The main products for bio- and production chromatography have been assigned
Bulk-Biological Master File (BB-MF) Numbers by the FDA (Food and Drug Administration).
Specifications and QA/QC procedures are filed as FDA Drug Master Files (DMF). This will
undoubtedly be invaluable in validation of a process in which Fractogel® EMD media are used.
The following BB-MF Numbers are available and certain documents can be handed out to the
customer who is setting up production. However, a confidential disclosure agreement (CDA)
has to be signed.
BB-MF File Numbers
FDA Registration numbers of Fractogel® media
| Product |
EMD No. |
BB-MF No. |
| Fractogel® EMD TMAE S, M, Hicap |
16881, 16887, 10316 |
4140 |
| Fractogel® EMD SO3, S, M |
16882, 16890 |
4384 |
| Fractogel® EMD DEAE, S, M |
16883, 16888 |
4752 |
| Fractogel® EMD COO-, S, M |
16886, 16891 |
7193 |
| Fractogel® EMD BioSEC S |
10317 |
8114 |
| Fractogel® EMD DMAE S, M |
16889, 16884 |
8965 |
| Fractogel® EMD Chelate S, M |
16426, 10338 |
8254 |
|
|
