Additional Information
Immunoglobulins are key immunological proteins that form a constituent part of human plasma. There are five main isotypes (IgG, IgM, IgA, IgD and IgE) with diverse effector functions. Grifols immunoglobulin is comprised of the isotype IgG. Immunoglobulin is used in a range of pharmaceutical applications, and it is increasingly being utilized in the cell and gene therapy fields.
Plasma Quality From Donor to Finished Products
Grifols immunoglobulin is manufactured from plasma originating from our own US and EU plasmapheresis centers, conforming to cGMPs, IQPP of the Plasma Protein Therapeutic Association (PPTA) and fulfilling additional requirements set by Grifols. Production processes and facilities are certified according to the US FDA and EU regulations Grifols immunoglobulin is licensed according to both USP and EP requirements.
Experts in Worldwide Product Registration
Regulatory requirements are increasingly more stringent and consequently the process of registering therapeutic biological products is particularly complex. As a manufacturer of biological products that are registered in many countries, at Grifols, we offer you valuable expertise in regulatory compliance around the world.
We can offer a single immunoglobulin product that complies with the regulatory requirements of multiple health authorities, allowing our customers to streamline the regulatory process.
Let Grifols help you overcome all obstacles standing in the way of smooth product registration around the world.
