Green Cross Biotherapeutics’ Bio-manufacturing Facility, Montreal, Canada

Green Cross Biotherapeutics is setting up Canada’s first IVIG and albumin manufacturing plant.

Green Cross Biotherapeutics (GCBT), a biopharmaceutical company and member of the Green Cross family, broke ground on the construction of Canada's first intravenous immunoglobulin (IVIG) and albumin manufacturing plant in Montreal, Quebec, in June 2015.

The new facility, claimed to be one of the biggest green field investments in the Canadian biopharmaceutical industry, is part of GCBT's global expansion strategy and will serve as the North American headquarters for the group. It is also the first project to be set up through the Canada-Korea Free Trade Agreement.

The plant will be completed in the third quarter of 2016, while commercial production is scheduled to begin in 2019.

It will supply/export therapeutic plasma-derived products to local and international markets, including the US and China, while also establishing a stable local source for Canadian customers.

Héma-Québec, a non-profit organisation that manages the supply of blood in Quebec, agreed to purchase IVIG products manufactured by GCBT's plant for five years after the plant begins production.

Green Cross Biotherapeutics' manufacturing plant location and benefits

"The plant will be completed in the third quarter of 2016, while commercial production is scheduled to begin in 2019."

Green Cross Biotherapeutics' new state-of-the-art manufacturing facility is being constructed in the Saint-Laurent campus of Montreal Technoparc, an industrial park in Montreal.

The Saint-Laurent campus, a science park with more than 90 technology companies, facilitates the emergence of new companies.

The campus currently has more than 5,620 employees, while GCBT will add 200 more jobs through the new facility that requires qualified engineers, scientists, microbiologists and other professionals for the production and distribution of products.

Details of the IVIG and albumin manufacturing plant

GCBT planned Project Oasis with an aim to expand its business to North America and Europe.

The new plant marks the beginning of Project Oasis and will become the key project by serving as a North American hub for the production and distribution of various therapeutic products from the company.

Conceptual design for the plant was completed in January 2015 and the basic design was ready by April 2015.

The plant will have a gross floor area of 225,000ft² constructed on a 700,000ft² plot. The plant will be built in accordance with current US and Canadian good manufacturing practices (cGMP). It will be equipped with innovative and technologically advanced process equipment.

The plasma fractionation facility will have state-of-the-art filling and packaging areas to produce final bulk products for commercial use.

Products at the new manufacturing plant

McGill University Health Centre (MUHC) and Research Institute of the MUHC (RI-MUHC) inaugurated a new research institute that was jointly built at MUHC's Glen, Montreal site in February 2015.

The new plant will manufacture two plasma-derived products including intravenous immunoglobulin (IVIG) 5% and 10%, and albumin 5%, 20% and 25%.

IVIG is a high-purity IgG manufactured from plasma derivates collected from individual donors. It is a key therapeutic solution for infectious and immune diseases.

GCBT plans to launch IVIG 5% in the US by 2017, and IVIG 10% for the Canadian and US markets by 2019.

Albumin is a hypoalbuminemia drug manufactured from normal plasma, using the cold ethanol plasma fractionation method. It is used in the treatment of burns and as a blood-volumising agent.

GCBT will manufacture albumin 5%, 20% and 25% for Canada, US and China from 2019.

Production capacity

The new plant will have an initial capacity of one million litres of plasma a year.

At full capacity, it is expected to generate annual revenue of approximately $228m through its own manufacturing products and a total sales turnover of more than $380m, including imported and distributed goods.

Financing for GCBT's new plant in Montreal Technoparc

The total estimated investment for the project is C$315m ($239m).

Investissement Québec, a joint stock company that promotes investments in Quebec through financial assistance, provided a loan of C$17m ($12.9m) for the project along with a tax benefit of C$8m ($6m).

The Korean National Pension Service, a private equity fund, is contributing C$70m ($53m) in equity.

Marketing commentary

Green Cross Corporation established GCBT in 2014 in a strategic move to expand its business into North America and Europe.

Based in Yongin, South Korea, the company provides safe and effective healthcare solutions and specialises in developing and manufacturing plasma derivatives, recombinant proteins, preventive vaccines and therapeutic antibodies.