The updated FDA Guidance for Industry on Process Validation encourages an in-depth level of process understanding and ongoing life cycle continuous verification. The guidance explains that process validation consists of three stages: process design (process development studies), process qualification (evaluation of the process design) and continued process verification (life cycle monitoring, control and improvement of the post licensure product). Thus in a nutshell the regulators emphasise two central themes; process understanding and use of this understanding to develop systems to ensure that the process remains in a state of control throughout its lifecycle.

This regulatory emphasis on increasing levels of process understanding can sometimes cause confusion. This is mainly due to the fact that the developers and manufacturers of biopharmaceuticals are often unsure of what is required – what type of studies should be taken (one factor studies or multivariate experimental design approaches), how to qualify scale down models, how and when to perform risk assessment, how to utilise statistical techniques and learning from risk assessment, how to set acceptance validation criteria, etc. Thus the difficulty faced by the developers and manufacturers of biopharmaceuticals is how to answer these questions within limited resources and demonstrate to the regulators an increase level of process understanding to support their licensing application i.e. how to get the biggest bang for their buck?

As one of the world’s leading providers of contract process development and manufacturing services for the biopharmaceutical industry, Fujifilm Diosynth Biotechnologies have extensive experience in QbD approaches applied to both microbial and mammalian derived biologics. Our experience includes delivery of multiple process characterisation and process validation projects in addition to Continued Process Verification for our commercial products.

Fujifilm Diosynth has a variety of tools and approaches to facilitate the use of QbD principles, expertise in statistical analysis to support process understanding for effective delivery of robust manufacturing processes. In the upcoming webinar on 30th January, Process Development studies for Product Commercialisation, we will share our experience with some examples and tools we have developed to assist our customers in their journey. In this webinar we will answer some of the above questions raised, interactively take questions from the audience and allow the participants to gain an insight into how process development studies can be leveraged into a successful process validation.
Mahesh Shivhare & Graham McCreath