BioPhorum approach to the registration of innovative raw materials using quality by design (QbD) principles

Through the experience of its members, BioPhorum has defined a best practice approach to the registration of innovative and complex raw materials with major benefits:

• Increased flexibility of supply through enhanced knowledge and understanding of products and processes, of those attributes that are critical to quality, thereby easing a sound comparability strategy
• Enhanced quality of regulatory submissions through the demonstration of product and process knowledge and understanding
• Potentially improved product and process robustness

The BioPhorum approach is based on quality by design (QbD) principles and consists of four steps:

1. Definition of the target material profile (TMP)
2. Description of the material attributes
3. Review of the product summary control strategy
4. Identification of the critical material attributes (CMAs) required to ensure product quality and safety

When the BioPhorum approach is registered in marketing applications, it allows for simplification of the regulatory lifecycle management of products, in line with ICH Q12. The BioPhorum approach is applicable to different families of non-compendial raw materials used in the manufacture of biologics, such as ancillary raw materials, cell and gene therapy (CGT) starting materials, excipients and adjuvants, good manufacturing practice (GMP) support materials, primary packaging components, process aids and single-use components, making it potentially very powerful for the industry. The approach has already been used by BioPhorum member organizations and accepted by national health authorities (NHAs). The approach is exemplified with the case of a virus retentive filter used for the manufacture of monoclonal antibodies.

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• Create Date 18th January 2022
• DOI https://doi.org/10.46220/2022REG001
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