As discussed a few days ago, antibody drug conjugates are seen as perhaps the next wave of advanced therapies for the treatment of many cancers - especially those resistant to current therapies. An ADC of course is an antibody linked to a cytotoxic small molecule. To deliver enough killing power to a cancer cell, this molecules have to be very toxic and are termed high-potent APIs (HPAPIs). Often cytotoxic or neurotoxic, HPAPIs need to be managed with the highest level of containment.
Recognizing that there was a market need for HPAPI manufacturing for ADCs and other applications, and that HPAPI manufacture fit with our history of chemistry capability, SAFC has added or is in process of adding a couple new facilities to serve this application, representing a total investment of more than $75M. This is in addition to our original standout facility in Madison, WI that has been SafeBridge Certified since 2003 - which was augmented with a cGMP kilo lab and pilot facility in 2008.
In September of 2008, we added a 600 ft2 suite in St. Louis and that was SafeBridge certified in June of last year, specifically to support ADC manufacturing.
The newest addition to the family is on its way. A new 45,000 sq. ft facility that meets Category IV standards is expected to come on line this year in Verona, WI close to the Madison facility. This facility includes development labs, a 150 liter mini-processing plant and two large scale cGMP manufacturing suites featuring reactors up to 4000 L. The facility has been built to support market demand for large scale HPAPI production capacity while meeting the highest quality standards. The demand in oncology is driving ADCs and this market is expected to grow at CAGR of 15 percent over next several years as compared with 4.5-5% for the rest of the pharma market.
Posted by Bruce Lehr March 4th 2010