Search results for "filtration"
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Selecting a Comprehensive Bioburden Reduction Plan
Filtration
BioPharm: How do endemic bacteria affect the type of filter needed for filtration?
Mittelman and Anicetti (PDA task force): While bacteria (and fungi) may be present in all in-proce…
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Ensuring Viral Safety of Viral Vaccines and Vectors
Options include high temperature/short time (HTST), C spectrum ultraviolet light (UV-C), gamma irradiation, and nano- or virus filtration.
HTST is commonly used in the food and beverage industr…
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Selecting the Right Viral Clearance Technology
Ideally, methods from the first category, which include inactivation mechanisms such as low pH, detergent, or temperature hold steps and robust removal steps, such as virus filtration that clear a bro…
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Viral Clearance Challenges in Bioprocessing
In addition to treatment with heat and ultraviolet radiation, virus retentive filtration is recognized as one of the most efficient and robust virus removal steps, and implementation in the media feed…
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Challenges of Protein Aggregation During Purification
“All unit operations including chromatography, viral inactivation, viral filtration, and other filtration modes can create conditions that lead to protein aggregation, including shifts in pH and condu…
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QbD and PAT in Upstream and Downstream Processing
Pressure and filter volume represent CPPs for viral filtration steps. Again, if engineering controls permit tight control of these parameters, some may be downgraded to a lower parameter designation. …
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Concentration and Buffer Exchange Using the Automated, Single-Use ÄKTA™ readyflux System
Protein recovery was ≥ 99%, after 5‑times concentration and 5‑fold diafiltration. The process was performed according to set specifications for a tangential flow filtration (TFF) process, with the…
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Best Practices in Qualification of Single-Use Systems
Single-use buffer filtration system and storage bag application is common in downstream processes. Final drug-product sterile filtration and transfer using SUS has also being increasingly applied to f…
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Using Single-Use Technologies in Downstream Processing
Some examples are filtration systems, buffer preparation systems, and sampling/dispensing systems. Key advantages of using single-use systems are speed of implementation, which is crucial for high-imp…
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Trends in Downstream Bioprocessing
It involves the removal of insoluble cell debris and particulates; product isolation through extraction, adsorption, ultrafiltration, or precipitation; product purification through affinity chromatogr…