PLASTEM®: our human plasma
supplement for cell culture
PLASTEM® is a pharmaceutical-grade alternative of human origin specially developed to overcome the limitations of products currently used to supplement cell culture media, such as foetal 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
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.
- Pharmaceutical grade xeno-free
- No batch-to-batch variation, as it is manufactured from plasma pools including thousands of donations
- Easy to handle: lyophilised 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: 100g 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)3
- Peripheral blood mononuclear cells (PB-MCs)
- Bone marrow mononuclear cells (BM-MNCs)
- Primary cell cultures
- African green monkey kidney cells (Vero)
- Human foetal lung cells (MRC-5)
- BALB/c mouse myeloma cells (P3X63Ag8.653)
- Chinese hamster ovary cells (CHO)
Quality and safety of PLASTEM®:
Grifols Quality System has both EMA and FDA licenses for production and commercialisation of plasma derivatives:
- GMP quality system
- Quality and safety 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
Please contact us for additional information
EMA: European Medicines Agency; FDA: Food and Drug Administration (United States).
Grifols has 295 plasma donation centers globally: 252 in the U.S. and 43 in Europe (Germany).
4 fractionation plants are located in:
- Clayton (North Carolina, U.S.)
- Los Angeles (California, U.S.)
- Barcelona (Spain).
Human Plasma Supplement for Cell Culture – PLASTEM®
Download a brochure about PLASTEM®, a product developed by Grifols to overcome the limitations of current products used to supplement cell culture media.
- EMA. 30 May 2013. Guideline on the use of bovine serum in the manufacture of human biological medicinal products. EMA/CHMP/BWP/457920/2012 rev 1. Committee for Medicinal Products for Human Use. European Medicines Agency.
- Rodríguez-Pizà I, Richaud-Patin Y, Vassena R, et al. Reprogramming of human fibroblasts to induced pluripotent stem cells under xeno-free conditions. Stem Cells. 2010 Jan;28(1):36-44.
- Díez JM, Bauman E, Gajardo R, et al. Culture of human mesenchymal stem cells using a candidate pharmaceutical grade xeno-free cell culture supplement derived from industrial human plasma pools. Stem Cell Res Ther. 2015 Mar 13;6:28.