Search results for " filtration"
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A risk based approach to sterile filtration
Drug quality cannot be assured only by finished-product testing. Process validation is required to establish scientific evidence that a process is capable of delivering an e:ffective and safe …
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Challenges in Cell Harvesting Prompt Enhancements
Cell harvesting involves the separation of the cell-culture from the medium and running it through several techniques: centrifugation, microfiltration, depth filtration, and filtration through absolut…
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Downstream Processing for Cell-Based Therapies
Typically, a swing-bucket rotor centrifugation step or a filtration step is included to remove cell debris, large aggregates, unwanted proteins, volume reduce (i.e., concentrate), and formulate the ce…
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Updating Viral Clearance for New Biologic Modalities
Because viruses are typically smaller than downstream impurities such as host cell proteins (HCPs) and other extracellular debris, they require meticulous filtration, even in more established processe…
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Downstream Processing Continues to Worry CMOs
One such step is depth filtration, which has also declined in its own right as a contributor to capacity constraints. This year, 8% of respondents reported at least “significant” constraints due to de…
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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…