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Successful process characterization in biotech: A how-to-guide in 7 steps

Process validation (PV) aims at reassuring a manufacturer of constant product quality. It is also a regulatory requirement to achieve licensure of a pharmaceutical product. Failing to efficiently plan and execute activities on that stage leads to increased time-to-market. 

The fact that in the 22 pages of the latest FDA guidance document on process validation, statistical approaches and the need of statisticians in a multi-disciplinary team is mentioned no less but 15 times underscores the importance of showing statistical confidence about the chosen control strategy for critical process parameters (CPPs), input material and measured critical quality attributes (CQAs) during the manufacturing process (ICH Q8 (R2) 2009, 8). 

Figure 1: The aim of process validation is to identify the impact of process parameters of individual unit operations on the final drug substance product quality.

Every process characterization (PC) strategy aims to identify process parameters that impact product quality and yield:

  • Identify interactions between process parameters and critical quality attributes
  • Justify and if necessary adjust manufacturing operating ranges and acceptance criteria
  • Ensure that the process delivers a product with reproducible yields and purity

Successful PC is achieved when:

  • Scope, deliverables and timelines are well aligned between all stakeholders
  • Evidence-based decision making is increased and influence of the loudest voice during risk assessments is reduced
  • Equivalence testing is employed to identify potential offsets between scales
  • Impact of PPs onto CQAs is identified at minimal experimental effort
  • A model-based control strategy (e.g. PAR) is established for each unit operation
  • A holistic control strategy, taking the mutual interplay of all unit operations into account, is achieved using integrated process modelling. This shows that the manufacturing process is well understood and consistently delivers highest product quality in drug substance (DS) in the future.

In the following we show you how to successfully conduct a process characterization study (PCS) in 7 steps:

Figure 2: Tasks and typical timeline of a process characterization study


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