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To: Madharry who wrote (35934)	11/13/2009 6:18:38 PM
From: Spekulatius	Read Replies (1) of 78669

re GENZ. The product affected are probably about 80%+ of GENZ revenues. Infact it seems that all of GENZ products have the problem. now it seems to affect only 1% of the vials produced but unless you know exactly which ones (batches). A 1% failure rate of this ugly nature is very high for a product like this. The drugs affected by the latest announcement include: Cerezyme, Fabrazyme, Myozyme, Aldurazyme and Thyrogen. Since those products use very different manufacturing processes it seems that the problem must be with the liquid handling into the vials /the vials itself or their cleaning, If indeed those steps are shared in between different products. At least that is my take as a process engineer <g>. It's going to be a while until they get the FDA from their back, in particular since this is the second gross failure (1st one being virus contamination).

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