Fortrea Partners with Emery Pharma to Support FDA-Regulated Drug-Drug Interaction Studies Involving Rifampin
Wednesday, June 25, 2025
Fortrea a leading global contract research organisation (CRO), has entered into a strategic partnership with Emery Pharma, a specialist CRO offering analytical and bioanalytical testing under current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP). The collaboration aims to support drug-drug interaction (DDI) studies by enabling testing of rifampin batches for 1-methyl-4-nitrosopiperazine (MNP), a known impurity.
Under this agreement, Fortrea will work with Emery Pharma to provide a rapid, batch-by-batch assay that ensures MNP levels in rifampin remain below the Acceptable Intake (AI) limits set by the U.S. Food and Drug Administration (FDA). Rifampin is commonly used in DDI studies for its ability to induce the CYP3A4 enzyme, which plays a critical role in drug metabolism.
The decision to collaborate was based on Emery Pharma’s recognised strengths in high-quality analytical and bioanalytical testing. This partnership enhances Fortrea’s ability to include rifampin in its early-phase clinical pharmacology trials, while ensuring regulatory compliance and patient safety.
The presence of nitrosamine impurities like MNP in rifampin has drawn attention in recent years. In 2021, FDA testing revealed that MNP levels in all rifampin batches exceeded the then-established safety threshold, leading to increased caution around its use. Although alternative compounds were considered, they often posed challenges related to safety or delayed onset of action. In response, the FDA updated its guidance in 2023, setting new acceptable intake levels for MNP in rifampin.
Through this partnership, Fortrea now offers clients a flexible, compliant approach to using rifampin in DDI studies. This capability supports quicker timelines, improved data quality, and reduced risk in early-stage drug development.
The collaboration combines Fortrea’s expertise in clinical trial execution with Emery Pharma’s proficiency in analytical sciences, supporting the delivery of high-standard, regulatory-ready data for global drug development programmes.
Source: globenewswire.com
