Delta PM Attends ISPE CEO Night!

“ISPE CEO night is always an event to look forward to each year.  I really enjoyed the primer on biotechnology's history that Bob Kiss, the VP of Sutro BioPharma, presented.  It spanned from the 1920's (insulin, blood clotting factors), 1970's (recombinant DNA), 1980's (eColi and CHO cell lines), 1990's (increasing yields), 2000's (cell free production) to 2010's (synthetic biology).  It's easy to forget how new this field really is.  I was looking back at my time at Bayer (2005-2007), where we were developing the Pilot Manufacturing Suite for a new protein-free Kogenate (Factor VIII blood clotting) that was using some of these groundbreaking cell-free production techniques.  Most folks outside of the industry have no idea how synthetic biology is going to change the industry in the next two decades.  Gilead, via its new acquisition CDL, is on the cutting edge in the Bay Area:

I also enjoyed hearing Kathy Yi, CFO for Sangamo Therapeutics, speak about their new project in Brisbane.  I was working at UltraGenyx during the beginning of this project and knew the PM from Dome Construction, who had just finished a project for us next door, so I had inside knowledge on the Sangamo project. 

Finally, Allison Moore, VP at Allogene Therapeutics, was describing the new techniques of scaling up production of CMC small/large-scale drugs.  The current method requires that the patient be healthy enough to generate the immune response required to harvest their own cells and purify them for reintroduction to the patient.  The new technique from her company is to de-couple the patient from the process by harvesting the immune response from healthy patients, stripping out the specific elements that will cause a foreign immune response from the sick patient, and then scaling it up using CMC so that multiple patients can receive the treatment.  This reduces costs tremendously and allows for the drugs to be available immediately, not weeks later as with the personal medicine techniques currently being used.”

— David O’Connell, Project Manager at Delta PM

“CEO Night is always a great event, and I enjoyed all three speakers at this year’s event.

Bob Kiss presented on Synthetic Biology, a process of extracting kinases from cells. This process is new to me, but companies like CDL and Sutro have been working on this technique for years.  CDL is actually one of my active clients, and I am currently expanding their BSL2 labs for this very purpose. This company is now expanding rapidly under the guidance of Kite Pharma and their mother company Gilead. 

Allison Moore, as David mentioned above, shared her insights on how to scale up manufacturing processes to accommodate growth for small-scale processing, a method using CMC.  She went on to talk about gene therapy and introduce us to a new method of processing T-cells.  This technique takes cells from healthy patients, engineers the cells, and makes them available to all patients in times of need.  This new process is much quicker than the traditional way of processing cells — resulting in potentially higher survival rates.

Kathy Yi from Sangamo spoke mainly about her recently completed project for her company in Brisbane. As a CFO of a small company of around 300 employees, she was challenged by budget constraints and had to wear multiple hats while running this project to completion. She was heavily involved in the construction process and also orchestrated all aspects of design and construction. She was able to complete a huge multifunctional facility in 13 months, for which construction started in December 2017 and was completed in January 2019.”

— Tuyen Nguyen, Director of Project Management at Delta PM

Many thanks to the ISPE San Francisco Bay Area Chapter, Robert Kiss, Alison Moore, Kathy Yi, and all our attendees for making this night such a great success. Looking forward to seeing you at future events!