Biography

Venkata Mangalampalli is a staff scientist in the Therapeutic Development Branch within NCATS’ Division of Preclinical Innovation, where he leads the chemistry, manufacturing and controls activities for the Center’s biologics and gene therapy product pipeline.

Prior to joining NCATS in January 2021, he spent more than 20 years in academic and industry environments, where he gained experience in biologics and drug development, from expression vector design to investigational clinical products, aimed at proof-of-concept studies for oncology and infectious disease indications. He is a chemistry, manufacturing and controls process expert on biologics and gene therapy drug development. Mangalampalli has extensive hands-on and leadership experience in mammalian expression vector design, stable cell line development, cell culture process development, process scale-up, technology transfer, failure mode and effects analysis, process validation, and good manufacturing practices support for clinical material generation. He serves as a technical subject matter expert on government contracts management for NCATS’ outsourced drug development of Investigational New Drug (IND)–enabling studies. He has expertise in auditing, selecting and managing activities of contract manufacturing organizations for process and preclinical development projects. He is also an accomplished operational efficiency professional in process development, including application of the Lean Six Sigma Principles; he is a Certified Lean Six Sigma Green Belt through the NIH Office of Logistics and Acquisition Operations.

Research Topics

Mangalampalli’s research interests are focused on collaborating actively with the scientific community — internal and external to NIH — to catalyze innovations and develop new strategies in preclinical drug development to accelerate first-in-human proof-of-concept testing and new drug discovery, as well as development strategies and technologies that have transformative potential for translational sciences. His current focus is on developing an open-access gene therapy manufacturing process platform by standardizing the manufacturing protocols and analytical methods for drug substance and drug product release. Additionally, Mangalampalli seeks to define and identify critical quality attributes of drug substances and products.

Selected Publications

1. CHO-DHFR Cell Line Development Platform: Application of Clonepix and Automated Mini Bioreactor (AMBR) Technologies to Meet Accelerated Timelines
2. Increased Production of a Secreted Glycoprotein in Engineered CHO Cells Through Amplification of a Transcription Factor
3. Single Variable Domain Antibody as a Versatile Building Block for the Construction of IgG-Like Bispecific Antibodies
4. Therapeutic Implications of a Human Neutralizing Antibody to the Macrophage-Stimulating Protein Receptor Tyrosine Kinase (RON), a c-MET Family Member
5. A Fully Human Recombinant IgG-Like Bispecific Antibody to Both the Epidermal Growth Factor Receptor and the Insulin-Like Growth Factor Receptor for Enhanced Antitumor Activity