Process Buffers/Solutions for Bioprocessing
Bioprocessing is the use of biological systems such as living cells or enzymes to engineer cell therapies, gene therapies, and biologics including proteins and antibodies.Â
The major steps in bioprocessing workflow can be broadly categorized into three main phases: Upstream Processing, Fermentation/Bioreaction, and Downstream Processing. Â
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 relies heavily on buffers and solutions to regulate pH and stabilize biochemical reactions during all stages of bioprocessing.
| Features | Upstream / Bioreactor | Downstream | |
|---|---|---|---|
| Role of buffers/process solutions | Maintain optimal pH in cell culture systems, promoting cell growth and protein production while preserving the protein’s functionality during recovery | Buffers aid in extraction and purification of target molecules by supporting techniques like chromatography (ion exchange, reverse phase and affinity) and filtration | |
| Commonly used buffers/solutions |
Media Cell culture water Salt solutions Buffers to maintain pH Sterilization solutions (NaOH, 20% ethanol) Antifoam |
Lysis buffer Detergent Protease inhibitors Salt solutions Buffers to maintain pH |
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Partner with Boston BioProducts for Bioprocessing Solutions
At Boston BioProducts, we provide GMP-grade bioprocessing buffers manufactured under ISO 13485:2016 and 21 CFR part 820 guidelines, ensuring superior quality, process reliability, and scalability for large-scale production. Our versatile packaging solutions range from sterile bottles (100mL–5L) to bioprocess bags (1L–200L), offering flexibility while minimizing contamination risks with single-use sterile options.
We also offer custom buffer and media preparation services, collaborating closely to deliver tailored solutions for both upstream and downstream processes, ensuring seamless integration into your bioprocessing workflows. From regulatory documentation to ongoing qualification, we provide long-term support to ensure compliance and consistent performance throughout your product's lifecycle. Explore the bioprocessing buffers and solutions we offer here.