Downstream Protein Purification Technical Note

Downstream Protein Purification - Integrate sterile and efficient temperature control with the Thermo Scientific DHX Heat Exchanger

Bio-therapeutic manufacturing requires precise control of process parameters throughout production to ensure high yield and high quality products that are safe for patient use. The pressure on manufacturing facilities to increase yields, decrease turnaround time and reduce cost has never been greater than it is today, and presents a challenge that users must deal with on a day-to-day basis.

Downstream processing, specifically downstream protein purification is the final stage in bio-therapeutic manufacturing; the point when the target protein is harvested and purified. Single-use technologies have found their place during downstream protein purification providing a sterile processing environment without the cost and time of clean in place or steam in place sterilization (CIP/SIP). although users are typically most concerned about bioburden control rather than sterility until the viral filtration step, the FDA still mandates sanitization standards that must be met. Single-use technologies are a practical solution to meet these standards, decrease costs, reduce contamination risk, increase process speed and turnover between processes.