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Michiel E. Ultee, PhD, was Chief Scientific Officer at Laureate Pharma, Inc.
How to ensure smooth technology transfers.
The following is a transcript of a podcast interview recorded at the 2008 BIO International Convention held in San Diego.
BioPharm: What are the biggest challenges in a technology transfer process? Are the challenges different at different stages of tech transfer?
Ultee: I think they are and they fall under a couple of categories. The first is the technical area. The processes that come to us arrive at different levels of development. If a process is already well developed, then it is essentially a pure technology transfer. But if it's only partially developed, or not developed at all, then there is a lot more process development on our side. Some challenges arise when a process is very limited in development and then it takes some time to put in a new process. On the communication or people side, we have learned that it is important to set clear objectives and the scope, and for our project managers to work closely with the project manager or project director at the client. And this has worked well for us.
BioPharm: What are the key areas a biopharmaceutical company should focus on while planning for tech transfer to a CMO?
Ultee: Well, I think the first step is to assess the state of your technical knowledge about the project in the form of a detailed technology transfer report that you would provide to a CMO. And out of that, you then produce a smaller subset of information that you need for a request for quotation. The request for quotation is what we begin with. Before we respond to it, we sign a confidential disclosure agreement with our customers so that they are free to talk about the technical aspects of their project and our scientists can talk to their scientists and assess how we could best do the work.
BioPharm: How important is communication and documentation? Which routes of communication would you suggest to a biopharmaceutical involved in tech transfer?
Ultee: I think any CMO would say it's all important, and it has to be done the right way. For example, a lot of people prefer e-mail as the communication vehicle, and e-mail has its strengths in terms of speed and details, and in terms of transfer to other people, but it can also make it difficult when you are trying to have a discussion. We also shy away from e-meetings or e-discussions because there we want to have either a face-to-face meeting or a telephone conversation.
And communication has to be frequent, too. For most of our projects, we have a weekly project team meeting with key members of each company's team. This is typically a teleconference, although it could be face-to-face, depending on the location of our customer. That is followed up by more frequent communication between our project manager and the respective key contact at the customer. If there is something important, we don't wait for the regular weekly meeting; the project manager will do that right away.
BioPharm: In a recent webcast with BioPharm International, you talked about the use of pilot plants in tech transfer. Does using a pilot plant change the process significantly?
Ultee: Yes it does, and it has a couple of benefits that aren't immediately apparent if you don't have this kind of facility that is dedicated to producing engineering runs. By putting that in place, we created a nice spot where we could transfer the technology in a hands-on fashion between the development and the manufacturing staff at Laureate Pharma. And we can also have the client present, as we have always encouraged them to be. When we designed the plant, we put in large viewing windows so that the client could be on the outside, without having to gown up, and still be able see the process and check on it periodically. This way, the person in the plant can interact more easily with us.
BioPharm: How can a biopharmaceutical company efficiently handle the scale-up aspect of tech transfer?
Ultee: Again, having that pilot plant or engineering-run facility is really important for scale-up because it allows people in the key development and manufacturing groups to work together on their documentation as well as the process. What we have learned is that the process development people can sort of teach the process to manufacturing and the manufacturing people can also teach the process development people aspects of the large-scale equipment.
BioPharm: What is the role of the analytics group? How can methods transfer from analytical development to quality control be enhanced?
Ultee: The analytics staff are really the eyes and ears of the development and manufacturing groups because what they provide is the key information that you need, like titers in a bioreactors, how much did the cells make, and product quality, in terms of how much contaminant is removed in each step of the purification process, or was the protein inadvertently damaged or aggregated by a particular process step. Without the analytics group, you can't really know that. Without good analytics, you are flying blind. So analytics are part of every good process development strategy.
BioPharm: With biopharmaceutical production being increasingly outsourced across the country and even across the ocean, how can a biopharmaceutical company handle the "distance" challenge?
Ultee: There are a couple of routes to it. We do have some distant customers from Europe and Asia. Sometimes they will bundle their travel with some other needs they have on the East Coast of the US where we are located. At other times, we use a lot of teleconferences, and we sometimes do that very early in the morning or late at night to accommodate the time-zone differences. And as one of our Australian customers said, "We are far away from almost everyone, so we understand we have to go a long way to work with you from a time zone and meetings aspect."
This conversation has been edited for length and clarity.
Mike Ultee, is senior director of biopharmaceutical development and operations at Laureate Pharma, Inc., Princeton, NJ, 609.919.3390, firstname.lastname@example.org