Formulation and Process Development Articles

Traditionally, the summer months tend to be quiet for the biotech sector. However, the general markets experienced three solid months of gains as investors started to believe that the worst of the economic woes were over.

A butterfly flapping its wings over Brazil can influence the direction and severity of a storm in New England. Called the "butterfly effect," mathematic models have shown that even very small changes in one area of a system can create large variations downstream.

The new leadership at the US Food and Drug Administration is wasting little time in taking steps to make the agency more efficient and effective. The FDA is announcing new rules and policies almost daily and strengthening enforcement of manufacturing and marketing requirements to show the industry it means business.

The LEAN manufacturing and management model, developed from the Toyota Production System (TPS), has triggered major transformations in various manufacturing industries. Implementation in the field of biopharmaceuticals, however, has been limited to date.

Automated in-line dilution is an increasingly popular technology in the biopharmaceutical industry. In-line dilution is a process that can help solve capacity, financial, and quality concerns that biopharmaceutical manufacturing plants may be facing regarding process solution preparation and delivery.

t has been said that time seems to move faster the older you get, and judging by how quickly we have reached the end of 2009, I would say this cliché is certainly valid.

Laser-induced breakdown spectroscopy (LIBS) analysis begins with a focused laser beam that ablates the specimen (sample), generating a small spark. The light, optical emission from the spark, which contains spectral information about the composition of the sample, is collected by an optical system. These spectral data are analyzed for chemical identification.

A particular area of biophysical research in which Raman spectroscopy has great potential is the study of lipid–protein interactions. It is becoming increasingly clear that lipids can modulate membrane-embedded protein function and vice versa. This modulation can take both specific and nonspecific forms, but the underlying framework is defined by the amphiphatic nature of lipids and proteins.

The 36th FACSS conference, sponsored by the Federation of Analytical Chemistry and Spectroscopy Societies, will be held October 18–22, 2009, at the Marriott Hotel in Louisville, Kentucky.

Plenary Sessions