Publications by authors named "Jill Coghlan"
Post translational modifications (PTMs) have been shown to negatively impact protein efficacy and safety by altering its native conformation, stability, target binding and/or pharmacokinetics. One PTM in particular, shuffled disulfide bonds, has been linked to decreased potency and increased immunogenicity of protein therapeutics. In an effort to gain more insights into the effects of shuffled disulfide bonds on protein therapeutics' safety and efficacy, we designed and further optimized a semi-automated LC-MS/MS method for disulfide bond characterization on two IgG1 protein therapeutics-rituximab and bevacizumab.
View Article and Find Full Text PDFComplex generics are generic versions of drug products that generally have complex active ingredients, complex formulations, complex routes of delivery, complex dosage forms, are complex drug-device combination products, or have other characteristics that can make it complex to demonstrate bioequivalence or to develop as generics. These complex products (i.e.
View Article and Find Full Text PDFIon mobility-mass spectrometry (IM-MS) and collision-induced unfolding (CIU) assays of monoclonal antibody (mAb)-based biotherapeutics have proven sensitive to disulfide bridge structures, glycosylation patterns, and small molecule conjugation levels. Despite promising prior reports detailing the capabilities of IM-MS and CIU to differentiate biosimilars, generic mAb therapeutics, there remain questions surrounding the sensitivity of CIU to mAb structure changes that occur upon stress, the reproducibility of such measurements across IM-MS platforms, and the correlation between CIU and differential scanning calorimetry (DSC) datasets. In this report, we describe a comprehensive IM-MS and CIU dataset acquired for three Infliximabs: Remicade, Inflectra, and Renflexis.
View Article and Find Full Text PDFArticle Synopsis
- Humira® (adalimumab) has been a leading biologic drug with nearly $20 billion in sales in 2018, but faced a decline in 2019 after biosimilars entered the European market.
- By late 2019, about 35% of European patients had switched to these biosimilars, contributing to a decrease in Humira®'s annual sales to around $19 billion.
- The review discusses the impact of biosimilars on the adalimumab market, comparing their formulations, delivery, activity, and properties, while preparing the public for similar changes as these biosimilars are expected to enter the U.S. market in 2023.
Article Synopsis
- Biosimilars like Acellbia® are expected to lower prices and improve access to effective biologic therapies, but there are still concerns about their similarity to original products and the availability of comparative data.
- A study was conducted comparing the innovator drug Rituxan® with the Russian biosimilar Acellbia® using advanced mass spectrometry techniques.
- The findings revealed that while the two products were generally similar, Acellbia® showed differences in glycosylation patterns that enhanced its biological activity, indicating potential advantages over Rituxan®.