Last Thursday, May 6th, I attended the ISPE (International Society for Pharmaceutical Engineering) New England Chapter Biopharma 2010 Conference held in Warwick, Rhode Island. A presentation was given by Geraldine Taber, Pfizer’s Global Technology Group Leader titled “Demise of the Round-Bottomed Flask – How new Battle Tools in the Lab of the Future are delivering value for R&D”.
Dr. Taber makes a compelling case for the use of modern process development tools based on the Return on Investment (ROI) of lowering the Cost of Goods (COG’s) of Active Pharmaceutical Ingredients (API’s), and backed it up with a real-life example. She specifically mentioned the use of Automated Laboratory Reactors (ALRs) and real-time in situ reaction analysis. Dr. Taber said that there is a greater focus on COG’s than ever before at the time of launch of a product to market, and that the target is a 5X decrease over what has traditionally been acceptable. This was stated to be in the same realm of what manufacturers of generic pharmaceuticals target for the Cost of Goods.
Dr. Taber went on to say that the time has come to move on from 50 – 100 year old technology and gave 5 distinct shortcomings of the round bottom flask:
- There is no data acquisition about what happened during the reaction
- The round bottom flask doesn’t look like a plant
- It only carries out one reaction at a time
- The round bottom flask doesn’t predict behavior at scale
- There is only limited control of the reaction
Dr. Taber also stressed that there really needs to be a culture change and that one of Pfizer’s secret weapons was multi-disciplinary co-located teams – changing the way that team members interact as all of the team members are physically together.
The ROI example was that of an API where 25kg was required for clinical trials. They were able to reduce COG’s by 76% going from $87,000/kg to $20,000/kg which resulted in more than $1.6 million in savings – and she stressed that this was just the savings in the COG’s for the API for the clinical trials. I can only imagine what kind of savings that would translate to over the lifetime of even a relatively successful pharmaceutical compound that makes its way to market. This is the first time that I have seen the ROI of COG’s for product at time of launch used to justify the investment in modern process development tools.