Upstream Bioprocessing
This phase involves all preparatory steps to set up the biological system for production or manufacturing.
Cell line/Strain Development: Selection or engineering of microorganisms, cell lines, enzymes to produce the desired target product.
Media Preparation: Formulation of a unique growth medium capable of supporting a specific cell type.
Cell Cultivation: Growing the selected cells or organisms in controlled conditions (e.g., temperature, pH, and oxygen levels) in flasks or bioreactors.
Inoculation and Scale-Up: The inoculation step in upstream bioprocessing is a critical phase where desired cells or microorganisms are introduced into prepared media, setting the foundation for their growth and subsequent scaling up to the bioreactor.
Fermentation/Bioreaction
This is the central phase where the biological system produces the desired product on a scale.
Bioreactor Operation: Large-scale culture of the biological system in bioreactors, maintaining optimal conditions (e.g., aeration, agitation, and nutrient feeding).
Product Monitoring: Real-time monitoring of growth, substrate utilization, and product formation.
Downstream Bioprocessing
This phase focuses on harvesting, purifying, and formulating the product.
Harvesting: Separating cells or supernatants depending on whether the product is intracellular or extracellular
Purification: Isolating the product using techniques such as:
- Filtration or centrifugation (for bulk separation)
- Chromatography or precipitation (for specific purification)
- Ultrafiltration or dialysis (for concentration and buffer exchange)
Formulation and Fill-Finish
- Adding stabilizers or excipients
- Packaging in vials, syringes, or bulk containers
The production and purification of the target biological products rely heavily on buffers and solutions to regulate pH and stabilize biochemical reactions during all stages of bioprocessing.
Understanding where buffers are used helps guide proper selection:
