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Holding Back

If not properly monitored, filters and plastic bags can keep back more than they should.

Merck Capital Ventures, a subsidiary of Merck & Co., has invested $1.5 million to expand its service laboratory. The transaction with NanoImaging Services will add high-resolution, three-dimensional transmission electron microscope (TEM) capability, which allows biopharmaceutical researchers to see complex macromolecular structures they create with resolution as high as one nanometer.

The US Food and Drug Administration issued a draft guidance for industry titled "Good Reprint Practices" regarding the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices.

Preparing sterile products requires manufacturers to control microbial quality. Sterility and endotoxin content are critical because failure to properly manage them can seriously harm, or even kill, patients.

Baxter Healthcare Corporation is providing an update to its January 2008 heparin sodium injection 1000 units/mL 10 and 30mL multi-dose vial voluntary recall of nine lots, which the company initiated as a precautionary measure due to an increase in reports of adverse reactions that may be associated with the drug.

A follow-on biologics approval pathway may be on the way. US Health and Human Services Secretary Mike Leavitt accepted Sen. Charles Schumer's (D-NY) suggestion that the Food and Drug Administration and Congress work together to formulate legislation for such a pathway.

Contract manufacturers of active pharmaceutical ingredients and intermediates unveil expansion plans and strategies at this year's Informex.