GC Biotherapeutics Inc. (GCBT) upon commercialization intends to have the following plasma-derivative products available.
IVIG 10% will be manufactured by GCBT for the Canadian and US market.
Product image is current IVIG 5% product manufactured in South Korea.
ALBUMIN 5%, 20% and 25%
*Information provided here is for current South Korea manufactured Albumin 20% product.
*Albumin 5%, 20% and 25% will be manufactured by GCBT for Canada, US, and China market:
- By commercialization : Available for Canadian market (Albumin 5%, and 25%) and export (Albumin 20%);
- Post-commercialization : Available for US market (Albumin 5%, 20% and 25%).
- The plasma-derivative product ALBUMIN is a hypoalbuminemia drug that has a yellow to yellowish transparent liquid formulation.
- A 20% solution of purified human serum albumin is manufactured from normal plasma by the cold ethanol plasma fractionation method.
- After purification, stabilization and passage twice through a sterilizing filter, it is heated to 60 ℃ for 10 hours. This heat treatment completely destroys the causative agents such as Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV) and so on. There are no known cases of viral diseases which have resulted from the administration.
- Albumin injection 20%-GCC contains no preservative and is free from plasma proteins associated with the blood clotting mechanism and blood group antibodies.
- Store at or below 30 ℃ without freezing in a hermetic container.
- Shelf life: 39 months
Ingredients per 100 ml\vial contains
- Normal human serum albumin …………. 20 g
- 50 ml/vial x In-house packing unit
- 100 ml/vial x In-house packing unit
Product image is current ALBUMIN 20% product manufactured in South Korea.
- For the hypoalbuminemia and shock in acute hemorrhage by loss of albumin (burns, Nephrotic syndromes, etc.) and low synthesis of albumin (hepatic cirrhosis, etc.)