Immunotherapy Workflow - Step 5. Cell Harvesting & Formulation 

Cell Harvesting eliminates old cell culture medium, washes, tests and concentrates cells.
In order to enable cells be available as products, formulation is critical in terms of stabilization of molecules or cells to achieve practical shelf life, storage and handling conditions.

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cell harvesting & formulation

​Your challenges

  • ​How do you minimize Shearing effects and heavy impact on viability during cell harvesting?
  • How to maintain Biological Integrity? Robust, safe and reliable solution for easy aseptic manipulations of mammalian cells (including during viral or pathogen steps).
  • Is your cell counting and viability analysis method automated, easy and reliable? Can you answer data integrity questions from auditors?

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Definitions

Cell harvesting

Cell harvesting is an important processes in nearly all downstream purifications of biotech-based products. When the product is internal to the cells, cell harvesting is used to decrease the liquid volume of cells to be processed in the product extraction steps. Available methods for cell harvesting include TFF (Tangential Flow Filtration) and the combination of Centrifugation with depth filtration.
 

Formulation

Each of the several steps of synthesis and operation require specific environments for the cells which expose them to different compositions in the formulation. Similar to other biopharmaceutical products, cells need ancillary materials to provide necessities for stability, including non-oxidative/reducing environment, proper pH, and other critical factors. However, unlike biologics, cell-based products also need nutritional components to keep them alive and to maintain robust metabolism as well as cryoprotectant agents (CPA) to protect them from the stresses caused by dramatic temperature fluctuations during their processing. 


Sources:

Zhang, Y., Williams Iii, R. O., & Tucker, H. O. (2020). Formulation strategies in immunotherapeutic pharmaceutical products. World journal of clinical oncology, 11(5), 275–282. https://doi.org/10.5306/wjco.v11.i5.275