Search results for " safety" in Articles / App Notes
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
However, even when defined as critical, not all CQAs have equal impact on safety and effectiveness (3, 5).
The definition for CPP states that a parameter is considered critical when its variabi…
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Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
The conclusion was that the prion reduction capacity of existing steps in the manufacturing purification processes should be considered as a major risk reduction factor with respect to the safety of p…
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Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
Many powders have properties that cause them to clump or cause static holdup, increasing the labor required per batch and the risk of potential safety incidents.
Solid agglomerates …
Article
The Importance of Partnering for Bioanalytical Studies
Bioanalytical work serves to supplement pivotal studies and aid in the decision-making process for approval, safety, and/or labeling of a drug or biologic; in short, without proper bioanalytical data,…
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Leveraging Computational Models of Glycosylation for Biopharma QA
Due to its bioprocess-associated variability and impact on safety, pharmacokinetics, and pharmacodynamics, glycosylation is widely regarded as a critical quality attribute (CQA) of TGPs (1).
In th…
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Establishment of New Modern Plasma Fractionation Facilities in Asia
…gher yields, a more diversified product range, and, most importantly, a significantly enhanced viral safety profile. The result of these activities has created a dynamic and robust industry that curr…
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Understanding Validation and Technical Transfer, Part I
Therefore, the manufacturing and purification processes become critically important in ensuring the “sameness,” quality, efficacy, and safety of these products.
Process validation is documented…
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Applying GMPs in Stages of Development
It is important to keep in mind that change control and deviations are critical elements for ensuring product quality and patient safety regardless of the stage of development a product is at in the p…
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ADC Development Robust Despite Lackluster Performance
Soon after its first approval by FDA in 2000, Pfizer voluntarily withdrew Mylotarg from the market because the company was unable to verify a clinical benefit and because of safety concerns. The more …
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Managing Residual Impurities During Downstream Processing
Increased understanding of potential impurities and their consequence to the ultimate quality, safety, and efficacy of biopharmaceuticals--as well as improvements in analytical technology that provide…