Since its formalisation in the 1990s, VC has evolved into a highly specialised discipline that balances scientific rigour with regulatory compliance.1–3
In 2025, driven by the emergence of complex advanced therapies, the adoption of continuous manufacturing and the implementation of revised global guidelines, the field is transforming.4–7
The recent revision of ICH Q5A (R2), released in November 2023, has led to a shift in how manufacturers approach VC.
Despite this regulatory evolution, however, the field remains conservative, largely because of the global nature of biopharmaceutical markets and the uneven or delayed adoption of new guidelines across jurisdictions.
As a result, manufacturers must balance innovation with regulatory caution and tailor VC strategies to meet both scientific and compliance demands.
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