In 2011, the United States and European regulators issued new process validation guidelines. The new guidelines now emphasize:

  1. The demonstration of process understanding (process characterization).
  2. Risk-based identification of critical process parameters.
  3. Implementation of well-validated control strategies.
  4. Quality by Design (QbD) for biologics development and manufacturing.

Process characterization is a critical element of regulatory guidance for biologics development. Process characterization is an experimental work plan in which operational parameters are purposely varied to determine their effect on product quality attributes and process performance. It establishes Critical Process Parameters (CPPs) and Proven Acceptable Ranges (PARs) by Design of Experiment (DoE) and statistical analysis.

The goals are to identify critical operating and performance parameters, define control limits for essential parameters of the process, demonstrate the commercial process’s robustness, and provide technical information about the process. It is valuable in maintaining smooth manufacturing operations and minimizing lost batches. It provides supporting information for lot release justification for atypical batches.

So, what makes process characterization important? Here are some of the reasons:

  1. FDA recommends process characterization
  2. Process characterization can shorten your project’s timeline and reduce the costs
  3. Process characterization follows quality-by-design (QbD) requirements and is the critical step in QbD
  4. Process characterization offers a deeper understanding of your processes and product
  5. Process characterization helps set up control strategies
  6. Process characterization can ensure higher product quality

So, when to perform process characterization? To meet regulatory requirements, process characterization studies need to be completed before process validation, and it is an essential step in the commercialization of a new biological drug. Usually, the process development cycle from preclinical to manufacturing could take around three years, a very long process. And clients typically require rapid advancement in the timeline to production for early clinical candidates. Process characterization can help them shorten the time frame and save more energy.

Traditionally, the characterization of biomanufacturing processes has been performed using a two-stage experimental strategy: screening design (CPP and KPP) and response surface design (PARs and NORs). An efficient DoE methodology that combines screening & response surface design can save time and reduce cost by 25%-50% without compromising product quality.

Boston Institute of Biotechnology is very experienced in process characterization. We deliver efficient process characterization programs to support both product registration and commercialization. If you already have a process in phase 2, you should consider the process characterization study and contact us.

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Yu Xu

Author Yu Xu

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