Articles

1. Pfizer Issues A Challenge – Cook Pharmica Delivers 9/24/2014

   When Pfizer approached Cook Pharmica about producing a monoclonal antibody, Cook saw it as an opportunity to demonstrate its ability to deliver a product to the specifications the sponsor desired. Cook was fairly new at the time, and had been working with clients for just over four years. The company looked good on paper, and was one of a few facilities that could produce ingredients as well as final drug products in the same facility. Still, Cook executives knew they needed to prove they could measure up to the five driving principles (quality, cost, adaptability, timeliness, and risk) that were crucial to Pfizer.

2. Cell Banking And Storage 4/14/2014

   Regulatory-compliant cell bank production provides assurance that a uniform population of cells is preserved and that a sufficient supply of material is readily available for the life of the product.

3. Sun Pharma, Ranbaxy and the Deming Management Method 4/8/2014

   Where the Japanese have failed, the Indians will succeed? Sun Pharmaceutical Industries Ltd has not only agreed to step in and purchase Ranbaxy Laboratories Ltd, symbolically they have stepped up to the plate for the entire Indian manufacturing industry. It is in some regards an audacious move: The Japanese, known for high quality manufacturing standards, could not bring Ranbaxy through its challenges. It may not have been a strike out for Daiichi Sankyo, but they have taken a walk. Now an Indian manufacturer is in the batter’s box for team India.

   Sun Pharma is not downplaying the objective here. “ We are not looking at synergies of manufacturing; the focus is to achieve compliance" at Ranbaxy, said Dilip Shanghvi, managing director of Sun Pharma. Competitors or otherwise, shouldn’t all India wish them well? The rest of the world – and the FDA – is surely watching carefully.