Additional Information
PLASTEM® : Our Human Plasma Supplement for Cell Culture
PLASTEM® is a GMP alternative of human origin specially developed to overcome the limitations of some of the products currently used to supplement cell culture media, such as fetal bovine serum (FBS)1.
Applications of PLASTEM®
PLASTEM® is suitable for cell culture media supplementation.
FBS replacement for:
- Cell therapy
- Advanced therapy medicinal products (ATMP)
- Cell culture research
- Stem cell research
Characteristics of PLASTEM®
PLASTEM® is an additive for the culture of different cell lines. It is obtained from human plasma following a fractionation process based on the Cohn method.
- GMP xeno-free
- No batch-to-batch variation, as it is manufactured from plasma pools, including thousands of donations
- Easy to handle: lyophilized product for reconstitution in cell culture media or water
- Storage at room temperature for three years at 2-30 ºC
- Composition per vial: 1.5 g of human plasma proteins (mostly albumin)
- Composition per tray: 100 g of human plasma proteins (mostly albumin)
Performance of PLASTEM®
PLASTEM® is derived from human plasma and can be used for cell culture supplementation as it supports the growth of several cell lines. Cell lines grown with PLASTEM® include:
- Human mesenchymal stem cells (hMSCs)2
- Human embryonic stem cells (hESCs)1
- Peripheral blood mononuclear cells (PBMCs)
- Bone marrow mononuclear (BM-MN)
- Primary cell cultures
- African green monkey kidney cells (Vero)
- Human fetal lung cells (MRC-5)
- BALB/c mouse myeloma cells (P3X63Ag8.653)
- Chinese hamster ovary (CHO)
Quality & Safety of PLASTEM®
Grifols Quality System has both EMA and US FDA licenses for production and commercialisation of plasma derivatives:
- GMP quality system
- Quality and safety levels of a human plasma-derived medicine applied to PLASTEM®
- Grifols plasma derivatives are used worldwide (in more than 90 countries)
- Plasma is collected from healthy donors in US-based FDA and EMA licensed plasma centres
- Same controls and analytical tests as for plasma-derived intravenous (IV) therapeutic products, e.g. albumin, immunoglobulins and clotting factors
- Specific production steps with viral inactivation capacity
- Gamma irradiation treatment
- Additional purification processes contribute to the product's safety through validated viral removal capacity
- Scalability
- Grifols has more than 300 licensed collection centers located in the US and Europe and 4 fractionation plants located in Clayton (North Carolina, US), Los Angeles (California, US), Barcelona (Spain).
