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Latest From Bowman Cox
US FDA inspection offers hints that Zhejiang Huahai’s genotoxic valsartan impurity could have been caught earlier, while EMA expands its quality review to other sartans that contain the same trouble-prone tetrazole ring. A micro lab will have to jettison its microbrewery, and compounding supplier Fagron must ID its API sources.
As agency offers further guidance on how and when to begin complying with Drug Supply Chain Security Act requirements, one twist is that some packages will need two barcodes, depending on the circumstances.
Contract development and manufacturing organizations are fielding requests from sponsors to ramp up for emerging novel treatment modalities like CAR-T cells and gene therapies but shouldn't "over-invest," consultant advises. Meanwhile, MAb production capacity, already huge, is growing 50% over the next five years to meet surging demand.
The constant battle of assuring the sterility of purportedly sterile products is underscored by recent warning letters, consumer alerts and other notices from US FDA. It’s clear at least that some firms are serious about microbial contamination risks – others, not so much.
Zhejiang Huahai has detected a second probable carcinogen in valsartan API it manufactured. Meanwhile risk analysis suggests cancer risk from the first probable carcinogen is low, at least so far.
Recent developments confirm the laser focus of the US FDA and the pharmaceutical industry on managing quality risks such as potentially carcinogenic impurities, product mix-ups and microbial contamination. But they also underscored opportunities like global regulatory harmonization, assay development and responses to negative pre-approval inspections.