During harvesting of cell cultures to extract extracellular proteins, clarification is required to remove cells, cell debris, and large protein aggregates from the culture media prior to sterile filtration and purification. If not removed, the phospholipid bilayer of cell membranes can cause issues during downstream purification steps, decreasing the quality and quantity of protein products. Separation through centrifugation can be cumbersome for large volumes. Additionally, poorly clarified solutions can cause clogging during sterile filtration,
slowing workflow. The use of small-pore filters during clarification and prior to sterilization can lead to cost reduction and improved product recovery. Establishing the strongest performing harvest process with the best fit technology for a specific cell culture early in monoclonal antibody (mAb) process development is essential. Scalability of the chosen technology is key for a seamless transition from small volumes to liters with minimal changes in process operation to ensure expected reproducible outcomes.
Pall Laboratory offers a range of depth filtration capsules with stacked and integrated high-performance depth media, designed to efficiently remove particulate contamination and clarify solutions prior to downstream processing. Depth filtration efficiently processes concentrated solutions with high cell counts such as cell cultures and fermentation broths. A third dimension, thickness, is added to the filter structure effectively trapping particulate matter, both at the surface and throughout the depth of the entire filter media. The correct choice of filter type allows for removal of cells of differing sizes (e.g. bacteria, yeast, and mammalian cells), and clarification of cell debris or cell lysate. Our Supracap™ Depth Filter Capsules are optimized for biological and pharmaceutical requirements and are scalable for GMP production requirements and size. Pall has designed a system for clarifying cell culture media that is well suited for monoclonal antibody (mAb) production that places a PDP8 Supracap filter in series with a PDE2 Supracap filter, the same configuration as Pall Stax™ mAx Clarification Platform that can handle hundreds of liters of media at a time.
