White Paper: Biopharma Downstream Critical Process Parameters
Ready to Unlock the Secrets of Efficient Biopharma Downstream Processes?
For the first time, a single White Paper offers a comprehensive overview of key DSP unit operations, such as chromatography, ultrafiltration/diafiltration, viral inactivation, and optional operations like centrifugation and refolding.
Gain insights into designing efficient and robust DSP processes with cutting-edge sensing technology that guarantee product quality, safety, and efficacy in the biopharmaceutical downstream process.
Download our White Paper to learn about:
- The critical process parameters (CPPs) associated with each operation.
- The advanced analytical process sensors used for monitoring CPP's in the downstream process.
- The advantages and applications of reusable and single-use technologies.
In Biopharmaceutical Downstream Processing (DSP), Every Step Counts to Ensure Highest Product Quality
Buffer preparation
Buffer solutions, crucial for maintaining optimal pH and ionic strength in biopharmaceutical processes, must be carefully selected and prepared. The use of real-time monitoring technology is also integral for effective in-line measurements of pH and conductivity.
Purification: Chromatography
Chromatography is a post-bioreactor stage process used for separating target biomolecules from cellular debris and other impurities based on their distinctive physical and chemical properties. Techniques such as Protein A and Ion Exchange (IEX) chromatography aid in impurity removal, variant isolation, and buffer exchange. In-line monitoring of pH and conductivity is vital for successful purification.
Purification: Concentration and Filtration
Filtration units, which concentrate, purify, and perform buffer exchange on target biomolecules, typically follow the chromatography steps. Detailed explanations of Tangential Flow Filtration (TFF) principles and applications are provided, emphasizing the significance of choosing a suitable membrane with an appropriate Molecular Weight Cut-off (MWCO). The increasing utilization of single-use technology and the necessity to monitor parameters like pH, conductivity, flow, and pressure for efficient filtration are thoroughly discussed.
Viral Inactivation
Viral inactivation is essential, especially in the production of proteins and monoclonal antibodies derived from mammalian cell culture systems. The chapter highlights low pH treatment as a prevalent method of inactivation and underscores the importance of closely monitoring and controlling parameters such as pH, treatment duration, viral concentration, and temperature. The use and requirements of single-use and reusable equipment, in compliance with good manufacturing practices, are also discussed.
Centrifugation
Centrifugation is employed for activities like cell separation, clarification, and viral particle removal. It's vital to pay attention to critical process parameters and monitor factors like turbidity and dissolved oxygen to ensure process efficiency and product stability.
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