"Production specification (NOR) and Regulatory specifications (POR) are not always easy to define for biological products, especially without DoE, neither to implement in the regulatory package. How you overcome this ?
1) setting NOR/PAR without DoE, but via prior knowledge and data analyses
2) Implement QbD, and presenting 2 kind of specifications, in the package"
"Planification is or should always be possible even for biological products this means that planning for doing DoEs to define NOR and PAR is available whatever the product type. The difficulty in biologics is probably more the availability of the material (cost should not be an excuse and is certainly not a valid excuse for authorities to not doing the right experiments). It is where in addition to the methodology of DoEs, using prior information and adequate modelling such as Bayesian approach can be of great help to define those NOR and PAR even with reduced sample size and/or large variability. This implies a thorough development strategy definition ahead."
Learn more from Dr. Eric Rozet by viewing his presentation “Patient-Centric Commercial Specifications for Biotherapeutic Products, Strategies and Case studies” during the Expert Forum: Setting Biopharmaceutical Specifications: Navigating Regulatory Requirements in Accordance with ICH Q6B
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