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Accelerating ADC Process Development
The rapid advancement of ADCs put the fine balance between speed to IND and robust process development to the test, especially when scaling up and transferring production.
Bioprocess Intensification In The Real World
The biopharma “literature” is chock-full of big process intensification promises, but what is really achievable?
IND Success: Navigate Through The Regulatory Gray
Umoja Biopharma VP, Regulatory Affairs Helen Kim and NDA Partners' Expert Consultant Daniela Drago dig into the most common reasons for clinical holds, offer tips for avoiding and addressing them, and share best practices and resources for IND preparation in...
Early Process Considerations For Novel Protein Therapeutics
Complex protein-based therapies require developers to see the unforeseen and embrace new roles and responsibilities in sourcing both raw materials and outsourced expertise.