Bambanker™ hRM Now Has a US Type II Drug Master File
We’re pleased to share some news from our manufacturer, Nippon Genetics. Bambanker™ hRM Serum-Free Cell Freezing Media is now supported by a Type II Drug Master File (DMF) with the US FDA.
For anyone working towards clinical or translational applications, this matters. A DMF holds confidential manufacturing and quality information about a material, so you don’t have to submit it yourself. With the manufacturer’s authorisation, your own regulatory submission can reference the file directly. That can save a lot of back and forth when you’re documenting the freezing medium used in a stem cell workflow.
Bambanker™ hRM is a chemically defined, xeno-free formulation made with Human Serum Albumin and free from bovine or other animal-derived components. It’s optimised for primate ES and iPS cells, and it maintains pluripotency after thawing. Like the rest of the range, it goes straight into a -80°C freezer, so there’s no programmable freezer or liquid nitrogen step for the initial freeze.
If you’d like to reference the DMF in a submission, get in touch and we’ll put you in touch with the right people to arrange authorisation.
Why researchers choose Bambanker™
Bambanker™ has become one of our best-selling cell freezing media because it takes the fiddly parts out of cell banking:
- No controlled-rate freezing. Resuspend your cells, put the vial in a -80°C freezer and that’s it.
- Long-term storage at -80°C. It’s validated for up to 5 years, which reduces your dependence on liquid nitrogen.
- High viability. The serum-free, defined composition keeps variability low, with recovery above 95% for many cell types.
- Broad compatibility. It’s been validated on over 1,000 cell lines, including hybridomas, stem cells and primary isolates.
- Ready to use. There’s no dilution and no DMSO to add.
The JCRB Cell Bank, which manages around 1,400 cell lines, tested Bambanker™ against its standard media on four hard-to-preserve lines and decided to switch.
Choosing the right Bambanker™
Every Bambanker™ medium is ready to use, free of fetal bovine serum and antibiotics, and freezes cells directly at -80°C. They differ in what they are built to protect.
| Catalogue No. | Product | Best for | Formulation | Freezing workflow | Pack sizes |
|---|---|---|---|---|---|
| K1-0666 K1-0664 K1-0662 K1-0661 |
 Bambanker™ (Standard)View Product |
Routine and primary cell lines, tissue pieces, organoids and spheroids | Serum-free, 10% DMSO | Pellet, resuspend, freeze at -80°C | 10 mL, 20 mL, 5 × 20 mL, 100 mL |
| K1-0668 |  Bambanker™ DirectView Product |
Hybridomas, fragile suspension cells, high-throughput clone banking | FBS-free (contains bovine serum-derived components) | Add 1:1 to cells in medium, freeze at -80°C. No centrifugation | 20 mL |
| K1-0676 |  Bambanker™ DMSO FreeView Product |
Cells that are damaged or differentiated by DMSO | Serum-free, DMSO-free | Pellet, resuspend, freeze at -80°C | 20 mL |
| K1-0672 K1-0673 |
 Bambanker™ hRMYou are here View Product |
Human and primate ES and iPS cells | Serum-free, xeno-free, human serum albumin, 10% DMSO. US Type II DMF | Pellet, resuspend, freeze at -80°C | 20 mL, 100 mL |
Bambanker™ hRM compared with other stem cell freezing methods
| Vitrification | 10% DMSO in culture medium | Bambanker™ hRM | |
|---|---|---|---|
| Technique | Demanding, fast handling in liquid nitrogen | Simple | Simple |
| Equipment | Liquid nitrogen at the point of freezing | Controlled cooling | -80°C freezer |
| Colony recovery in human iPSCs | Large colonies | Small colonies | Large colonies |
| Animal components | Depends on the solution | Depends on the medium | Xeno-free, human serum albumin |
| US FDA Drug Master File | Not applicable | Depends on the medium | Type II DMF on record |