Search results for " BIA"

Article Using Quality by Design to Develop Robust Chromatographic Methods
Figure 2: Representation of the analytical target profile (ATP) for (a) assay and (b) purity determination of an example substance using the probability curve approach (grey parabolic curve) where bia

Article Establishing Acceptance Criteria for Analytical Methods
The following are three equations that show how the analytical method is always influencing the quantitation of drug substance/product (Equations 1–3): Product Mean = Sample Mean + Method Bia

Article Design of Experiments for Analytical Method Development and Validation
• Develop/define the reference standards for bias and accuracy studies. • Define the steps in the method and any associated documentation. • Determine the responses that are aligned to the pur…

Article Bucking the Trend
Such a system is unable to self-correct as the bias for conformity is difficult to eliminate. A troubling extension of this bias is that certain molecules are effectively killed if they do not fit the…

Article Robust Business Continuity Program Helps to Maintain Operations in the Face of Crisis
As we began 2020, no one could have foreseen that just a few weeks into the year, we would be facing a pandemic threatening unprecedented damage to human health and the world economy. Businesses are…

Article Cell-Culture Advances Test Bioreactor Performance Models
The evolution of cell-culture technology is driving the need for improvements in modeling solutions. By Cynthia A. Challener  Modeling and simulation are recognized to provide assistance i…

Article Emerging Therapies Test Existing Bioanalytical Methods
These parameters include intra- and inter-assay precision and accuracy, dilutional linearity/integrity, selectivity, and stability, with acceptance criteria of ± 20% bias and ≤ 20% coefficient of vari…

Article Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
…ocyte-colony stimulating factor (GCSF) to human CD114-R receptor (R&D systems) was determined by Biacore X100 plus biosensor (GE Healthcare). For GCSF-R affinity analysis, CD114-R receptor was immobi…

Article Reliability Rooms and the Move to Proactive Supply Chain Management
The RRs, for example, engage in monthly demand reviews to measure and monitor mean-absolute-percent error and bias to forecast. The company has also introduced a bias-tracking signal that effect…

Article Hybrid Bioprocessing: A Q&A with Andrew Sinclair
The bias is toward fed batch with membrane techniques being used to increase cell density. Reduced media pricing would shift the balance toward perfusion-based processes. The situation in downstrea…

Next Page