3M delivers early purification with new hybrid purifiers


Single-use functionalised media provides scalable purification performance in cell culture

3M's Emphaze AEX Hybrid Purifier encapsulates an anionic exchange (AEX) media with a downstream micro-porous membrane for single-use manufacturing.

The scalable range is suitable for process development through to large scale cell culture.

The firm says Emphaze AEX Hybrid Purifiers address the requirement for high purity as early as possible in the manufacturing process. Using anionic ligand technology, the purifier delivers chromatographic adsorption capabilities to reduce soluble and insoluble contaminants that are typically removed by Protein A columns and subsequent purification stages such as host cell proteins (HCP), host cell DNA and endotoxin. Rapid pressure build on the 0.2um bioburden membrane downstream of the functionalised media signals when ion exchange capacity is saturated, helping to protect against breakthrough of impurities. Early removal of soluble impurities will lessen the impact on expensive downstream purification technologies such as the Protein A column.

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The new purifiers are said to be easy to use, scalable and offer reproducible performance as there is no scope for channelling or mixing as seen with mobile media. The range is fully disposable eliminating the need for cleaning validation and can be retrofitted into existing hardware platforms.