Objective:

To highlight the advancements in biopharmaceutical manufacturing and drug discovery in 2025, focusing on in vivo CAR-T therapies and the industrialization of New Approach Methodologies (NAMs).

Key Findings:

• In vivo CAR-T therapies shift manufacturing inside the human body, improving scalability and access.
• The FDA Modernization Act 2.0 prompted a move away from unreliable animal models toward standardized NAMs.
• Standardization in organoid science is essential to overcome the reproducibility crisis.

Interpretation:

The biopharmaceutical industry is moving towards a future of standardized, reproducible engineering, enhancing both therapy accessibility and drug discovery predictability.

Limitations:

• The quality of starting materials and delivery mechanisms is critical for in vivo therapies.
• Standardization efforts in NAMs are still in progress and may face challenges.

Conclusion:

2025 marked a pivotal year in biopharmaceuticals, demonstrating that while biology is complex, it can be managed through engineering principles, leading to more effective therapies and drug discovery processes.