The board of directors of Grifols has approved a plan for new industrial investments for the Bioscience Division for the period 2016-2021, with the goal of expanding the manufacturing capacity to cover the expected growing demand of plasma-derived products for the upcoming years. The company plans to invest $360 million to increase plasma fractionation capacity and purification of the several proteins. The company made the announcement on March 8, 2016.

As part of this investment, the company plans invest $90 million to construct a new plasma fractionation plant at the industrial complex in Clayton, North Carolina, with a fractionation capacity of 6 million liters per year. The construction will begin the first quarter of 2017 and is scheduled to start production in early 2022.

Plasma fractionation is the process of extracting the different fractions that contain the proteins with therapeutic uses. Afterwards, these fractions are purified and sterilized in specific plants for each of the proteins obtained. To process the fractions that will be produced in the new plasma fractionation plant, and then obtain the proteins, three new purification and sterile filling plants will be constructed for three of the main proteins commercialized by Grifols. The first facility is a new, $120 million purification plant for intravenous immunoglobulin (IVIG) at the Clayton facility to process the fraction II+III from the new fractionation plant to obtain between 25 and 30 million grams/year of IVIG, under the Gamunex brand. The plant is scheduled to come into operation in late 2021.

The second plant is a $85 million purification plant for albumin at the Grifols facilities in Dublin (Ireland) with capacity to produce between 130 and 150 million grams/year of albumin (Albutein), from fraction V. The company schedules to bring forward the construction of this plant to cover the particularly growing market demand of this protein. The construction is scheduled to commence at the end of 2016, so it will begin production in early 2020.

The third plant is a $65 million purification plant for alpha 1-antitrypsin (Prolastin) at the Grifols site at Parets del Vallés (Barcelona, Spain). The company projected to reach full capacity to purify this protein by 2018. Therefore, in 2014, a decision was taken to start the construction of this plant. It is expected that US Food and Drug Administration and European Medicines Agency licenses will be granted in late 2017 or early 2018.

The current purification plants to obtain other plasma proteins such as factor VIII or factor IX have sufficient capacity to absorb the increase that may be generated by this new fractionation plant.

This $360 million investment plan considers that the start of new production facilities require an average of approximately five years once the investment is approved until the regulatory authorizations are granted to start the commercialization of products. Grifols estimates that the production capacities will be sufficient to ensure Grifols’ ability to cover the expected growing demand in its markets until 2028-2030. All the projects will be designed and executed by Grifols Engineering, an-house company specializing in the construction of this type of facilities.

In 2015, Grifols launched a new plan to open plasma donor centers in the United States The new fractionation plant will increase Grifols’ plasma requirements. To ensure the equivalent plasma supply, in 2015, the company approved a new program to open new plasma donor centers in the United States, as well as to expand, renovate and relocate existing centers. It is scheduled to open progressively 75 new centers with the aim of bringing the total number of centers up to 225 by 2021. The company now has 160 operating centers. In addition, Grifols has planned to construct a third testing laboratory to handle the increased number of samples, mainly, from these 75 new plasma centers. It is expected to come into operation by 2019.

In preparation for increased raw materials, two logistics and plasma warehousing centers have been already constructed, one at the Clayton complex, with a capacity to store 3.7 million liters, and the other in Dublin with a capacity for 800 thousand liters. Both facilities are scheduled to be fully operational by the end of 2016.

Source: Grifols