The Second International Conference devoted to High-throughput Process Development will take place next month in Avignon, France, from June 4th through 7th . Process Development Forum spoke with Philip Lester, Director of Purification Development at Genentech, who is on the organizing committee of the Second International HTPD Conference.
Process Development Forum: You were part of the Organizing Committee at the First International Conference on HTPD in Krakow, Poland. Can you talk to us about how some of the topics addressed in Krakow in 2010 have shaped the conversation for next month’s conference in Avignon?
Philip Lester: The first conference was really structured in assess where we were coming from. We knew HTPD had been used in the small molecule world for a long time and we were fortunate enough to bring in a real expert there from Roche, Christof Fattinger, to talk about his experiences in the small molecule world and the enormous strides they made in doing very high throughput, very fast process development in the small molecules.
That launched the Krakow conference into a really interesting dialogue about where they were in the small molecule world to where we were in the large molecule world. The conference started off with a couple of sessions on case studies that really showed the delegates that HTPD had been fairly widely adopted for process development in the large molecule world—yet there was still a lot of opportunity to be pursuing.
One of the main things we saw in that first conference was that the acquisition, storage, recall, and analysis of data was going to become a significant bottleneck and we needed to figure out how to manage that large bolus of information. We concluded that, in fact, in large part, that bottleneck had been removed by some of the folks in academia and in industry who had foreseen this challenge and had gotten ahead of it. So that was a learning experience for us at the conference—that there wasn’t really an analytical bottleneck. Another thing we discussed was what we saw as eliminating the analytical challenge, that is you would be generating thousands upon thousands of samples per week rather than hundreds and would the analytical method of throughput be adequate in its current state to support that?
Another key question that was asked at that conference in 2010 was, how valid were the very small scale studies performed on a robot to scale up to laboratory and then manufacturing scale? And we had some very interesting topics there. People in industry had been thinking about this a lot and had made significant strides in understanding where some challenges might lie and demonstrating the applicability of the small scale data to large scale applications.
And then we had a closing session on the future of high-throughput process development, including some key thought leaders from industry and academia who some felt there was a huge opportunity lying ahead of us to completely change the way we do our work and others thought perhaps there would be an evolution of the way we do things rather than a revolution.
So it was a very interesting conference and was some good learning and some surprises for all of us, and all the delegates at the conference knew that there would certainly be a sequel to the conference to follow up on some of the areas that we identified in 2010.
Process Development Forum: So how does next month’s conference build on these areas?
Phil Lester: The Avignon conference is an evolution from the first conference. We sort of turned things around, starting with expanding the conference beyond what was largely focused on purification last time, with some formulation and quality by design topics, to really moving beyond purification to the upstream processing; looking at would be the cell culture fermentation, how was high-throughput process development used there with a direct link to downstream processing; and some things we’ve learned in the past and where we’re going now.
We also have an entire session on formulation. We see this as an evolving capability within industry and a lot of academic interest in protein stability in these different formulations. So we have an entire session on formulations.
And because data analysis was identified at the last conference as a key challenge, our plenary speaker will be talking about data analysis, some of the pitfalls and opportunities there; and we have an entire session now on managing large data sets.
A key aspect to this second conference is quality by design. We see that the health authorities really like the concept of quality by design. And we have clearly seen, from the last conference and since then, that the process knowledge that can be gained from using high-throughput process development can be leveraged to help us with our quality by design application to health authorities. We’ll also have some workshops and teaching sessions on how to use high-throughput process development in all the areas — upstream, downstream formulation, and potentially in quality by design.
The conference will with case studies of high-throughput process development in action, so what’s really happening right now and what are people benefiting from high-throughput process development.
Process Development: Since this conference is all about HTPD, can you quickly address how HTPD helps speed up the process and what are some its benefits?
Philip Lester: It’s been interesting to see how HTPD really has, in some ways, sped up the work but in some ways not really sped up the work. One person said at the last conference that what used to take weeks and weeks to generate data and then days to analyze the data, it’s now days to generate the data and weeks to analyze it. So it’s sort of reversed.
There is time savings we see in that we’re able to get a lot of information and make better decisions earlier on the directions to go in process development. So we don’t chase a bunch of dead ends. We basically avoid spending time on areas that aren’t really going to be promising. We also see that with very early look at new molecules entering the pipeline, we can predict whether or not they’re going to be challenging to present challenges for purification or formulation and that we can appropriately plan for those projects that might require more resources or those that require fewer resources.
So there is a speeding up of the process in process development but really what it does is help us with greater process knowledge and lets us go into process development better prepared. The greater process knowledge allows us to focus our work in the areas that need greater understanding and to focus less in the areas we already understand well.
In a word, HTPD is a better use of resources because it helps us avoid pursuing areas that are not going to be fruitful.