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General Questions

We were the FIRST human platelet lysate on the market, we have treated the most, and we are solely dedicated to providing clinical researchers with the BEST platelet derived media supplement available.

We are dedicated to quality. We are a small company and want to partner with you to help your trial to succeed.

We make our human platelet lysate (hPL) from human platelets. These platelets are ones that were intended for use in humans in hospitals and clinics, but expired, since platelets only last several days.

The platelets have been tested and approved for human use by United States AABB, FDA certified blood banks.

Mill Creek hPL reagents can be used for ex vivo cell culture applications. Our products are sold, and intended for use, as ancillary materials for cell, gene, and tissue-engineered products (USP <1043>).

Mill Creek hPL reagents are not intended for direct administration, injection, or infusion into humans.

Regulatory Questions

Our roots are cGMP processing and we are certified to ISO 9001:2015. We have been site audited multiple times by some of the best commercial processors in the business.

Site visit or send us a questionnaire and we will answer you promptly.

Mill Creek hPL reagents are manufactured and tested under a quality management system (ISO 9001) and are in compliance with the relevant cGMP guidelines.

They are designed following the recommendations of USP <1043> ancillary materials for cell, gene, and tissue-engineered products. Our products are generally compliant with European Pharmacopoeia 5.2.12 and 5.1.7.

Yes, we have a type II master file with FDA CBER. All of our hPL products are covered under Mill Creek's Master File (MF), which is referenceable with the FDA upon request (request a Letter of Authorization from us).

Master File#: CBER MF 16784. Holder: Mill Creek Life Sciences, Inc. Subject (Title): Human Platelet Lysate Reagents.

If you are looking for our Master File on this list (https://www.fda.gov/drugs/drug-master-files-dmfs/list-drug-master-files-dmfs), you will not find it, because that list is for FDA CDER, not CBER.

Mill Creek’s MF is filed with FDA Center for Biologics Evaluation and Research (CBER), rather than Center for Drug Evaluation and Research (CDER), because of the biological nature of the hPL reagents and because our customers/users are generally cell therapy developers, so the FDA reviewers reviewing the MF are from CBER. Our MF has been reviewed by CBER throughout IND submissions by our customers.

Additional information on our MF and LoA requests can be found here. Additional information on CBER Master Files can be found on FDA’s website.

Yes. Our products have been used in 50+ clinical trials all over the world including Phase I, II, and III as a cell culture supplement in cellular therapy.

Product Questions

All of our hPL products are manufactured with expired platelets from healthy donors from U.S. AABB certified blood banks. All donors passed FDA required testing at the time of donation. This product is available in research and clinical grade.

PLTMax® is our original hPL product. This product is an animal serum-free alternative, however, a small amount of heparin is added in the manufacturing process and while preparing the complete media to minimize coagulation.

PLTGold® is our heparin-free (100% xeno-free) hPL. PLTGold® is not fibrinogen depleted and it does not clot.

PLTMax®-GI and PLTGold®-GI (gamma irradiated) are regular PLTMax® and PLTGold® in which the final hPL product has been gamma-irradiated (25-38 kGy).

PLTGold® is completely xeno-free. No heparin is required (or used in manufacture) and you will get no clotting.

PLTMax® is not. We add a small amount of pharmaceutical grade heparin. Heparin is a widely prescribed and safe drug for direct injection in humans. We have not had any commentary from any regulatory agency suggesting that the addition of heparin is of any significant concern.

The research and clinical grades are manufactured exactly the same. The only difference between research and clinical is we don’t certify research grade for endotoxin on the CoA.

That way, we can offer our customers a lower priced product for process development and then they can switch to clinical grade for human trials without the need for equivalency testing. All of our products are produced under cGMP conditions.

PLTMax® and PLTGold® have a shelf life from date of manufacture of 5 years when stored at -20°C or colder (supported with real time stability data).

PLTMax®-GI and PLTGold®-GI currently have a shelf life of 3 years, which is anticipated to be extended with the support of real time testing.

Approximately 25L with more than 100 donors pooled.

None of our platelet lysates are fibrinogen depleted, which is unique compared to other hPLs. PLTMax® requires heparin but PLTGold® does not require heparin and does not clot.

See the below attached resources outlining the benefits of an hPL that is not fibrinogen depleted. 

View Mayo Clinic Poster Here

View Frontiers in Immunology Here

PLTMax® and PLTGold® are offered in a gamma irradiated version (PLTMax®-GI and PLTGold®-GI). They have been treated with 25-38 kGy of gamma radiation.

Mill Creek validated the gamma process with a 5-virus viral clearance study that demonstrated viral inactivation with each of the viruses.

Technical Questions

The fewer freeze/thaw cycles, the better. Our standard recommendation is to thaw the product and prepare aliquots as soon as it is received. Aliquots can be stored at -20°C or colder and then thawed again when ready for use. That recommendation consists of the initial thaw, freezing the aliquots, and then a second thaw when ready to use the aliquots.

We have done freeze/thaw cycle testing with our hPL and the product proves to be very stable. Even after 3 or 4 freeze/thaw cycles, the cell growth is not altered or affected. There is a gradual increase in turbidity and slight color change with more freeze/thaw cycles, but the product will still perform as expected.

We still recommend as few freeze/thaw cycles as possible.

Filtration of hPL by itself is not recommended. Filtration of complete media containing hPL may be performed, if necessary. Due to the nature of the product as a highly proteinaceous biologic derived from human platelets, there can be variability from donors (even when we pool many donors in a single lot) that can affect flow rate when filtering and at times it can be difficult to filter media containing hPL.

Filtration ability can also vary lot to lot. Product performance is not affected by ability to filter, and we see very similar performance when comparing filtering or non-filtering complete media.

We recommend using a low protein binding PES filter. You can also try a serial filtration doing 0.45μm filter and then 0.2μm filter.

Thaw at 37°C or 4°C. It is not recommended to expose hPL to repeated temperature changes that could affect the integrity of its components. For that reason, we recommend thawing the product and preparing aliquots as soon as it is received.

Aliquots can be stored at -20°C or colder protected from light. Storage at 4°C is recommended for periods no longer than 2 weeks.

Yes! They work great for both, as well as other primary cells.

Contact us for more information dependent on your specific application.

Our human platelet lysate products are used with MSCs, T Cells, NK Cells, Tumor Cells, Endothelial cells, iPSCs, and many more.

Standard protocols suggest 5% vol/vol. We have had great luck at that concentration.

There is one big difference between our hPLs and FBS: You CAN use too much PLTMax® or PLTGold®. It will slow growth of MSCs at high concentrations. But feel free to titrate it to maximize the growth of your cells (typically between 2-10%). We have reports of different concentrations required with different base medias and different cells.

PLTMax® stored at 4C can spontaneously develop precipitates over time. DON’T WORRY.

These are clot like segments from the clotting factors present in human platelets. They have no effect on PLTMax® function. We just pipette around them and suggest you should too.

PLTMax® retains many of the clotting factors found in raw platelets. Under certain conditions, it can stimulate a clot-like reaction in cell culture media. Adding the heparin minimizes this. So, add the heparin to the media before you add PLTMax®.

If you require a heparin-free hPL, try out PLTGold®!

No! PLTGold® was developed as an alternative to PLTMax®, to be a 100% xeno-free, heparin-free, and clot-free human platelet lysate. It does not contain heparin and you should not add heparin to the complete media.