FAQ

Q.

Is PRIME-XV® MSC Expansion SFM serum-free, animal-component-free?

A.

PRIME-XV MSC Expansion SFM is serum-free. However, it is not animal-component-free.

Q.

Can I use the PRIME-XV® MSC Expansion SFM to culture cells without a coating substrate?

A.

No, it is not recommended. Unlike serum-containing MSC culture medium, serum-free culture condition for human MSCs requires fibronectin (such as PRIME-XV Human Fibronectin, Catalog # 31002) or our proprietary matrix protein (PRIME-XV MatrIS F, Catalog # 31001). Without a coating substrate, MSCs will die in absence of serum.

Q.

What are the advantages of PRIME-XV® MSC Expansion SFM?

A.

PRIME-XV MSC Expansion SFM outperforms leading competitors in cell expansion studies while maintaining MSC gross morphology, cell surface expression markers, multipotency potential and immune modulation abilities. Additionally, PRIME-XV MSC Expansion SFM has been tested to support optimal cell expansion of different sources of MSCs, including bone marrow-derived and adipose-derived MSCs. Little to no adaptation is required when shifting from a serum-containing medium to our medium. PRIME-XV MSC Expansion SFM is ready-to-use with no additional growth supplements required and is supplied in a convenient one 250mL complete component.

Q.

Why switch over from existing products or serum-containing medium?

A.

Our medium has been shown to outperform 10% serum-containing medium and leading competitors in human MSC cell expansion studies. Cell growth is more optimal in our medium, without compromising its immune modulation functions or phenotypic characteristics. Therefore, end-users will spend fewer resources (culture medium, labor, plastic-ware, and ancillary reagents) to culture MSCs. PRIME-XV® MSC Expansion SFM does not contain serum. This eliminates the lot-to-lot variability often associated with serum.

Q.

What are the main components in PRIME-XV® Hypothermic Preservation Solution and PRIME-XV Cryogenic Preservation Solution?

A.

Both PRIME-XV Hypothermic Preservation Solution and PRIME-XV Cryogenic Preservation Solution formulations are proprietary. However, they are serum-free, protein-free aqueous solutions containing various sugars, salts and buffers to provide optimal pH buffering. PRIME-XV Cryogenic Preservation Solution also contains 10% DMSO. All raw material components are USP/ multi-compendial or highest available grade, including water for injection (WFI) quality water and were made under GMP condition.

Q.

Is it normal to see precipitation in the PRIME-XV® MSC Expansion SFM?

A.

As human source material is present in the product it may develop some precipitate matter during storage. It is suggested to remove the precipitates from the media through filtration or centrifugation at 1500 rpm for 5 minutes after thawing the media. This filtration step does not affect product performance.

Q.

Why do we see a 400-fold expansion for adipose-derived MSCs while there is only an 18-fold increased for bone marrow-derived MSCs when using PRIME-XV® MSC Expansion SFM?

A.

MSCs derived from different sources, i.e. the origin of where the cells were isolated from, have different intrinsic growth rate. Regardless of the MSC sources, both populations of cells showed higher expansion rates in PRIME-XV MSC EXPANSION SFM when compared to 10% serum-containing medium.

Q.

What does xeno-free mean?

A.

A xeno-free product contains no animal-derived component but may potentially contain human-derived components.

Q.

What does animal component-free mean?

A.

An animal component-free product contains neither animal nor human-derived materials.

Q.

How often are MSCs passaged when cultured in PRIME-XV® MSC Expansion SFM?

A.

Cells are often passaged when they reach 80% confluency, or the coverage of the culture vessel by the cells. One hundred percent confluency refers to cells covering 100% of the cultured surface area. Time between each passage depends on the media performance and initial seeding density. However, on average, human mesenchymal stem cells (MSCs) cultured in PRIME-XV MSC EXPANSION SFM is passaged every 3-4 days.

Q.

Can PRIME-XV® MSC Expansion SFM formula be customized according to the customer’s needs?

A.

Yes. We can modify our formula and create a custom batch. For more information, please email us at tmrequest@irvinesci.com.

Q.

Can I use the PRIME-XV® cell therapy products for clinical applications?

A.

Our PRIME-XV product line is intended for research use or for further manufacturing use only. PRIME-XV products are not for use in diagnostic procedures. The safety and efficacy of these products in diagnostic or other clinical uses has not been established. However, we are able to generate custom, clinical-grade culture media using our existing scalable industrial manufacturing capabilities. Please contact us directly at tmrequest@irvinesci.com for further inquiries.

Q.

Where can I find more information on which PRIME-XV® products have DMFs (Drug Master File)?

A.

Please contact us at tmrequest@irvinesci.com and reference the product name and catalog number for which you are inquiring about DMFs.