Accelerating Process Development Through Digital Intelligence

Karna Shah
AbbVie 

This presentation explores how the Process Development team at AbbVie is transforming biologics process development by integrating digital intelligence and novel experimental approaches. Drawing on case studies from oncology and process characterization, it demonstrates how augmented intelligence and lab-in-the-loop concepts accelerate development timelines, enhance process robustness, and optimize resource utilization.

The talk highlights the evolution from traditional, iterative improvement to agile, platform-driven strategies—showing that speed and quality are no longer trade-offs. By pushing process boundaries and leveraging hybrid modeling, teams gain deeper insights and deliver high-value experiments that reveal true process failure limits. Ultimately, these innovations enable faster delivery of life-saving therapies to patients worldwide, underscoring the real-world impact of scientific progress.

Karna Shah

Karna Shah

Associate Director PDS&T  

Karna Shah is a group leader in Cell Culture Process Development at AbbVie, where Karna leads a team developing biologics processes across clinical, commercial, and contract manufacturing portfolios. Key focus areas include bioreactor engineering, process modeling, and process analytical technology (PAT).  

Over 12 years at AbbVie, Karna has held roles of increasing responsibility across MSAT, CMC Sciences, and Cell Culture Process Development. Notable contributions include leading cell culture development and commercial manufacturing support for three blockbuster assets, supporting seven validation campaigns, authoring process sections for two regulatory dossiers, and leading PAT deployment across AbbVie’s global biologics network.  

Karna is a subject matter expert in scale‑down model qualification, process characterization, control strategy development, and PAT. Karna is currently pursuing an industrial PhD at the University of Massachusetts Lowell and holds master’s and bachelor’s degrees in Biotechnology from Northwestern University and VIT University, India.      

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