Search results for "analytics"
Article
Emerging Therapies Test Existing Bioanalytical Methods
Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex thera…
Article
Protein Analysis with Size Exclusion Chromatography
Size exclusion chromatography (SEC) is widely used in several different analytical applications from basic research to quality control of biotherapeutics. This white paper presents fundamentals abou…
Article
Scaling Up Novel Therapies
Analytics and control systems become critical to delivering reliable, accurate, and precise data for the duration of the entire batch, says Levison. “Not only strong process monitoring and control, bu…
Article
A Look into the Future of Biopharmaceutical Quality
A Look into the Future of Biopharmaceutical Quality
Quality experts share insights on what the future may hold regarding regulatory quality requirements for biopharmaceuticals.
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Article
The Challenge of Disruptive Technologies in Bioprocessing
The Challenge of Disruptive Technologies in BioprocessingIncreasing demand for biologics is driving the need for innovation in bioprocessing.
Jul 01, 2018
Increasing demand for biologics is drivin…
Article
Making the Move to Continuous Chromatography
Making the Move to Continuous Chromatography
Early adopters are benefiting from lower costs and increased productivity.
By Cynthia A. Challener
Tashatuvango/Shu…
Article
Analysis of Glycosylation in Biosimilars
A step-wise process is used to characterize glycans and understand the functioning of a molecule for biosimilar development.
The structures of protein drugs such as monoclonal antibodies are mad…
Article
Use of Multivariate Data Analysis in Bioprocessing
In a similar application, researchers have addressed the issue of late detection of irregularities in a chromatographic process (caused by offline analytics) by using a selective inline quantification…
Article
Ensuring the Quality of Biologicals
May 02, 2015
By Stephen Wicks, PhD
Pharmaceutical Technology
Volume 39, Issue 5
The European Pharmacopoeia (Ph. Eur.), which celebrated its 50th anniversary in 2014, provides common …
Article
Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 4
Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …