GCSF (granulocyte-colony stimulating factor) is a haematopoietic growth factor that works by encouraging the bone marrow to produce more white blood cells. Growth factors are special proteins which are produced naturally in the body.

Patients who are undergoing chemotherapy lose white blood count which can lower their body resistance. GCSF can be given as an injection to stimulate the bone marrow to produce new white blood cells quickly.

Worldwide rights and Technology Transfer

SciGen has signed a technology transfer agreement which will allow SciGen to manufacture GCSF at its newly acquired facility in Pune, India. SciGen India will comply with Good Manufacturing Practice (GMP) and other requirements of European Medicines Evaluation Agency (EMEA) and other regulatory agencies such as the TGA in Australia and the FDA in the USA.

Manufacturing Process

Scilocyte™ is produced in genetically engineered E.Coli. The product is expressed in the form of inclusion bodies (insoluble aggregates inside the bacterial cell). After fermentation, the bacteria are lysed, and the inclusion bodies are isolated, the protein is folded and the product is purified by a series of chromatographic steps. The finished product, Scilocyte™, is manufactured by formulation into acetate buffer.