Tuesday, August 25, 2015

Bioprocess Characterization: An Interview with Graham McGreath, FUJIFILM Diosynth Biotechnologies

Dr Graham McCreath is Head of Process Design at FUJIFILM Diosynth Biotechnologies. In this post, Graham describes the company's approach to process characterization in advance of his presentation at BPI Boston in October 2015.

What is process characterization and how does it fit with the development and scale-up activities associated with new production processes? 

Process Characterization studies are a series of risk assessments and experiments undertaken as part of process validation and are carried out during late stage process development. These studies generate process knowledge and understanding and are used to develop robust control strategies for process qualification and commercial manufacture. The experiments are often carried out at laboratory-scale using qualified scale down models and statistical designs such as DoE. They are typically carried out once the final scale-up is complete when full scale data is useful in qualifying the required scale-down models.

What is special about the way FUJIFILM Diosynth Biotechnologies perform process characterization relative to other organizations? 

FUJIFILM Diosynth Biotechnologies have been carrying out process characterization for over 15 years and have completed more than 24 characterization projects. In that time we have built up considerable experience and expertise that benefits our clients with respect to how process information is generated, evaluated and how this is translated into a control strategy and registration package.  Our scientists and statisticians work collaboratively with clients to formulate and plan out the most appropriate robust approach for their needs balancing resources and timeline against residual risk. We have also developed some in-house QbD software packages as well to support modern process development; for example, our RAPTA (Risk Assessment Process Template Application) packages are FMEA based risk assessment tools that we use with clients as a predecessor to process characterization. The RAPTA tools enables us to identify, prioritize and document parameters that may be important in either a manufacturing process or an analytical method.

What skills or competencies should a manufacturer have in order to effectively characterize a process? 

Having an understanding of current regulatory expectations, engineering principles and how they apply to scale down, good documentation practices are all important competencies. It is also is very useful to have people in the organisation trained in experimental design. Modern DoE packages are becoming more user friendly but a good understanding of the pros and cons of design options and especially the interpretation of statistical data is very important.

As you developed your approach to process characterization were there any traps that engineers should avoid when developing their own approach? 

Generally, our advice would be to have a logical, well thought out plan, good documentation and rationales and not to overlook having a good scale-down model. The analytical methods to be used, where they are going to be applied and their development status should also be considered carefully. There is little point in executing a large experimental program if you don't have faith in your measurements.

Graham’s presentation is scheduled to take place on Thursday, October 29 at 2:30pm as part of the Cell Culture track.

Join me at #BPIconf
Contact me at nick.hutchinson@parker.com
Dr Nick Hutchinson has a Masters and Doctorate in Biochemical Engineering from University College London, UK where he focused on laboratory tools for rapid bioprocess development and characterization. He then worked at Lonza Biologics in an R&D function investigating novel methods for large-scale antibody purification before moving to an operational role scaling-up and transferring manufacturing processes between Lonza sites in the UK, Spain and USA. Nick now works in Market Development at Parker domnick hunter where his focus is in bringing Parker's strengths in Motion & Control to Bioprocessing. This will enable customers to improve the quality and deliverability of existing and future biopharmaceuticals.

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