Preclinical & Translational Research

In a landmark shift that blends scientific progress with environmental responsibility, the United States Pharmacopeia (USP) has endorsed the use of non-animal-derived reagents for endotoxin testing. This decision marks a pivotal advancement in pharmaceutical safety testing while paving the way for a more ethical and sustainable industry standard. For decades, the pharmaceutical and medical device sectors have relied on…

Monoclonal antibody (mAb) drug development is rapidly evolving, driven by growing demand for precision therapies and a regulatory push toward non-animal testing methods. In this dynamic environment, Human Skin Equivalent (HSE) models are emerging as a powerful preclinical tool, especially for mAbs targeting dermatologic conditions or systemic diseases with skin involvement. As the FDA moves to phase out…

Viral clearance testing is a complex process that is crucial for ensuring the safety and efficacy of biotherapeutic products via demonstrating effective inactivation or removal of viruses during the manufacturing processing steps. Since each biotherapeutic product is unique in material, design, and processing, each viral clearance study is a custom design, but all have common…

Determining cytotoxicity is a critical step in assessing the biocompatibility of medical devices, biomaterials, and drug screening. There are a wide variety of methods available to researchers; however, too often cell-based assay results indicating poor cell health without greater context slow down or halt progress on the development of a medical device. Technology is constantly…

All medical device manufacturers strive to ensure devices and biomedical technologies are safe, efficacious, and fit for intended use. The biggest roadblock to accomplishing this is medical device testing to determine the most appropriate regimen for the device and its use. Although speed to market is key, a medical device CRO must devise and implement…

iFyber today released a whitepaper on an ex vivo model for mature biofilms. The model provides medical device and drug developers a new option to bridge the gap between traditional in vitro biofilm models and in vivo animal studies. Read more here.