Nanobodies, are a novel class of therapeutic proteins based on single-domain antibody fragments. Due to their small size and unique structure, they have shown great potential as next generation biological drugs. Existing methods for producing these nanobodies have come with certain drawbacks. A common method for production of nanobodies involves intracellular expression using the bacteria E-Coli. This involves the lengthy steps of releasing intracellular proteins for purification, as well as the complete removal of endotoxins, which would otherwise expose patients to harmful effects. Another approach for the production of nanobodies involves the use of lyophilized cell extracts. There are several potential problems with LCE systems, including difficulty in scaling up, batch-to-batch variability, and survival in harsh environments. 
There is therefore, a need to develop a lower cost, scalable method for the production of nanobodies with high stability and long shelf life, that are both safe and effective. 
Technology Overview
This technology involves the engineering of Bacillus subtilis spores for the production of nanobodies. This gram-positive bacteria contains minimum endotoxin levels, removing a key concern from the production of nanobodies through E-Coli. Additionally, unlike E-Coli which uses an intracellular expression process, the production of nanobodies through Bacillus subtilis uses a less complicated extracellular process. Both of these improvements have the potential to significantly simplify downstream purification efforts, leading to a lower cost and more scalable method of nanobody production. 
These spores are also known for their exceptional resistance and longevity, independent of their environment. Additionally, through the use of a cellulose binding domain, these nanobodies can be immobilized on cellulose-based materials for long term storage.
- Simplified process for production and purification 
- Superior stability against environmental extremes 
- Long shelf life 
- Lower cost method for production of nanobodies 
- Therapeutics (including: oncology, immuno-oncology, inflammation, rare diseases) 
- Diagnostics (rapid detection of antigen targets) 
- License
- Research collaboration
- Partnering
Patent Information:
For Information, Contact:
Vaibhav Saini
Senior Manager Commercialization
Northeastern University
Jiahe Li
Antibody manufacturing
Protein production