Search results for " purity"
Article
Use of Multivariate Data Analysis in Bioprocessing
Apr 06, 2015
By Anurag S. Rathore, Sumit K. Singh
BioPharm International
The ever increasing demand of biotherapeutics, together with the pressure to contain healthcare costs have motiva…
Article
Ensuring the Quality of Biologicals
monographs and general chapters for biologicals make reference to the use of chemical reference standards and biological reference preparations (BRPs) for identification, purity testing, and assay (co…
Article
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…
Article
Continuous Manufacturing: A Changing Processing Paradigm
Case studies with mAbs have shown similar yield and purity compared with batch runs and could be associated with an increase in productivity, they note. Other advantages of continuous manufacturing in…
Article
USP Publishes Monoclonal Antibody Guidelines
This chapter includes purity assessments by chromatographic separation of size variants and capillary sodium dodecyl sulfate (CE–SDS) electrophoresis. In addition, it includes procedures for analysis …
Article
SEC in the Modern Downstream Purification Process
The objective of using SEC as a polishing step is to achieve acceptable ï¬nal product purity by separating out any remaining trace impurities. Separations using SEC require a rather long residence t…
Article
The Bullish Outlook for Biosimilars
Similar to other markets, head-to-head comparisons will focus on product safety, purity, and efficacy. Unique to the US, FDA will designate these follow-on biologics as either ‘biosimilar’ or ‘interch…
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The compound bDtBPP (98% purity, as determined by HPLC analysis) was provided by Amgen Corp., CA, US. In this study, the monoclonal antibody-expressing CHO DG44 cell line was used under license from C…
Article
Optimizing Resin Performance with Disposable Chromatography Solutions
The chromatography medium is the means by which protein purification is performed, and it must perform as expected, otherwise the purity of the drug can be impaired. Customers have expressed that they…
Article
DoE Provides Benefits, but Preparation Is Necessary
…sing size exclusion chromatography-high performance liquid chromatography (SEC-HPLC), or the percent purity. For spectral data from characterization assays, Janssen calculates the Center of Spectral …