Regulatory

Sep 01, 2006
BioPharm International
Good risk management tools dictate how much assay performance characteristics can deviate from ideal.
Sep 01, 2006
BioPharm International
Taking a purist stance is always tempting. It can, however, have unintended consequences.
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.
Aug 01, 2006
BioPharm International
Congress is not considering legislation that would expand FDA authority to regulate biologics.
Aug 01, 2006
BioPharm International
FDA did not gain any real teeth for regulating unsafe and ineffective products until a national health disaster in 1937 roused a public outcry.
Aug 01, 2006
BioPharm International
Is it possible to reconcile phage therapy, which is inherently variable, with requirements for tight product characterization and control?
Jul 01, 2006
BioPharm International
Food and Drug Administration is encouraging public–private collaborations to more fully explore the physical and chemical characteristics of nanoparticles.
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.
Jul 01, 2006
BioPharm International
Federal regulations are broad and open to interpretation. Most have not caught up with advancements in technology.
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