Chitra Sethi

Vetter held a groundbreaking ceremony for its new facility in Ravensburg.

G. Steven Burrill released his 24th annual report on the state of the biotech industry at the BIO International Convention held in Chicago this month. Biotech 2010 -Life Sciences: Adapting for Success provides insight into biotech' s changing environment and how the industry will need to adapt to it.

The biopharmaceutical company Genzyme Corporation (Cambridge, MA), is expected to be fined $175 million by the US FDA as part of the agency?s enforcement action to ensure that products manufactured at Genzyme?s Allston, MA, plant are made in compliance with GMP regulations.

The biopharmaceutical company Genzyme Corporation (Cambridge, MA), which suffered from a series of manufacturing problems including viral contamination at its Allston Landing plant in June 2009, has announced that it will phase out its fill-finish operations from the plant gradually.

A critical GMP requirement for drug manufacturers is to validate analytical test methods to ensure that they are suitable for their intended uses. There are published guidelines available that the industry can follow for validation but there are none for qualification, which is a key step in the validation process.

AstraZeneca will cut 500 research and development positions at its US headquarters in Fairfax, DE.

German pharmaceutical and chemicals company Merck KGaA will buy US biotech equipment-maker Millipore for $7.2 billion.

Eli Lilly & Company received a warning letter from the US Food and Drug Administration, citing significant deviations from current good manufacturing practices (cGMP) in the manufacture of active pharmaceutical ingredients (APIs) at its facility in Carolina, Puerto Rico.

Merck & Co. (Whitehouse Station, NJ) has announced restructuring plans that include reducing its companywide workforce by 15% by the end of 2012.

Novavax will discontinue negotiations for the previously announced collaboration with Madrid-based ROVI Pharmaceuticals.