Biopharmaceutical Analysis

Sep 01, 2006
BioPharm International
Good risk management tools dictate how much assay performance characteristics can deviate from ideal.
Aug 02, 2006
BioPharm International
By BioPharm International Editors
Nothing beats a good dictionary. It can clarify doubts, settle an argument, or prompt exploration into new areas of learning.
Aug 01, 2006
BioPharm International
Case studies were run to test Process Analytical Technology applications for protein refolding, diafiltration, and cation exchange chromatography. It is shown that it is feasible to design control schemes that rely on measurement of product quality attributes and thereby enable real-time decisions.
Jul 01, 2006
BioPharm International
For decades now, it has been said that "the process is the product" for biologics. Great care and consistency must be applied in their upstream manufacture—during fermentation, harvest, and early purification—to preserve their complex structure, which confers their activity and specificity. As the product moves to late-stage purification, however, the relative concentration of impurities and altered product forms is diminished. Also, the final dosage form of most large molecule biopharmaceuticals is the relatively simple liquid formulation of parenteral dosage form. In contrast, manufacturing the solid dosage forms common for small-molecule drugs involves more complex processes, such as mixing dry powders, granulation, manufacturing controlled-release matrices, and tableting.
Jul 01, 2006
BioPharm International
A novel calibration approach was developed that not only calibrates the X-axis, but also calibrates the peak shape.
Jun 02, 2006
BioPharm International
Using packed columns in process development activities limits the scope for appraising a large and diverse range of media.
Mar 01, 2006
BioPharm International
By BioPharm International Editors
Signal-to-noise ratios are useful in robust engineering to design products and processes that consistently deliver on target.
Feb 09, 2006
BioPharm International
Over the last three decades, numerous protein expression systems have been developed with various quality requirements on large and small scales. Huge steps have been made in large-scale protein production in mammalian systems while the small-scale mammalian systems are expensive and inflexible. Thus, small-scale production is done in simpler expression systems, sometimes sacrificing the quality of the proteins. However, relief is on the way.
Feb 01, 2006
BioPharm International
Lyophilized, or freeze-dried, materials are challenging samples for quality assurance and quality control (QA/QC) measurement because of the inability to open the container without corrupting the product. Near-infrared analysis presents itself as the QC method of choice for lyophilized materials due to its ability to penetrate glass or plastic containers to analyze the sample in a non-destructive manner. This study demonstrates the performance of a Fourier transform near-infrared (FT-NIR) spectrometer used in analyzing lyophilized samples of thrombin, a topical coagulant commonly used in the medical and dental fields. Key stability parameters for lyophilized thrombin include moisture and potency, which can be predicted simultaneously from a single spectrum using multivariate analysis.
Oct 01, 2005
BioPharm International
Departure from dilutional similarity can be interpreted as evidence that the groups of organisms are not comparable or the preparations do not contain the same active compounds.
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