This excerpt taken from the ISIS 10-Q filed May 12, 2008.
Non-COGS Manufacturing Expenses (Non-COGS Mfg)
Non-COGS manufacturing expenses include costs such as those for ongoing stability testing, drug substance and drug product registration stability testing, transfer of API and drug product release and in-process methods, validation of analytical methods, regulatory support and photostability testing. Additionally, this category includes costs incurred for NDA supporting studies such as pH rate profile, pH solubility profile, freeze and thaw stability, terminal sterilization and shipping studies. Non-COGS manufacturing expenses also include process justification work for API and DP to support regulatory filings, costs associated with writing development history documents, costs incurred to add additional supply chain vendors as demands increase and tech transfer for API and drug product to Genzyme. Non-COGS manufacturing costs also include any other costs necessary to produce and maintain a CMC document to support product manufacturing.