Welcome to the Cardiogenics Holdings Discussion Forum

Paramagnetic Beads and QL Analyser are Proprietary Products

Free
Message: Re: Second Merck Agreement

Jul 29, 2010 12:40PM
1
Jul 29, 2010 01:18PM

Chilbear, the manufacturing experts with whom I spoke were not implying that the beads would not perform as CGNH and Merck have offered. They were acknowledging that to use the new Merck beads in the manufacturing processes currently approved by regulatory authorities each manufacturing company wanting to make such a change will have to conduct studies to demonstrate that the "amended" manufacturing process does not alter the product specifications of the approved product.

Overtime the new Merck beads could become recognized as the "preferred manufacturing standard" due to improved yields and lower costs. Time and development work will establish if this becomes reality.

Share
New Message
Please login to post a reply