CryoPort Inc (CYRX)

[laser777]

I keep hearing about the personalization of medicine in the coming years. With the advance of immune therapies, it is estimated that half of the new treatments will need shipping at cryogenic temperatures. This is a portion of a post on another board about the manufacture, storing and shipping of a cancer vaccine. I thought it was interesting about the location of the plant, especially after watching the video. The whole post can be found here:

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=103663253


The regulatory requirements for living cell products are exceptionally difficult to meet in part because the products are often personalized. Cognate has an impressive regulatory track record. Over the last decade it has been responsible for manufacturing product for more than 20 INDs for living cells products and all of these INDs have been approved by the FDA. Impressively, no client of Cognate has been put on clinical hold due to manufacturing issues.

Northwest and Cognate Biosciences have spent over ten years pioneering a unique method of batch manufacturing for DCVax-L that is based on producing at least 3 years of treatments from one batch manufacturing cycle. They have developed special cryopreservation methods which enable a multi-year quantity of product to be frozen and kept frozen for years while maintaining its potency. This multi-year batch manufacturing and cryopreservation are essential elements that result in high costs only being incurred one time. Thereafter, the stored cryopreserved product is effectively an off the shelf product with little marginal cost. This should allow Northwest to price DCVax-L comparable to or below current biologics and small molecules used in cancer treatment and still achieve attractive profit margins.
Cognate’s facilities are located near the airport in Memphis, Tennessee to take advantage of worldwide air shipping hubs for both Federal Express and UPS. The logistics of personalized medicine requires that tumor samples and dendritic cell precursors gathered in blood drawn be flown in for processing and frozen finished product is then flown out. Cognate currently has capacity to service about 300 DCVax-L patients per year, which is sufficient for the phase III trial. However, Fraunhofer and King’s College London will add additional capacity. The current manufacturing facilities could be modularly scaled up over time to a capacity of 5000 patients per year; Dendreon launched Provenge with capacity of 2000 patients. This would support first year revenues from newly treated patients of $350 million. Also, it should be noted that the injections in years 2, 3 and beyond are manufactured with the injections for the first year and are available off the shelf.