programs are targeting advanced tissue regeneration, dermatologic conditions, musculoskeletal and pulmonary diseases, cardiovascular health, and women’s health. This range illustrates the therapeutic promise of exosome-based approaches in areas for which current treatment options remain limited.

“We are pleased to support RION’s groundbreaking work in exosome-based therapies. Through our … capabilities in exosome development, characterization, and manufacturing, we enable our customers to progress their innovative therapies efficiently and reliably,” said Davide Zocco, commercial development head for exosomes and mRNA technologies, Specialized Modalities, at Lonza, in the release. “Through our collaboration with RION, we will apply our expertise to support the manufacture of PEP drug substance, aiming to help accelerate the availability of innovative treatments to patients worldwide.”

What does the collaboration mean for biopharmaceutical development and manufacturing?

The collaboration underscores the increasing role of contract development and manufacturing organizations in supporting novel therapeutic modalities. Exosomes, while promising, present manufacturing challenges distinct from traditional biologics. Scaling processes that preserve biological function, ensure product consistency, and meet regulatory standards is a critical hurdle in bringing these therapies to market (2).

By combining RION’s proprietary platform with Lonza’s established infrastructure and expertise in extracellular vesicles, the companies aim to establish a pathway toward consistent, scalable production. This model reflects how partnerships between innovators and experienced manufacturers can help overcome translational bottlenecks.

For biomanufacturing and biopharma drug development, the RION–Lonza collaboration represents an instructive example of how specialized platforms are being integrated into global production networks. As exosome therapies move closer to commercialization, the success of such partnerships will help define how regenerative medicines are manufactured and delivered at scale.

References

1. Lonza. RION Engages Lonza to Scale Manufacturing Exosome Based Therapeutics. Press Release. Sept. 23, 2025.
2. Chen, H.; Li, Q. Recent Advances in Scalable Exosome Production: Challenges and Innovations. Chin. J. Plast. Reconstr. Surg. 2025, 7 (3), 149–163. DOI: 10.1016/j.cjprs.2025.05.001