mAb to commercial readiness in 24 months

When a potential monoclonal antibody COVID treatment needed to move from early development to commercial readiness under extreme time pressure, Verta was brought in to lead the entire CMC program.

The challenge

The program required rapid scale-up across multiple manufacturing operations simultaneously. Drug substance production, drug product fill/finish, and clinical packaging all needed to advance in parallel rather than sequentially - a level of coordination that demands deep operational expertise and real-time oversight.

Verta's approach

Verta rapidly scaled up and managed 7 CDMOs across drug substance, drug product fill/finish, and clinical packaging - simultaneously. Our team provided end-to-end CMC leadership, ensuring that each workstream progressed on schedule while maintaining the quality and regulatory standards required for a commercial-ready product.

Managing seven CDMOs in parallel is not simply a logistics exercise. It requires deep technical understanding, real-time risk management, and the ability to make decisions that keep every workstream moving forward together.

The outcome

The program achieved commercial readiness in just 24 months - a timeline that reflected both the urgency of the public health need and Verta's ability to execute complex, multi-site CMC programs at speed without compromising quality.

For help applying this expertise to your program, contact Verta.