Analytical Methods

Sep 15, 2005
BioPharm International
By BioPharm International Editors
FDA and regulatory agencies worldwide have recently approved many advanced bioanalytical technologies. Receiving approval of advanced test methods for new biopharmaceutical products is relatively straightforward, provided clinical and process validation data are generated by the same (or at least similar) test method. However, regulatory approval becomes more difficult and time consuming when compendial test methods or test methods for already licensed biopharmaceuticals are changed.
Aug 01, 2005
BioPharm International
Misinterpreting the effluent profiles obtained during tracer measurements performed for determining packing quality can often lead to excessively large percolation velocities and exaggeration of packing problems. Highly useful and reliable information can be obtained through characterization of tracer effluent curves using the method of moments, information that could be critical for successful scale-up of chromatographic steps. This is the sixth in the "Elements of Biopharmaceutical Production" series.
Aug 01, 2005
BioPharm International
By BioPharm International Editors
The concentration range of proteins in human plasma spans approximately twelve orders of magnitude, with 85 to 90% of the protein mass distributed across as few as six proteins.
Jul 01, 2005
BioPharm International
The manufacturer should propose stability-indicating methodologies that provide assurance that changes in the identity, purity, and potency of the product will be detected.
Jul 01, 2005
BioPharm International
When data are not normal, a more efficient approach to monitor and control the performance of this assay requires transforming the data to a normal distribution. One of the most useful transformations was invented by Taguchi.
Jun 01, 2005
BioPharm International
By BioPharm International Editors
An anionic column with modified chitosan bead matrix performs well in purifying cell culture. A pair of cationic-exchange columns shows promise in purifying S25 antibody.
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.
native1_300x100
lorem ipsum