Grifols given permission for new process at US plasma products plant
Grifols, the Spanish pharma company specialising in blood-related products, has received the go-ahead for a new, key process at its Los Angeles plasma production plant as part of its efforts to expand and improve facilities in Europe and the US.
Grifols, the Spanish pharma company specialising in blood-related products, has received the go-ahead for a new, key process at its Los Angeles plasma production plant as part of its efforts to expand and improve facilities in Europe and the US.
The US Food and Drug Administration has approved Grifols' new sterile filling area for coagulation factors. Grifols said the new purpose-built facilities are designed to ensure maximum safety in the aseptic filling, sterilisation and lyophilisation stages of the company's plasma products Factor VIII, Factor IX and Profilnine.
It is expected to start operating during the second half of this year.
FDA approval was the final stage in one of the first investments planned by the group for its Los Angeles plant to update and adapt the production processes to the standards in place at its plasma products plant in Barcelona.
The facility will also house a dedicated line for the sterile filling of albumin. It is in the second stage of construction and the company hopes to obtain FDA approval at the start of 2009.
The Los Angeles project is part of a Euro 400m spend to expand and improve Grifols" plants in Spain and the US over the next five years. Plans include new production facilities at its Barcelona complex to manufacture the biological adhesive fibrin glue, expand the filtering process for two blood derivatives and double plasma production from the current two million litres a year to four million in 2013.
In the US, the company plans to open new plasma gathering centres, a new laboratory for analysis in Austin, Texas, and a new Los Angeles plant to manufacture the company's next generation intravenous immunoglobin (human normal IVIG), Flebogamma.