Exosome

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Porton Advanced offers end-to-end exosome CDMO services, spanning early-stage research to commercial-scale production. With cutting-edge expertise in cell culture, exosome isolation, purification, and characterization, we deliver high-purity, high-quality exosome solutions. Our advanced technologies and scalable processes empower seamless transitions from R&D to commercialization, ensuring reliable and efficient outcomes for our partners.

  • Cell expansion (MSC, HEK293, or other cell lines)
  • GMP manufacturing (up to 500L)
  • Process development and optimization
  • Analytical method development and optimization, analytical qualification, and validation
  • CMC information writing and regulatory submission

Process development and GMP manufacturing

Porton Advanced's technical team possesses extensive hands-on manufacturing experience in mesenchymal stem/stromal cells (MSC) and HEK293 cell culturing and expansion. Our state-of-the-art GMP facility and first-class instruments enable the reliable delivery of exosome projects.

Here is an example process for mesenchymal stem/stromal cells (MSC)/HEK293 expansion:

RCB - Shake flask/cell factory - Primary cell banking- Shake flask/cell factory - Master cell banking - Shake flask/cell factory - Working cell banking - Analytical testing- Release.

Here is an example process for exosome production:

The process is easy to scale up, yielding high exosome amounts (over 50%) and resulting in low impurity residue (HCP < 300 ng/mL, HCD < 100 ng/mL).

Comprehensive analytical and testing strategies

Analyzing exosome products' structure, composition, and function is essential for standardized industrial manufacturing. Porton Advanced utilizes various analytical techniques and instruments to characterize the exosomes produced. The key biochemical profile includes  the number of particles, both positive and negative exosome markers, etc.

Type CQA
Regular test Appearance
Regular test PH
Regular test Osmolality
Regular test Volume
Regular test Morphology
Regular test Particle size
Regular test Physical concentration
Regular test Total protein
Regular test Purity 
Regular test Positive marker proteins
Regular test Negative marker protein   (Calnexin)
Impurity
HCD
Impurity
Size distribution of residual DNA
Impurity HCP
Impurity
Residual benzonase
Impurity Sterility
Impurity Endotoxin
Impurity Mycoplasma
Impurity Adventitious agents
Impurity EOPC identification

Case studies

We achieved high-quality exosomes with a high cell density (3E7 cell/mL) after 11 days of culturing from the HEK293 cell line. 

Testing results of HEK293-based exosome samples were obtained using NanoCoulter.

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