With years of experience in exosome field, Creative Biolabs is now providing reliable and reproducible GMP-compliant exosome manufacturing services across a range of productions scales to suit the specific research needs of our clients. In addition to the scalable upstream production of exosomes, we also provide downstream processing for efficient purification and characterization, to obtain high-quality, functional exosomes that are ready to use. Moreover, robust manufacturing of both native and drug-loaded exosomes are available.

Introduction of Exosome Manufacturing

The manufacturing of exosomes first requires their secretion from appropriate cell lines such as stem cells and HEK 293 cells. Then, exosomes are isolated from the conditioned medium and separated from process-related contaminants including other extracellular vesicles, proteins, and cells. Thereafter, the harvested exosomes can be characterized by different techniques to ensure the quality and quantity of the final products. The process is divided into several key steps as follows:

Upstream cell line production methods. Fig.1 Upstream cell line production methods. (Colao, 2018)

  • Upstream Production – Cell lines (e.g., MSCs, ESCs) are cultured for exosome production with either T-flasks or hollow fiber bioreactors (HFBRs). In the former case, it takes several rounds of splitting and culture expansion to yield a large number of cells for exosome production. Often, the serum-free medium can be used to reduce contamination and to help exosome purification. In the latter case, the HFBRs have provided a platform for robust, reproducible, and scalable production of exosomes. The purification is simplified because the serum-free medium is not required.
  • Exosome Purification – Exosomes can be purified using a variety of methods after cell harvest, including ultracentrifugation and microfiltration, size exclusion chromatography, and immunoaffinity. To enable the production of scalable and pure exosome products, the most suitable approach and strategy will be adopted based on the starting volume and the intended downstream application of exosomes.
  • Exosome Analysis – In order to get a clear picture of the quality of your exosomes, we provide comprehensive characterization and quantification services. These include Nanoparticle Tracking Analysis (NTA), exosomal surface marker analysis (using FACS, WB, ELISA), physical observations (Mass spectrometry), and Tunable Resistive Pulse Sensing (TRPS). Besides, we can perform profiling services of the exosome cargo including RNA, proteins, and cfDNA.
  • Exosomes Loaded with Exogenous Cargo – Exosomes with loaded exogenous cargo can be manufactured according to your requirements.

Downstream exosome purification methods.Fig.2 Downstream exosome purification methods. (Colao, 2018)


Features

  • Highly feasible for different production scales and purification strategies
  • Streamlined services from consultation and project design, to product production and data interpretation
  • Ensured high quality, consistent reproducibility, and satisfying quantity
  • Amenable to different downstream applications and research purposes

Creative Biolabs is backed by both expert scientific support and the latest production technologies for every step of the exosome manufacturing process, from cell line development and exosome harvesting to exosome purification and characterization. If you are interested in our services, contact us to discuss your project requirements.

Reference:

  1. Colao, I.L.; et al. Manufacturing Exosomes: a promising therapeutic platform. Trends in Molecular Medicine. 2018, 24(3):242.

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45-1 Ramsey Road, Shirley, NY 11967, USA
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