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Understanding the Options

Microbial Cell Culture Clarification: Protein Refold Pool Clarification



Clarification

Essential Process Requirements
  • Removal of haze formed during refold process after product protein solubilization
  • Mostly small sub-micron particles
  • Some fluid variability depending on refold process conditions

Recommended FilterFilter Characteristics

Triple-layer Millistak+ HC Filters
(Grade A1HC or B1HC)
Disc Filters
Pod Filters
  • Triple-layer configuration includes a membrane bottom layer to enhance filter loading capacity and retention
  • Higher filtrate quality allows smaller size requirements for downstream sterilizing-grade filtration step
  • Unique design enables the compression of multiple process steps into one, lowering overall filtration costs
  • The selection of Grade A1HC or B1HC depends on the fluid particle size distribution and should be based on small-scale testing


Sterile Filtration: Bioburden Reduction


Recommended FilterFilter Characteristics

Single-layer Durapore
0.22 µm PVDF Filters
Cartridge Filters
Optiseal Cartridge Filters
Opticap Capsule Filters
Optiseal Capsule Fitlers
  • Sterilizing-grade PVDF membrane won’t bind valuable protein
  • 100% Integrity tested to ensure proven performance
  • Can be integrity testable on-site
  • Although 0.22 µm is typical for this application, Durapore filters are available in several pore sizes and, in single-layer or multi-layer configurations to accommodate the needs of each user, the degree of protection required for the downstream process and the plugging characteristics of the fluid. Choice should be based on small-scale testing.

Millipore Express SHC
0.5 µm + 0.2 µm PES Filters
Cartridge Filters
Opticap Capsules
Optiscale Capsules
  • Sterilizing-grade PES membrane providing broad chemical compatibility across a wide pH range (1–14)
  • Robust construction validated for multiple SIP cycles
  • 100% integrity tested to ensure quality
  • Asymmetric pore structure delivers extremely high flow rates at low pressure drop
  • Can be integrity tested on-site
  • Although double-layer 0.5 µm + 0.2 µm (SHC) is typical for this application, single-layer 0.2 µm (SHF) is also available. The degree of protection required for the downstream process and the plugging characteristics of the fluid will guide this selection. Choice should be based on small-scale testing.