At ECI's recent April 2010 Cell Culture Engineering Conference XII in Banf, Dr. Thomas Seewoester, Amgen presented a talk on the history (progress) of cell engineering in the biopharm industry. He noted that the indsutry had come from talking about - how can we successfully produce a mAB to a position where overproduction (> 10 g/L) of a mAb is conceded to result in poor product quality. He presented the following time line and major conference themes from 1998 to 2010.
Dr. Seewoester indicated the industry has turned its head to some other issues besides increasing titer. Keys for success include more focus on time to clinic, providing operational flexibility, and creating process freedom to aid manufacturing. Product quality assessment is now more of a focal point than pure productivity in g/L.
Other speakers, like Dr. Brian Kelly, Genentech, agree that when titer reaches > 10 g/L other issues such as downstream purification effiency become more important. Downstream processing is an area that needs to improve - addressing issues like reduction of yield at harvest, deamidation, aggregation, and novel equipment needs.
Cost of Goods is in pretty good shape at < $100/g for many products. There is an opportunity now to pursue smaller markets, biosimilars and personalized medicine.
As the industry becomes more mature, there is a greater financial discipline that is required. Asset utilization becomes very important. Creating flexible processes that will accomodate product innovation is also key - "don't lock manifacturing in box."
As Dr. Seewoester concluded, "A culture of innovation is hard to build and easy to lose."
"Don't judge each day by the harvest you reap, but by the seeds that you plant." -- R.L. Stevenson
Posted by Bruce Lehr May 15th 2010.