Reinvention and knowledge transfer: Reviewing ISPE’s conference on Biotechnology
17 November 2016 • Author(s): Leif Poulsen, Global technology Partner, NNE Pharmaplan
First, I have to say that I think the attendees this year were extremely knowledgeable people compared to many other conferences, I have attended. This was evident from the critical and qualified questions that were raised during the Q&A sessions after each presentation, which really led to some interesting and insightful discussions. So, I left this year’s ISPE Conference on Biotechnology feeling very inspired.
Reinventing commercial biomanufacturing
The presentation which made the biggest impression on me, however, was given by Safaraz K. Niazi. Who talked about reinventing commercial biomanufacturing. Frustrated by the much too high prices of medicine today, he is completely rethinking the biotech process in an effort to bring down productions costs. Single-use, of course, is at the heart of the reinvention, but it goes well beyond that.
Safaraz K. Niazi, Founding Executive Chairman, Therapeutic Proteins International
Mr. Sarfaraz K. Niazi, Ph.D. serves as the Chairman and President of Therapeutic Proteins Inc. and also served as its Chief Scientific Officer. Mr. Niazi serves as Adjunct Professor at the faculty of University of Houston. He has served as Director of Technical Affairs at Abbott International where he held the Volwiler Fellowship. He has served as a professor of pharmaceutical sciences at the University of Illinois and The Aga Khan University.
Together with his team at Therapeutic Proteins International, he is scrutinising each step in the typical biomanufacturing process to see if it can be done differently. For instance, they have combined the processes of fermentation and recovery into one, reducing the number of tanks and eliminating centrifuges.
Likewise, they have brought down the need for pumps significantly by instead utilising something as simple (and cost-free) as gravity. By lifting and lowering single use bags to different levels, they can make the liquid substance run naturally through the process steps.
They have also taken a critical look at the bioreactor, in which large quantities of liquid, make it difficult to achieve a homogenous substance. They have solved this by placing the (medium-sized) single-use bags in a horizontal position. This leads to a lower fluid level, easing the process of homogenisation and making the stirrer obsolete.
HVAC systems is another area, where Therapeutic Proteins International has been able to reduce costs significantly. They have demonstrated that 80% of the HVAC is superfluous and have only one, where traditional biotech productions have four-five different systems.
I think everyone in the audience was thinking, ”that’s all very well, but can it be validated?”. But Mr. Niazi shot that doubt right down as he revealed that FDA has expressed clearly that validation shouldn’t be a problem. Interestingly, the start-up has been in close dialogue with FDA from the very beginning. So here, the HMRA inspector certainly has a great case to prove his point.
As an automation and IT professional myself, I also found the presentation from the two Boehringer Ingelheim executives on data science very interesting. Every biotech manufacturer knows the challenge of collecting sufficient data from small scale to correctly predict large scale.