NIH-funded research U01 cooperative agreement

Advancing continuous manufacturing of monoclonal antibodies with a validated modeling platform

Official title: Advancing continuous biomanufacturing of monoclonal antibodies using an experimentally validated modeling platform

Funded at University of Delaware · NIH-11420164 · Data updated 2026-11-12

A research team at the University of Delaware will develop and test a combined experimental and computer model approach to improve how monoclonal antibodies are produced continuously.

Quick facts

Grant typeU01 cooperative agreement
Study typeNIH-funded research
Funding institutionUniversity of Delaware
NIH-funded
Lab location1 site (Newark, UNITED STATES)
Project startSeptember 1, 2022
Project endAugust 31, 2027
Funding year2026
Award (this year)$884,858
NIH project number5U01FD007695-05
Project IDNIH-11420164 on NIH RePORTER

Who could benefit from this research

Could help

This grant does not recruit patients; it focuses on manufacturing technologies and modeling.

Less likely to help

Patients are not directly enrolled; the research center on processes rather than clinical care.

What this research studies

This project creates an experimental setup alongside a computational framework to study continuous manufacturing of monoclonal antibodies. It aims to build a multiscale model that links cell culture conditions with downstream purification to predict product quality and process performance. The work will validate the model with real experimental data, then use it to optimize operating conditions and enable better process control. The ultimate goal is to shorten development times and improve consistency in biologics manufacturing with fewer impurities.

Why it matters

Potential benefit: If successful, the approach could lead to more efficient, reliable, and scalable production of monoclonal antibodies for patients.

How similar studies have gone: Previous work in biomanufacturing modeling shows promise in linking process parameters to product quality, supporting this direction as plausible and potentially impactful.

Where this research is happening

  • University of Delaware
    Newark, United States
    Active

Researchers

  • Principal investigator: Ierapetritou, Marianthi — University of Delaware
  • Study coordinator: Ierapetritou, Marianthi

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.