The next generation human Platelet Lysate
PLSOLUTION-FDi GMP-Clinical Grade is a gamma-irradiated and fibrinogen-depleted cell culture supplement based on human Platelets. Consequently, PLSOLUTION-FDi complies the high safety guidelines for clinical applications. Virus panel testing is performed according to ICH and EMA guidelines (ICH Q5A (R1) and CPMP/BWP/268/95).
PLSOLUTION-FDi meets the requirements of evolving global regulations regarding the reduction of adventitious agent transmission (according to the European Pharmacopeia General Chapter 5.2.12). Thus, the human platelet-derived culture supplement ensures a high safety and quality level: PLSOLUTION-FDi enhances expansion of different human and animal cell types for clinical and therapeutic applications.
PLSOLUTION-FDi does not require any heparin addition in cell culture. Some traces of a pharmaceutical heparin may be present in the growth promotor.
PLSOLUTION-FDi is manufactured and gamma-irradiated under GMP conform conditions to allow the application in clinical environments.
PLSOLUTION-FDi is manufactured from platelet units obtained from healthy blood donors at FDA-licensed blood centres.
Certificate of Analysis (CoA) and Safety Data Sheet (SDS) are available upon request.
We provide PLSOLUTION-FDi GMP-Clinical Grade in validated Nalgene® bottles in different sizes.
Our regular shipping days are Monday – Wednesday in order to ensure a consistent quality of our products, especially for shipments containing dry ice.
For further information, please see our Terms and Conditions or contact us:
+49 (0) 241 95719-100