Analytical Methods

Oct 01, 2005
BioPharm International
Many industry professionals know that analytical testing for biopharmaceuticals for all raw materials, production in-process stages, and final containers must be validated, and they generally understand how this can be achieved. Many of us even understand the basic concepts of laboratory compliance and production process quality. However, how exactly are analytical test method performance and process robustness related and how do they depend on each other? Furthermore, how do we monitor and maintain the accuracy and reliability of analytical methods long after validation completion to ensure the suitability of these methods for measuring process quality?
Sep 15, 2005
BioPharm International
By BioPharm International Editors
Nearly every process conducted in a biotechnology company requires analytical methods to back it up. Since BioPharm's last guide published in December 2001,1 scientists have developed exciting, new tools for conducting research. Listed here is a sampling of new technological developments unveiled in 2005.
Sep 15, 2005
BioPharm International
By BioPharm International Editors
Factors such as quality, time to market, and regulatory changes are forcing an evolution to state-of-the-art analytical test methods.
Sep 15, 2005
BioPharm International
By BioPharm International Editors
"The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose" (International Conference on Harmonisation Guideline Q2A).1 "Methods validation is the process of demonstrating that analytical procedures are suitable for their intended use" (US Food and Drug Administration Draft Guidance for Industry, 2000 ).2
Sep 15, 2005
BioPharm International
By BioPharm International Editors
The methods used in most microbiological test laboratories originated in the laboratories of Koch, Lister, and Pasteur. While numerous changes have occurred in the chemistry laboratory, there have been limited improvements in methods used for microbiological testing.
Sep 15, 2005
BioPharm International
By BioPharm International Editors
Characterization of biopharmaceuticals (proteins) during early development is done for several reasons. The most important reason is the need to have supporting data that demonstrates the comparability of material used throughout development. This is particularly important as the production process is optimized and small changes in the process may affect the structure of the product. Demonstration of comparability of proteins produced throughout product development is more complicated, due to the inherently heterogeneous nature of many biologicals.
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.
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