Analytical Methods

Jun 01, 2005
BioPharm International
In a mere 30 years of development, a total of 23 MAbs and MAb-related proteins have been approved for medical treatments.
Apr 01, 2005
BioPharm International
Creation and qualification of scale-down models is essential for performing several critical activities that support process validation and commercial manufacturing. This combined article is the fifth in the "Elements of Biopharmaceutical Production" series. Part 1 (March 2005) covered fermentation. In this segment, we present some guidelines and examples for scale-down of common downstream unit operations used in biotech processes — chromatography and filtration.
Apr 01, 2005
BioPharm International
Contract manufacturers must plan for increased analytical resources in development and quality control.
Jan 01, 2005
BioPharm International
By BioPharm International Editors
Protein solutions used for research, vaccines, or therapeutics need to be free of contaminants. One of the chief concerns is the presence of endotoxins (lipopolysaccharides) because their removal from protein solutions is a challenge. Typically, removal techniques utilize adsorption onto surfaces of beads in batch reactions, onto beads packed in columns, or onto membrane surfaces.
Jul 01, 2004
BioPharm International
By BioPharm International Editors
Very significant progress has been made since the mid-1970s when dye ligands were first introduced.
Jun 01, 2004
BioPharm International
By BioPharm International Editors
Regression analysis determines the offsets between different methods and instruments that analyze cell media.
Oct 01, 2003
BioPharm International
By BioPharm International Editors
The biotechnology and pharmaceutical industries have some overriding concerns, namely regulatory and compliance issues, insufficient manufacturing capacity, and the economic challenges of producing niche drugs and therapies.
Oct 01, 2003
BioPharm International
By BioPharm International Editors
Helium Out-Detects Soap and Water
Jul 15, 2003
BioPharm International
By BioPharm International Editors
For maximum efficiency, high product yield, and purity, you must produce a homogeneous packed bed every time you perform a separation. Irregularities in packing cause uneven flow within the bed, resulting in band broadening, zone mixing, changes in flow rate, and subsequent loss of product yield and quality. Here we provide guidelines for reproducible column packing along with useful troubleshooting tips.
Jul 15, 2003
BioPharm International
By BioPharm International Editors
An overview of trends in process chromatography; how new innovations have improved production; and a guide to manufacturers involved in selecting chromatography equipment.
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