Search results for " process" in Articles / App Notes
Article
Challenges in Analytical Method Development and Validation
Alice Krumenaker, manager, QC Stability Administration, at West-Ward Pharmaceuticals, suggests that an analytical method may need to be modified and/or updated during the drug-development process to m…
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2019’s Top Bioprocessing Trends and What to Expect in 2020
In 2019, a novel production process for adenovirus vectors—used in cancer gene therapy trials and evaluated for use in vaccines—got attention for its technical and process economic advantages compared…
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A Look at the Affinity Chromatography Landscape
Beyond impurity removal for “simple” proteins
Affinity chromatography in biologics manufacturing has typically served as a method for removal of process-related impurities such as host-cell protei…
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A Plastic Pipeline for Commercial Bioprocessing?
Adoption for commercial production has been slow; however, as more therapies developed under single-use processes move toward regulatory approval, industry experts expect the percentage of biologic-ba…
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Avoiding Investigational Failures and Discrepancies
Historically, corrective actions and preventive actions (CAPAs) have been overused industry-wide as a part of the investigation process within the overall quality event management scheme. Even industr…
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Ensuring Sterility in Small-Scale Production
In fact, some of the batches might be manufactured under a laminar flow hood by manual aseptic processing. It is important to remember that sterility assurance of the product must be maintained even w…
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Implications of Cell Culture Conditions on Protein Glycosylation
It is a complex process that consists of the attachment of carbohydrate moieties, with possible attachment sites via asparagine (N-linkage) or serine/threonine (O-linkage) amino acids in protein struc…
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Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Important manufacturing CQAs related to protein integrity, homogeneity, presence of host-cell proteins, host-cell DNA, and/or substances released from process or package material, can be identified us…
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Breakthrough Drugs Raise Development and Production Challenges
…s for assessing breakthrough designation requests and for expediting reviews of these drugs, but the process is resource intensive and has raised questions about how FDA can keep up with a growing nu…
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Re-use of Protein A Resin: Fouling and Economics
Thus, Protein A is considered to be the most crucial step in the purification process and a major contributor towards achieving the stringent purity levels expected of biotech therapeutics with HCPs r…