The firm - a subsidiary of Korean-based drugmaker Green Cross - is investing CA$315 (US$255m) in the 225,000 sq ft plant located on the Montreal Technoparc's Saint-Laurent Campus, in order to produce plasma protein products for the domestic, US and international market.
“The facility will have the capacity to fractionate one million liters of plasma per year, yielding up to five tons of immunoglobulin (IVIG), depending on the source of plasma, and approximately 25,000 kg of albumin,” Joon Han, Managing Director at Green Cross Biotherapeutics told Biopharma-Reporter.com.
IVIG is used to treat immune deficiencies, autoimmune diseases and acute infections, and is sold by firms including Baxter (as Gammagard) and CSL Behring (as Privigen). Albumin is used as a blood-volumising agent and to treat burns.
These are sterile injectable products essential to the health of Canadian and American patients, Han explained, and North America accounts for more than 40% of the total global market. Furthermore, “Canada is currently relying solely on imports [and so] it will greatly benefit from having a domestic manufacturer.”
Commercial production is expected to begin in 2019 and more than 200 scientists, engineers, microbiologists, chemical engineers and other professionals will be employed at the site.
Plasma Protein Production
Once operational, the site will manufacture IVIG and albumin using the Cohn-Ethanol fractionation method which is a series of purification steps based on the different physical properties of the plasma proteins, used to extract immunoglobulin and albumin.
“Using innovative technology transferred from Korea, the immunoglobulin and albumin are processed through a series of purification and virus inactivation/removal steps, yielding to purified bulk products,” we were told.
Following this, “bulk immunoglobulin and albumin are aseptically filled into vials and then packaged into finished products.”
The facility will be equipped with some single-use technologies “in certain areas of the process where it is economically and technically feasible to do so,” Han added.