Step 7: Harvesting
Fast and Consistent
Predictable Clarification with Dynamic Bodyfeed Technology
The Sartoclear product family addresses a well identified need in the biopharmaceutical industry for cell harvest. Sartoclear Dynamics® is a new single-use technology for harvesting animal cell cultures with high cell densities. Consistent results, ease of use, enormous speed and flexible scalability are the key characteristics of this technology. Inspired by the plasma industry, Sartoclear Dynamics® is based on the principles of body feed filtration. The ready-to-use clarification system enables single-use processing up to 2,000 liters. As a result, it replaces centrifuges and the subsequent depth filters in a single step.
Replace your Centrifuge with Sartoclear Dynamics
Single-Use Harvesting of Cell Cultures up to 15% Biomass
Sartoclear Dynamics enables single-use harvesting of concentrated cultures of up to 15% biomass in a single step. Single-use bioreactors up to 2000 liters can be harvested without using a stainless steel centrifuge, which saves valuable time during the development stages of molecules. The technology is insensitive to variable cell viabilities which enables a fast and robust process development. These characteristics make this technology the best choice from early development up to 2000 L commercial manufacturing.
The Reality Check
A large variety of different cell cultures were tested to find the best harvesting conditions for Sartoclear Dynamics® filters. The optimal conditions appeared to be similar for most cell lines. It was proven that the required amount of Diatomaceous Earth is relative to the amount of biomass in the culture. Further, it appeared that an acid precipitation of the smallest particles positively impacts the performance of the technology. The optimal conditions could be confirmed in a 1,000 L test which is described below.
Unmatched Clarification Capacity
Choose the Most Robust, Proven 0.2 μm Sartopore Filter for Harvest Bioburden Reduction
Sartopore® 2 XLG 0.8/0.2 μm filter is the ideal choice for pre-clarified harvest. Enjoy the reliable performance and the lowest cost of filtration with exceptional throughput over a wide range of molecules.
High-Cell–Density Clarification by Single-Use Diatomaceous Earth Filtration
Processes with a demanding character (e.g., high cell densities, high titers, high turbidities, increased particle/contaminant loads) especially can bring disposables to their technical limits, especially in product harvesting. Here we focus on that step, which is defined as a removal of cells, debris, and (ideally) typical contaminants such as host-cell proteins (HCPs) and DNA from process fluid.