Search results for " viral clearance"
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Development of Purification for Challenging Fc-Fusion Proteins
As tested on three Fc-fusion proteins, this process demonstrates high process yield, improved clearance of HMWs and LMWs, and efficient reduction of host cell proteins (HCP) and DNA as well as robust …
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Addressing the Complex Nature of Downstream Processing with QbD
QbD in viral clearance
Viral clearance is connected to patient safety, according to Malmquist. During downstream processing, virus inactivation, virus filtration, and chromatography steps are perf…
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Emerging Therapies Test Existing Bioanalytical Methods
Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex thera…
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The Development and Application of a Monoclonal Antibody Purification Platform
…ffected by increasing cell culture titers and subsequent changes in the impurity profile, as well as viral clearance issues. The platform was developed to maximize the efficiency of the purification …
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Report from the 6th International HTPD Conference
Indeed, viral clearance studies are important, but costly and time-consuming tasks in downstream process development. Today, virus surrogates are being used more and more, yet if mechanistic modeling …
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Case Study: Virus Reduction of an Affinity Capture Step
Evaluating how much a process step contributes to viral clearance is an essential part of process validation. For this reason, there is an industry need to perform effective viral clearance studies. I…
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Microbiological Testing: Time is of the Essence
Results of the tests performed on diluted samples can also be supported by viral clearance data generated during process development.
For biopharmaceutical manufacturers including contract manufact…
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Going Small to Achieve Success on the Commercial Scale
…ed to determine optimum conditions for downstream separation processes, including chromatography and viral clearance steps. Qualification that such models provide results truly representative of comm…
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Evolution of the Monoclonal Antibody Purification Platform
The authors discuss the evolution of the purification platform for manufacturing of mAb therapeutics.
Monoclonal antibodies (mAb) increasingly form the majority share of the product pipeline…
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Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Examples of the viral clearance methods being implemented with increasing frequency fall into three categories:
• Inactivation—Includes methods such as high-temperature short-time (HTST), ul…