Biosimilar of Granulocyte-Colony Stimulating Factor (Filgrastim) and PEGylated G-CSF (Pegfilgrastim)

The engineered construct for E. coli expression, process for purification, characterization and in vitro bioactivity assay, in vivo bioactivity assay and hands-on training to people, to perform the same. PEG conjugation reaction conditions and purification of PEGylated G-CSF, characterization and in vitro and in vivo bioactivity assay and hands-on training.

Chemotherapy constitutes an indispensable component of the cancer treatment. Since chemotherapeutic drugs are cytotoxic and one of the critical side effects of chemotherapy is myelosuppression associated neutropenia. Chemotherapy induced neutropenia could predispose cancer patients to fatal infections and multi-organ failure. Clinical management of neutropenia with administration of Granulocyte-Colony Stimulating Factor (G-CSF) has played an instrumental role in improving the outcome of chemotherapy. However, administration of G-CSF leads to escalation in the cost of cancer management. G-CSF is also used for patients suffering from leucopenia, AIDS, sepsis and in bone-marrow transplantation.Furthermore, current research indicates multiple roles of G-CSF as a safe and efficacious drug, with potential of treating diseases beyond neutropenia. According to recent market survey, it is estimated that because of increasing demand of G-CSF, the market value of G-CSF would double in next five years. In the light of this information, we have developed G-CSF biosimilar and PEGylated G-CSF biosimilar. The G-CSF biosimilar technology is ready at the shake-flask level and we are working to develop the process for high-density fermentation

PEGylated G-CSF has longer half-life and is administered once per cycle of chemotherapy.