Extracellular Vesicle Development and Manufacturing

At NorthX Biologics, we provide expertise in development and GMP manufacturing for extracellular vesicle products. Our capabilities span both microbial and mammalian derived vesicles as well as engineered vesicle production strategies.

Flexible platforms for complex products

Extracellular vesicles (EV) are becoming an attractive new therapeutic modality for both immunotherapy and as vectors for various cargos such as nucleic acids and proteins, representing a major advancement in drug delivery and biologics. EVs offers a natural and highly adaptable platform for vaccines and delivery vehicles.  

Being complex structures with an inherent heterogeneity, manufacturing for clinical stage requires special attention. Building on our long track record from development and manufacturing of biologicals we ensure the flexibility to meet the special requirements of these highly complex products. 

Close up of OMV lab work

Bacterial Outer Membrane Vesicles (OMVs)

NorthX Biologics is engaged in multiple OMV-based projects, collaborating with global partners to push the boundaries of innovation in next-generation biologics. OMVs are EVs originating from gram negative bacteria consisting of lipids, proteins, and lipopolysaccharides.  

Our OMV manufacturing platform is highly adaptable and cater for the specific vesicle product needs. We can support in host cell screening and GMP grade cell banking in full compliance. To achieve the highest possible yield of functional OMVs, multivariate experimental design is applied to optimize the fermentation process in small scale systems.  

EV manufacturing lab work

Mammalian derived extracellular vesicles

EVs origin from animal derived or human cell lines are nanosized vesicles that play a critical role in intercellular communication by transferring proteins, lipids, and nucleic acids between cells.

Cell types used for therapeutic EV production include:

  • Mesenchymal stem cells (MSC)
  • Dendritic cells (DC)
  • Various immune cells

We offer a full range of culture systems spanning from T-flasks to Icellis500 fixed bed bioreactor for seamless scale up. For suspension culture, we offer solutions up to 250L culture volume. Isolation and purification are done using advanced technologies, to ensure high-purity EV products suitable for therapeutic applications.

Lab engineer in front of HPLC-machine

Analytical characterization

NorthX Biologics provides comprehensive analytical characterization for complex EV products, covering potency, purity, identity, and sterility.

Our in-house analytics ensure full control and rapid timelines. Technologies include:

  • Dynamic light scattering (DLS)
  • Flow cytometry (FACS)
  • dPCR/qPCR
  • Capillary Electrophoresis (CE)
  • HPLC
  • ELISA

We also conduct stability studies to monitor drug substance and product integrity, with thorough documentation and transparency throughout the process. 

Partner with us to progress your extracellular vesicle product

With expertise in CMC development, GMP manufacturing and regulatory compliance, we offer end-to-end support to EV-based therapies, from pre-clinical development to commercial scale production. Our state-of-the-art facilities and specialized knowledge in vesicle systems position NorthX Biologics as a leading partner in advancing extracellular vesicle technology, unlocking new possibilities in precision medicine and targeted drug delivery. 

Let's talk extracellular vesicles!

Let’s journey together

NorthX Biologics is dedicated to the journey of complex biologics. Let us know how we can help move your product forward.

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