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Understanding the Options

Microbial Cell Culture Clarification - Inclusion Body (IB) Purification




Harvest/Clarification

Essential Process Requirements
  • Recovery of Inclusion Bodies post cell lysis and before solubilization step
  • Elimination of waste fluid in the filtrate
  • High solids content in feed stream, which makes centrifugation a viable technology option
  • Feed stream quality can vary depending on cell type and culture conditions

Recommended FilterFilter Characteristics
TFF with Microfiltration Membrane

Prostak Open-Channel
Modules with 0.22 µm or
0.1 µm Durapore Membrane
  • Open-channel design accommodates high loading capacity and retention for haze removal post refolding
  • High flux at low transmembrane pressure
  • Robust construction allows multiple use
  • Validated for multiple SIP cycles
  • Selection of 0.22 µm or 0.1 µm membrane depends on particle size distribution in feed solution. Choice should be based upon small-scale testing.

ALTERNATIVE: For small volumes with low cell densities, Pellicon V Screen Cassettes with 0.22 µm or 0.1 µm Durapore Membrane should be tested in your small-scale trials.


Sterile Filtration: Bioburden Reduction

Essential Process Requirements
  • Reduces bioburden
  • Protects downstream chromatography and UF/DF steps
  • Maintains yield of dilute protein and preserves purity
  • Sterilizing-grade filtration required

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.