Search results for " detection" in Articles / App Notes
Article
Biopharma Advances Demand Specialized Expertise
Jun 15, 2015
By BioPharm International Editors
BioPharm International eBooks
Volume 28, Issue 13
Contract service providers share insights on biopharma market developments and the impl…
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
Apr 02, 2015
By Jill Wechsler
Pharmaceutical Technology
Volume 39, Issue 4
To ensure patient access to high quality, safe, and effective medicines, FDA spends considerable time and resou…
Article
FDA Approves First Biosimilar
Mar 06, 2015
By Randi Hernandez
BioPharm International
FDA approved Sandoz’s Zarxio (filgrastim-sndz) on March 6, 2015. The approval is a groundbreaking decision, as Sandoz is the firs…
Article
Securing the Single-Use Supply Chain
Dual sourcing is one of many possible solutions to securing the supply chain.
Single-use systems (SUS) have become established in biopharmaceutical drug development. As confidence in the technol…
Article
Viral Clearance Challenges in Bioprocessing
Challenges remain for virus removal and validation.
Nov 1, 2014
By: Cynthia Challener, PhD
BioPharm International
Volume 11, Issue 27, pp. 42-44
Removal and inactivation of adventitio…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
Three distinct focus areas were examined: (1) sample and standard preparation; (2) chromatographic separation; and (3) detection and data processing. Method variables were scored based on their potent…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Low energy (for peptide molecular weight) and high energy (for sequence assessment) mass spectrometric detection of the peptides during elution allow a further two dimensions of analysis. The data pro…
Article
Analyzing Proteins Using SEC, MALS, and UHPLC
“Integration reduces the distances between the detector cells and minimizes temperature variations experienced by the sample, which improves the separation performance, and thus detection and characte…
Article
Challenges in Analytical Method Development and Validation
…ters that should be evaluated during method development, including specificity, linearity, limits of detection (LOD) and quantitation limits (LOQ), range, accuracy, and precision. The robustness of m…
Article
Design of Experiments for Analytical Method Development and Validation
…t and identify factors that may influence precision, accuracy, linearity, signal to noise, limits of detection and quantification, and/or any other assay attributes to achieve optimal assay results. …