Human serum Albumin

Human serum albumin (HSA EP/USP) is manufactured from plasma sourced from our US-based FDA- and EMA-approved plasmapheresis centers. The product is licensed according to EP and USP standards. Human serum albumin (HSA) is widely used as an excipient in the pharmaceutical, biotechnology and cell-therapy industries. Some of its applications include: - Cell Culture, Vaccines, in vitro fertilisation, stem cells and cryopreservation Stabiliser - Drug formulation, vaccines and cell therapy - Carrier, Medical imaging, drug carrier (albumin-bound nanoparticles) High-Quality Services and Expertise - Grifols Bio Supplies provides high quality HSA along with assistance and expertise to ensure the most straight forward path for product registration. Plasma Quality: From Donor to Finished Products - Grifols Bio Supplies human serum albumin (HSA) is manufactured from plasma collected at our US-based FDA- and EMA-approved plasmapheresis centers. Our production strictly adheres to cGMP, the standards of the International Quality Program (IQPP) established by the Plasma Protein Therapeutics Association, and additional Grifols quality requirements. Production facilities are fully compliant with US FDA and EU regulations. The resulting albumin solution is pasteurized, highly purified, and licensed under both USP and EP standards. Experts in Worldwide Product Registration - Regulatory requirements are increasingly more stringent and consequently the process of registering 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 human serum albumin (HSA) product that complies with the regulatory requirements of multiple health authorities, allowing our customers to streamline the regulatory process. Let us help you overcome all obstacles standing in the way of smooth product registration around the world.