What are Exosomes?
Exosomes are small membrane extracellular vesicles (EVs) that consist of a heterogeneous population of small EVs (30-100nm in diameter) and micro vesicles (100-1000nm in diameter). Exosomes are secreted by a multitude of cell types that play key roles in cell-to-cell communication, including Mesenchymal Stem Cells (mSCs). Exosomes are found in most body fluids and have been shown to play key roles in processes such as coagulation, intercellular signaling, immune responses, and cellular waste management because they contain bioactive molecules, including proteins, RNAs and microRNAs.
Broad applications of exosomes have included delivery of biologics payloads to cells such as DNA, mRNAs, peptides and proteins, therapeutics treatments for Covid-19, cancer, rare diseases, and in the cosmeceutical applications.
Manufacturing of Exosomes
Exosomes are a novel form of biotherapeutics, but their production and purification are similar to conventional biologics manufacturing in terms of cell culture and bioreactor (upstream) and purification (downstream) development.
Goodwin experiences and expertise with the process development and optimization, scale up, and GMP manufacturing of exosomes. These include cell culture and expansion from a RCB, MCB or WCB using shake flasks, bioreactor, cell factories, and other systems.
Common Challenges in Manufacturing
From a manufacturing perspective, the challenge resides not only in the manufacturing but also in the characterization of the biologic. We are still in the early stages and most developers of these innovative technologies are in preclinical and early clinical stages working towards the demonstration of the efficacy and the potential of exosomes based therapeutics and cosmeceutics.
Goodwin can partner with you in the development of the following stages of manufacturing:
- Cell culture expansion, cell factories and bioreactor
- Purification development through the utilization of affinity ligand chromatography, Ion-exchange and other chromatography systems for therapeutic grade exosomes
- Utilization of a cell based assay to determine the exosome concentration
Advance your biologic
Contact us to learn about how we can advance your complex biologic.