How can our biologics drug development program reach from IND-to-BLA faster?

Designed to move medicine forward, our IND-to-BLA filing program provides the high-quality, late-phase development and manufacturing services for those companies looking to bring biologics and bioconjugates to the market.

Essential to this program are:

• Process Development
• Process Characterization
• PPQ
• Process Validation
• Process Control Strategy
• Analytical Development & Method Validation
• Extended Viral Clearance Modeling
• EPoC, HCP Characterization & Validation
• Late Phase Clinical Trial Material
• Commercial Batch Manufacture
• Regulatory Support
• Filing Gap Assessment

From antibody development to IND and through to BLA, Abzena are ideally positioned to partner with you to accelerate your drug approval process and reach a key milestone.

We are an end-to-end CDMO partner you can trust with over 20 years of complex biologics and bioconjugate experience.