Advanced process monitoring: the ultimate alternative

Area of Science:

• Biotechnology
• Pharmaceutical Manufacturing
• Regulatory Science

Background:

• Animal testing for biological product quality is often unreliable for detecting batch-to-batch variations.
• Traditional final product testing may lack validity in ensuring consistent quality.
• There is a need for alternative methods to animal testing in pharmaceutical quality control.

Purpose of the Study:

• To evaluate parametric release as a viable alternative to animal testing for biological products.
• To demonstrate the effectiveness of in-process monitoring in ensuring product quality and consistency.
• To support regulatory approval of products released without final animal testing.

Main Methods:

• Implementing parametric release based on tightly controlled physical process parameters.
• Utilizing in-process monitoring techniques to ensure batch-to-batch consistency.
• Case study: Production of inactivated Bordetella pertussis cells to exemplify detailed process monitoring.

Main Results:

• Parametric release, supported by validated in-process controls, can replace final product testing.
• Detailed monitoring of the Bordetella pertussis production process confirms its predictability and consistency.
• On-line process parameter monitoring provides superior assurance of quality and consistency compared to traditional methods.

Conclusions:

• Parametric release is a scientifically sound alternative to animal testing for biological products.
• Validated in-process monitoring ensures product quality and consistency, facilitating regulatory acceptance.
• This approach enhances product safety and ethical considerations by reducing reliance on animal testing.