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PLTGold® HPL, Research Grade

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PLTGold human platelet lysate is a growth factor rich, xeno-free, heparin-free supplement that is a superior alternative to FBS or human AB serum for the growth of MSCs and T Cells. Research-grade, FDA Master File available, US origin.

Grouped product items
SKUSIZEPRICE QTY
PLTGOLD27R27 mL
$115.00
- +
PLTGOLD100R100 mL
$430.00
- +
PLTGOLD500R500 mL
$1,825.00
- +
PLTGOLD1000R1000 mL
$3,250.00
- +
Details
Sample Data
Resources
FAQs
Reviews 1
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Description
Specifications
More Information
SKUPLTGOLD-RUO
Intended useMedia supplement, cell culture, cell therapy research, drug discovery, MSCs, T Cells, Hematopoietic Stem Cells, and iPSCs
Osmolality250 - 330 mOsm/kg
Endotoxin< 10.0 EU/mL (available on clinical grade only)
Shelf-Life36 months from date of manufacture
pH6.8 - 7.8
Storage- 20 °C
MycoplasmaNot Detected
Cellular KineticsPass
Platelet TestingInfectious diseases including HIV-1, HIV-2, HIV-NAT, HCV, HBsAg, and serologic tests for Syphilis, ZIKV NAT, WNV NAT
Total Protein4.0 - 6.5 g/dL
SourceUS donors, AABB-accredited and FDA-registered blood banks
Superior cell performance

Human Platelet Lysate (HPL) provides superior cell performance and cell expansion when compared to other supplements such as FBS or chemically defined media. PLTGold® HPL is a revolutionary xeno-free, heparin-free supplement which provides rapid cell expansion with proven success across various cell types including MSCs and immune cells. Available in research and clinical grades, PLTGold® is an excellent supplement to cell culture media and for use in both 2D and 3D culture systems with a focus on research and cell therapy applications.

Features
  • Heparin-free
  • Lot-to-lot consistency allowing for reproducible manufacturing
  • Rapid cell expansion when compared to FBS or chemically-defined media
  • Sourced from FDA-registered blood centers
  • FDA Master File available
Sample Data

Figure 2. Real time imaging of adipose-derived MSC growth using PLTMax® or PLTGold® Human Platelet Lysate as a media supplement showed increased cell growth kinetics compared to cells grown in medium supplemented with FBS or Human AB Serum.

Resources
Documents
References
  1. Bhat, S., et al. 2021. Expansion and characterization of bone marrow derived human mesenchymal stromal cells in serum-free conditions. https://doi.org/10.1038/s41598-021-83088-1
  2. Ankrum, JA., et al. 2019. Nature vs. Nurture: Defining the Effects of Mesenchymal Stromal Cell Isolation and Culture Conditions on Resiliency to Palmitate Challenge. Front Immunol. PMID: 31134100
  3. Alonso-Camino, V., et al. 2017. In vitro expansion of mesenchymal stem cells using media supplemented with unfractionated, heparin-free platelet lysate. Volume 19, Issue 5, Supplement, Pages e16-e17.
  4. Burnouf, T., et al. 2016. Human platelet lysate: Replacing fetal bovine serum as a gold standard for human cell propagation. Biomaterials. 2016 Jan;76:371-87. doi: 10.1016/j.biomaterials.2015.10.065. Epub 2015 Oct 28. PMID: 26561934.
  5. Crespo-Diaz, R.et al. 2010. Platelet lysate consisting of a natural repair proteome supports human mesenchymal stem cell proliferation and chromosomal stability. Cell Transplant. 2011;20(6):797-811. doi: 10.3727/096368910X543376. PMID: 21092406
FAQs

Where can I find the Master File for PLTGold and PLTMax on the FDA website?

Since Human Platelet Lysate is considered a biologic and not a drug, its submission and documentation are now handled by the FDA’s Center for Biologics Evaluation and Research (CBER), who recognizes these submissions with Master File numbers. CBER does not currently publish the Master Files on the FDA’s website.

What is the difference between a Drug Master File and Master File?

Drug Master Files (DMF) are recognized by the FDA’s Center of Drug Evaluation and Research (CDER) agency for submissions made regarding the manufacturing, processing, packaging, and storing of human drug products. Master Files (MF) are recognized by the FDA’s Center of Biologic Evaluation and Research (CBER) agency for submissions made regarding the manufacturing, processing, packaging, and storing of human biologics. While there was overlap in regulatory oversight for biologics and drugs, the FDA created two independent specialized centers with premarket review and oversight responsibilities to deal with each product type, given their extremely different composition and manufacturing protocols

What is the intended use for platelet lysate?

Large-scale expansion of cells including MSCs, T-cells, hematopoietic stem cells, iPSCs, tumor cells, and fibroblasts.

Can PLTGold be used in clinical trials?

Yes, PLTGold is a completely xeno-free supplement that does not require heparin (or used in the manufacturing process). PLTGold has an FDA registered Master File available for reference.

What is PLTGold human platelet lysate?

PLTGold is a completely xeno-free human platelet lysate which contains all essential growth factors for healthy cell growth. Donor units are pooled in large batches and manufactured by Mill Creek Life Sciences under a proprietary method to produce highly consistent and reliable lots.

Reviews 1
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