IFN b 1b Human

The gene for interferon beta was originally cloned from human fibroblasts. To create IFN-beta 1b, scientists altered the gene to substitute serine for the cysteine residue found at position 17 . This recombinant protein is produced in Escherichia coli (E. coli) cells, which do not glycosylate the protein, resulting in a form that differs slightly from the natural human interferon beta .

IFN-beta 1b works by modulating the immune system. It reduces the frequency and severity of MS relapses by inhibiting the production of pro-inflammatory cytokines and enhancing the production of anti-inflammatory cytokines. This helps to reduce the overall inflammatory response in the central nervous system .

IFN-beta 1b is used to slow the progression of relapsing-remitting multiple sclerosis (RRMS) and to reduce the frequency of clinical symptoms . It is administered via subcutaneous injection, typically every other day. The treatment has been shown to reduce the number of new lesions in the brain and spinal cord, as well as to decrease the frequency of relapses .

The production of IFN-beta 1b involves several key steps:

1. Cloning and Expression: Scientists at Fraunhofer IGB have developed a highly productive clone that expresses the IFN-beta 1b gene sequence adapted to E. coli. This allows for high expression rates of the desired protein within the cells .
2. Fermentation: High-cell-density fermentation is used to achieve a stable and high expression rate of at least 20% IFN-beta 1b in the total cell protein .
3. Purification: The purification process involves centrifugation of the homogenates, followed by extraction and chromatographic techniques to isolate the IFN-beta 1b protein .

With the patent protection for IFN-beta 1b running out, there is an opportunity to make this treatment available as a biosimilar to a broader group of patients at a more reasonable cost . This could significantly improve access to treatment for the approximately 2.5 million MS patients worldwide .