Finding Biopharmaceutical PAT Success One Step at a Time

Talecris Biotherapeutics has a clear PAT mission and firm management support, but takes a measured, case-by-case approach to make PAT work where it will.

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By Paul Thomas, Managing Editor

While biopharmaceutical firms in particular have wrestled with FDA’s process analytical technology (PAT) initiative and how to meaningfully apply PAT to their complex processes, Talecris Biotherapeutics is moving forward, implementing an organization-wide PAT program at its state-of-the-art manufacturing facility in Clayton, N.C., and sharing its lessons learned and best practices with the industry. Talecris’ approach is based upon a clear PAT mission and upper-level support, but also upon small and affordable “quick wins.” Talecris has identified 22 PAT opportunities, and is currently working on seven of those, says Gerrit Vogel, the company’s PAT leader and manager of the process control systems (PCS) engineering group.

PAT is nothing new for Talecris, a maker of plasma-derived therapeutics that was spun off from Bayer Biological Products earlier this year. Many of its experts have worked on solutions for on-line monitoring and control as far back as the 1980s and 1990s. The key difference now is a more conducive regulatory environment since FDA released its PAT guidelines.

We spoke with four key members of Talecris’ PAT team to find out more about the company’s approach: Vogel, Senior Engineering Manager, Process Control Systems; Joydeep Ganguly, Principal Process Control Systems Engineer and PAT lead; Gerold Mohn, Bioanalytics Director; and Peter Vandeberg, Principal Research Scientist, Analytical Development.

Talecris will offer a more in-depth look at its PAT program and relevant case studies in the March 2006 issue of Pharmaceutical Manufacturing.

Pharmaceutical Manufacturing: What is Talecris’ general approach to PAT?

Joydeep Ganguly: A lot has been published about how difficult PAT is in the biologics industry. Our PAT approach, like many others in the industry, was to parse PAT efforts into smaller, more manageable tasks to begin with. We did not start by approaching PAT on a big-scale for entirely new processes; we tried to find small, quick wins. We also managed to identify and implement PAT in various areas — from packaging, to utilities, to production lines for yield improvements, to quality assurance. We used the early successes to build momentum for our bigger, more complex PAT efforts.

Gerrit Vogel: We are taking a comprehensive approach. Bayer has a long history of PAT, but focused on the process analyzers and analytical instruments. Talecris had quite a history to build on. About the middle of last year, we requested the position of a PAT engineer to support the multidisciplinary effort and to focus on the implementation of PAT projects. This is now Joydeep’s position, which was approved and shows the management’s commitment to this initiative.

P.M.: Where did you begin?

Gerrit Vogel: We decided to start very small. FDA’s PAT guideline was helpful in our planning and implementation. It was perfect timing for us, and we came up with a multidisciplinary approach, a master plan on how we wanted to structure PAT, a core team with members from all different disciplines that would also work with a steering committee.

When Talecris kicked off this initiative, we decided that we could not establish a huge PAT department and have a lot of projects that might bring a return on investment in a few years. We focused on things we either had already installed or were affordable to do in a reasonable time frame. We defined a quick win that was related to our water system, where we had already installed analyzers, and we have already tied them together. We implemented this in about two or three months.

We have a high-impact project of vacuum detection of our fill lines. We also have strategic projects that really go in the direction of the PAT guidelines, which takes an approach to look at the entire bioprocess in one of our new products. We tried to do several clear projects that show potential and success rather soon, but without forgetting the long-term strategy. It worked well for us.

Joydeep Ganguly: Gerrit and I have presented and wrote on the automation requirements of PAT. There’s a lot of interest in this from vendors and industry on issues such as data availability for PAT efforts. One of the first projects we looked into while implementing PAT was an IT concept that supported data transfer between different skids and analytical devices to allow for process understanding.

P.M.: But your PAT program really goes back much further than that.

Gerold Mohn: This whole thing started long before FDA’s guidelines and the PAT initiative. In R&D, we have always done a lot of things to characterize our processes, to make them more efficient and reliable. Our PAT initiative is actually a consequence of the groundwork that we laid out in the mid- to late 1990s.

Gerrit Vogel: We put together an analytical study for our site back in 1998. We looked at what the key quality attributes are that we need to focus on for on-line measurement, and did many other things as well. So it had some history.

Peter Vandeberg: In some ways, the biopharmaceutical industry is ahead of the chemical or small-molecule industry. For biological products, the process has always been important for defining your end product. So, it’s very common for biopharmaceuticals to be tested at multiple stages, for multiple intermediates. What we’re doing with PAT involved moving that testing from the lab to the production floor.

P.M.: Not everyone in the biotech industry has embraced PAT. In your opinion, does PAT lend itself well to biopharmaceuticals?

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