A serum-free medium (SFM) for cell culture that would greatly reduce the risk of viral or prion contamination by eliminating all components of animal or human origin has also been demonstrated to support virus growth equivalent to titers seen with serum supplemented media.
Upstream Cell Culture Manufacturing - Reduce cost, increase quality, an shorten cycle time with the DHX Heat Exchanger
Downstream Protein Purification - Integrate sterile and efficient temperature control with the DHX Heat Exchanger
Real-time release testing can be defined as a set of in-process controls that may provide greater assurance of product quality than end-product testing.
Real-time data on the biomass is essential to implement advanced control strategies, including the control of biomass-specific nutrient uptake rates.
Higher throughput in downstream processing is leading to the adoption of more efficient multi-column continuous counter-current chromatography systems capable of significantly reducing consumable cost.
Due to numerous benefits, including flexibility, absence of cross contamination, and elimination of cleaning validation, single-use technology is being widely adopted by the biopharmaceutical industry, even in very critical applications, such as formulation and filling. In these applications, the drug product is typically high value and/or highly potent. Typically, a strong Quality by Design (QbD) approach is in place and several tests are performed during single-use systems manufacturing. However, end users also need to mitigate any risk of product loss or operator exposure due to the potential risk of a single-use system leaking during drug product processing.
This report gives a guideline on the approximate pressures and drying times required to dry Pall hydrophobic membrane filters.
In many applications, the iCELLis Nano bioreactor is used as a development tool for large scale production processes. One of the important parameters for the scale-up of the iCELLis Nano bioreactor is the liquid linear velocity through the fixed-bed (located in the central column). This flow rate directly affects the cell dispersion through the fixed-bed and the shear stress on the cells.
This Application Note explains the rationale behind the scale-up principles and demonstrates through an applied case-study using Vero cell line that the scale-up from bench to manufacturing scale can be performed successfully from a 1.6 m2 surface bioreactor (4 L culture) to 200 m2 bioreactor (500 L culture) in a single step.
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