29 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2026 Drug developers can collaborate with strategic partners, such as CDMOs, who maintain knowledge of the latest regulatory guidance and apply diverse expertise to commercialize exosome therapies. This helps ensure these investigational candidates are advanced through the clinical pipeline minimizing the risk of delays. Exosomes are inherently complex. How does Lonza ensure robust characterization and quality control throughout the manufacturing process, given the variability associated with these vesicles? What specific analytical techniques are proving most effective in ensuring product consistency and safety? Exosomes are much more complex and heterogeneous compared to antibodies or small molecules. They carry a plethora of macromolecules such as proteins, nucleic acids, and lipids, and their molecular content varies depending on the cell source. Consequently, characterization and control are essential steps in exosome manufacturing to ensure a reproducible, high-quality product. At Lonza, we provide a broad range of extracellular vesicle (EV) characterization and development services, as well as GMP manufacturing services, for adherent and non-adherent cells, including HEK293, MSCs, fibroblasts, and other cells. Additionally, we have developed a characterization toolbox that addresses exosomes attributes such as biophysical properties (size, concentration, zeta potential, integrity), molecular properties such as surface biomarkers and cargo (e.g., protein and RNA content) and bioactivity (e.g., cellbased assays). Through this toolbox, we leverage nanoflow cytometry to analyze the biophysical, molecular, and functional attributes of exosomes. This helps overcome the “swarm effect” in standard flow cytometry, enabling quantitative assessment of exosomes at the single-particle level. Moreover, technologies such as single particle analysis and omics platforms such as mass spectrometry and next-generation sequencing enable quantitative assessment of exosome integrity and molecular cargo, informing about product quality and consistency. Other technologies, such as size exclusion chromatography using ultra-high performance liquid chromatography (SEC-UHPLC) and residual assays, provide insights on process-related impurities and contaminants that must be strictly controlled to help ensure product safety. By integrating these advanced analytical methods in one end-to-end offering, we aim to ensure robust characterization and quality control throughout the exosome manufacturing process. Collaborations between biotech companies like Exogenus Therapeutics and CDMOs like Lonza are pivotal in accelerating the development of exosome-based therapies. From Lonza’s perspective, what are the key advantages for developers in collaborating with a CDMO that possesses specialized expertise in exosome manufacturing? How does Lonza support developers in navigating the complexities of process development and scale-up? Collaborations between biotech companies and CDMOs like Lonza are crucial in accelerating the development of complex exosome-based therapies. For drug developers, this collaboration offers several key advantages, including leveraging specialized expertise and cutting-edge technologies. At Lonza specifically, drug developers benefit from our end-to-end exosome manufacturing capabilities, which can significantly de-risk the path to IND submission, clinical development, and commercialization. By leveraging Lonza’s process development expertise, including access to exosome loading technologies and bioactivity assays, both early- and late-stage developers can navigate the complexities of process development and scale up with confidence. Furthermore, Lonza has developed an innovative standard platform to enable large-scale perfusionbased production of GMP exosomes from HEK293 cells. Through this platform, drug developers can access perfusion-based upstream processes, chromatography-based downstream processes, and proprietary formulation techniques. Drug developers seeking to manufacture exosomes can leverage our New Product Introduction (NPI) system to design bespoke processes. This NPI system helps companies establish Current Good Manufacturing Practices (cGMP)-compliant manufacturing standards customized for cell and gene therapies. The system also enables oversight throughout a product’s lifecycle, including validation for process robustness, raw materials, analytical methods, sterility, facility, equipment, and tissue acquisition. In addition to new technologies, CDMOs can offer regulatory guidance for drug developers to align their LONZA
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