Frequently Asked Questions
1
Does Elk have a consistent supply of platelets?
Yes, our strong supply partnerships ensure ample hPL supply to meet large-scale commercialization needs.
2
Are platelet donors screened prior to use?
Yes. The human platelet lysates that we use are manufactured from apheresis platelet units sourced from FDA/AABB approved blood centers. Donors have been tested and found to be negative for communicable diseases including HIV I/II Antibody, HIV NAT, HTLV I/II Antibody, Hepatitis B Surface Antigen, Hepatitis B Core Antibody, Hepatitis C Virus Antibody, Hepatitis C NAT, and RPR for Syphilis.
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3
Is heparin already present in the bottle? Do I have to include it?
Heparin is not present in our hPL, and it is not required for use. Porcine heparin prevents clotting due to plasmatic coagulation factors. Since our hPL is processed to deplete fibrinogen, we minimize the possibility of further clotting.
4
What are freeze/thaw recommendations?
Although multiple freeze/thaw cycles do not harm our hPL
performance, we recommend limiting them to an absolute minimum. If not using the entire volume, upon initial thaw, aliquot into desired volumes and refreeze at -20ºC or -80ºC for long-term storage.
5
What are the typical concentrations for different cell types?
Data demonstrate that hPL is generally suitable at a lower concentration than FBS or AB Serum (between 2-10%), since it contains high concentrations of growth factors and cytokines.
6
Do you offer a Certificate of Analysis?
All Elk Bioscience products are supplied with a CoA upon purchase, providing all release criteria, data, and information.
7
Can we use your products for clinical trials?
Yes. We have a Drug Master File on record with the FDA that is referenceable. Our hPL has been used in many clinical trials.
8
How is hPL made?
Our hPL is made from expired human platelets that were intended for use in humans in hospitals and clinics.They have been tested and approved for human use by the FDA/AABB.
9
Why should we choose Elk?
At Elk Bioscience we are dedicated to serving those creating cell based therapies to heal and improve the lives of patients. Our hPL performs to improve cell manufacturing process and enhances the probability of successful therapies, while meeting regulatory expectations and offering outstanding quality at the best market price. We offer a consistent, reliable and commercially available hPL, delivered to you when needed the most.