Project category: Drug substance

Rapid Adventitious Agent Testing for Fail-Fast Process Decision-Making

Identification, Characterization and Removal of Host-Cell Proteins (HCP) in Chinese Hamster Ovary (CHO) Monoclonal Antibody Biomanufacturing Processes

Next Generation Sequencing (NGS) Internal Controls for Adventitious Agent Testing to Ensure Sensitivity for All Targets in Every Sample

At-Bioreactor Trace Metal Quantification and Statistical Process Control in CHO Cell-culture Production

Improved Lentiviral Vector Biomanufacturing for Cell and Gene Therapy Applications

Adaptive Process Control and Advanced Sensing for Robust mAb Glycan Quality

Scale-up Studies on Single Use Settlers for Clarifying Cell Culture Broth

NIIMBL Big Data Program Biopharmaceutical Manufacturing Ontology

Open-sourced Biopharmaceutical Manufacturing Ontology

Developing Directive Documents for Adoption of the NISTCHO Cell Line for Biomanufacturing Workforce Training

Enhancement of the End-to-End Manufacturing Testbed for Fast, Flexible Drug Substance Manufacturing

Protein A Chromatography Multi-scale Data Driven/Mechanistic Modeling (Phase 2)