PLUS™ is a commercially manufactured human platelet lysate that serves as a cytokine rich replacement for fetal bovine serum (FBS). PLUS™ is prepared from platelets sourced from FDA-registered blood banks using state of the art manufacturing techniques and provides a safe, serology-tested product with minimal lot-to-lot variation. PLUS™ offers a true xenogenic-free culture platform that does not require addition of animal-derived anticoagulants (e.g., heparin). PLUS™ supports the culture of various human cell types, including mesenchymal stromal cells (MSCs), adipose derived stem cells (ASCs), dendritic cells, dermal fibroblasts, epidermal keratinocytes, and endothelial cells, and has been tested in both traditional culture systems and advanced bioreactor systems. PLUS™ is available as research grade in bottles and as GMP grade in bags.
Features and Benefits
- Human derived product rich in growth factors and other proteins
- No requirements for heparin addition making it a true xeno-free media supplement
- Extensive serology testing ensures safety for each lot
- Improved proliferation without loss of phenotype for numerous cell types such as mesenchymal stem cells (MSCs), adipose derived stem cells (ASCs), dendritic cells, fibroblasts, keratinocytes, natural killer cells, etc.
- Minimal lot-to-lot variation
- Availability of research grade and GMP grade allows seamless transition from research applications to those requiring extensive documentation
- Lower cell therapy manufacturing costs by providing higher cell yield in shorter time
- Availability of DMF for PLUS™ as an ancillary material for easier incorporation in clinical trials
GMP Grade PLUS™ Human Platelet Lysate
PLUS™ is available as research grade and GMP grade. While the manufacturing method for both grades of PLUS™ are the same, yielding products with similar performance, GMP grade indicates that the product has been prepared under cGMP requirements to ensure proper design, monitoring and control of the manufacturing processes, facilities and the final product
Availability in Cryobags - GMP PLUS™ is available in cryobags. Since product filling in cryobags is achieved using a fully “closed-loop” process, GMP product in bags are considered a safer and preferred option for use in clinical protocols that have been automated or use bioreactors for large scale manufacturing..
Product Testing and Release Criteria - In addition to the standard testing of donor material for infectious diseases and final product testing for bacterial and fungal contamination, mycoplasma and endotoxin levels, each lot is tested for cell growth and expansion of MSCs as part of quality control prior to lot release.
Drug Master File - A Drug Master File (DMF) for GMP PLUS™ hPL is on record with the US FDA to support our US customer’s submissions to the FDA. A DMF is a submission to the FDA that contains confidential information on a product’s raw materials, manufacturing, processing and packaging. The availability of DMF for PLUS™ as an ancillary material reduces the regulatory burden on clients significantly. Our drug master file has been referenced numerous times by our clients in academia and biotech for various IND filings. PLUS™ customers may make a request to Compass Biomedical to reference the DMF in their submission.
GMP PLUS™ hPL in Clinical Trials - GMP PLUS™ hPL has been used in numerous Phase 1 to Phase 3 clinical trials in North America and Asia. Autologous and allogeneic cells cultured in GMP PLUS™ have been administered to patients as part of IND approved clinical trials for various indications such as cystic fibrosis, rheumatoid arthritis, osteoarthritis, and hematological malignancies.
If you would like to have a more detailed technical discussion about adopting GMP PLUS™ into your cell therapy protocol, please contact info@compassbiomed.com. We are happy to work with you and provide the documentation needed to advance your research and development efforts.
Availability in Cryobags - GMP PLUS™ is available in cryobags. Since product filling in cryobags is achieved using a fully “closed-loop” process, GMP product in bags are considered a safer and preferred option for use in clinical protocols that have been automated or use bioreactors for large scale manufacturing..
Product Testing and Release Criteria - In addition to the standard testing of donor material for infectious diseases and final product testing for bacterial and fungal contamination, mycoplasma and endotoxin levels, each lot is tested for cell growth and expansion of MSCs as part of quality control prior to lot release.
Drug Master File - A Drug Master File (DMF) for GMP PLUS™ hPL is on record with the US FDA to support our US customer’s submissions to the FDA. A DMF is a submission to the FDA that contains confidential information on a product’s raw materials, manufacturing, processing and packaging. The availability of DMF for PLUS™ as an ancillary material reduces the regulatory burden on clients significantly. Our drug master file has been referenced numerous times by our clients in academia and biotech for various IND filings. PLUS™ customers may make a request to Compass Biomedical to reference the DMF in their submission.
GMP PLUS™ hPL in Clinical Trials - GMP PLUS™ hPL has been used in numerous Phase 1 to Phase 3 clinical trials in North America and Asia. Autologous and allogeneic cells cultured in GMP PLUS™ have been administered to patients as part of IND approved clinical trials for various indications such as cystic fibrosis, rheumatoid arthritis, osteoarthritis, and hematological malignancies.
If you would like to have a more detailed technical discussion about adopting GMP PLUS™ into your cell therapy protocol, please contact info@compassbiomed.com. We are happy to work with you and provide the documentation needed to advance your research and development efforts.
PLUS™ GMP Grade Gamma Irradiated Human Platelet Lysate
PLUS™ GMP Grade Gamma Irradiated Human Platelet Lysate (PLUS™- GR) has been developed to meet the pathogen reduction requirements of the 9th Edition of the European Pharmacopeia Monograph (General Chapter 5.2.12). PLUS™- GR has been gamma irradiated at 25-40 kGy for safe elimination of potential pathogens without compromising efficacy. The product is manufactured and gamma irradiated under cGMP for use in clinical cell culture protocols. PLUS™- GR is available in cryo-bags.
Gamma irradiation is the preferred method for viral inactivation of PLUS™ hPL for the following reasons:
Our process validation data show that gamma irradiation of PLUS™ hPL reduces the risk of potential virus contamination without significantly impacting product composition or cell culture performance
Gamma irradiation is the preferred method for viral inactivation of PLUS™ hPL for the following reasons:
- High penetration depth of the ionizing radiation
- Effective against a wide range of viruses
- Scalable in a GMP manufacturing process
Our process validation data show that gamma irradiation of PLUS™ hPL reduces the risk of potential virus contamination without significantly impacting product composition or cell culture performance
Gamma irradiation has minimal impact on hPL composition and performance
Gamma irradiation inactivates model viruses in PLUS™ human platelet lysate
Research Grade PLUS™ Human Platelet Lysate
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Research grade PLUS™ is manufactured using the same high-quality raw materials and a similar production process. The performance of research grade PLUS™ closely matches that of GMP grade PLUS™, and thus enables a seamless transition from early research and development applications to those requiring extensive, GMP-level documentation. Research grade PLUS™ is available in bottles.
In addition to standard testing of donor material for infectious diseases and final product testing for bacterial and fungal contamination, mycoplasma and endotoxin levels, each lot is tested for cell growth and expansion of MSCs as part of quality control prior to lot release. |
Ordering Information
To order or learn more about Compass Biomedical's PLUS™ Human Platelet Lysate, please feel free to contact our Customer Service at 855-hPL-PLUS (855-475-7587) or sales@compassbiomed.com.
Catalog Number |
Description |
Research Grade |
|
PLS1 |
PLUS™ MSC Qualified Human Platelet Lysate (100 ml) |
PLS2 |
PLUS™ MSC Qualified Human Platelet Lysate (250 ml) |
PLSA-0500 |
PLUS™ MSC Qualified Human Platelet Lysate (500 ml) |
GMP Grade |
|
PLS5 |
PLUS™ GMP Grade Human Platelet Lysate (100 ml) |
PLS6 |
PLUS™ GMP Grade Human Platelet Lysate (250 ml) |
Gamma Irradiated |
|
PLSGR-250 |
PLUS™ GMP Grade Gamma Irradiated Human Platelet Lysate (250 ml) |
Publications & References
- Viral Inactivation of Pooled Human Platelet Lysate Using Gamma Irradiation. ISCT Poster Presentation, Madison, 2019
- Modeling biological and economic uncertainty on cell therapy manufacturing the choice of culture media supplementation. Regenerative Medicine. 13(8), 917–933 (2018)
- Flow Preservation of Umbilical Vein for Autologous Shunt and Cardiovascular Reconstruction. Ann Thorac Surg. 2018 June ; 105(6): 1809–1818.
- Evaluation of Gamma Irradiated and Limited Donor Pool Human Platelet Lysate for Clinical Cell Manufacturing. ISCT Poster Presentation, Montreal, 2018
- Cost Effectiveness Analysis of Just-In-Time Expansion of Mesenchymal Stem/Stromal Cells (MSCs) With PLUS™ Human Platelet Lysate For an Allogeneic Clinical Trial. ISCT Poster Presentation, Montreal, 2018
- Cost Effectiveness Analysis of Expansion of Bone Marrow Mesenchymal Stem Cells and Adipose Stem Cells With PLUS™ Human Platelet Lysate. Cell and Gene Therapy Bioprocessing and Commercialization Poster Presentation, Boston, 2017
- Irradiation Methods for Pathogen Reduction of Xeno-Free Human Platelet Lysate. ISCT Poster Presentation, London, 2017
- Co-administration of First Trimester Umbilical Cord-Derived Perivascular Cells (FTM HUCPVCs) with Endothelial Progenitor Cells (EPCs) Leads to Enhanced Angiogenesis, both in vitro and in vivo, Compared to either Cell Type alone. ISCT Poster Presentation by Create Fertility Centre, London, 2017
- Generation of Monocyte Derived Dendritic Cells Using Xeno-Free Clinical Grade Human Platelet Lysate. ISCT Poster Presentation, Memphis, 2016
- Human Platelet Lysate (hPL) is Optimal for Expansion of First Trimester Human Umbilical Cord Perivascular Cells for Regenerative Medicine Applications. Canadian Fertility and Andrology Society Poster Presentation, Toronto, 2016
- Evaluation of Tissue Homogenization to Support the Generation of GMP-Compliant Mesenchymal Stromal Cells from the Umbilical Cord. Stem Cells International, vol. 2016, Article ID 3274054, 9 pages, 2016
- Human Platelet Lysate Produced at Industrial Scale for use as Fetal Bovine Serum Replacement in MSC Cell Therapies. MSC Poster Presentation, Cleveland, 2015
- Human Platelet Lysate Enhances Wound Healing. MHSRS Poster Presentation, Ft. Lauderdale, 2015
- Human Platelet Lysate Produced at Industrial Scale for Use as Fetal Bovine Serum Replacement in Cell Manufacturing Protocols. ISCT Poster Presentation, Las Vegas, 2015
- Human Platelet Lysate as a Cell Culture Media Supplement in Conjunction with a Cryoprecipitate-Coated Bioreactor for the Expansion of Human Mesenchymal Stem Cells in the Quantum System. ISSCR Poster Presentation by Terumo BCT, Vancouver, 2014
- Clinical-Grade Human Platelet Lysate Produced at Industrial Scale for Isolation, Expansion, and Cryopreservation of Mesenchymal Stromal Cells. ISSCR Poster Presentation, Vancouver, 2014
- Phenotypical and functional characteristics of mesenchymal stem cells from bone marrow: comparison of culture using different media supplemented with human platelet lysate or fetal bovine serum. Stem Cell Res Ther. 3(1); 6 (2012)
- Human platelet lysate can replace fetal bovine serum for clinical-scale expansion of functional mesenchymal stromal cells. Transfusion. 24(8); 1436-1446 (2007)
- Human Alternatives to Fetal Bovine Serum for the Expansion of Mesenchymal Stromal Cells from Bone Marrow. Stem Cells. 27(9); 2331-41 (2009)
