Accurate protein expression quantification is critical to advance and accelerate gene therapy development. However, measuring protein expression reproducibly is a challenge for many traditional assays due to limitations in sensitivity and selectivity. For today’s gene therapy developer, Ion Mobility Spectrometry (IMS) delivers the sensitivity and selectivity needed to accurately identify and quantify protein products across […]

The pharmaceutical industry, especially emerging biopharma, is experiencing rapid and transformative growth. Over the past five years, the U.S. biotechnology industry has seen a compound annual growth rate (CAGR) of 7.2%, reaching $215.4 billion in revenue with an anticipated growth of 2.0% in 2024[1]. While COVID-19 drove significant investment in biotech, today’s expansion persists despite […]

Struggling with low abundance or isobaric species in complex samples? Discover how to overcome barriers in sensitivity and selectivity with our in-depth whitepaper on Addressing Challenges in Protein Quantitation with Ion Mobility Spectrometry (IMS)—a cutting-edge solution reshaping modern biopharmaceutical drug development. Learn how IMS can optimize your workflows by increasing confidence, streamlining processes, and reducing […]

In this AAPS eChalk Talk, our speakers will explore how Ion Mobility Spectrometry (IMS) is revolutionizing mass spectrometry by enhancing sensitivity and selectivity. They will discuss the advances in mass spectrometry and increase in throughput speed, specifically as it pertains to early-stage characterization in proteomics. Our experts will highlight how IMS introduces an additional dimension […]

This whitepaper offers a critical roadmap for navigating the complexities of regulatory compliance in biologic therapy development. Highlighting innovative strategies for chemical manufacturing and controls (CMC), this guide emphasizes laboratory practices and analytical methods to mitigate impurities, contamination, and toxicity, whilst ensuring strict adherence to ICH and FDA standards. Aimed at drug development teams, this […]

Oligonucleotide therapies, including small interfering RNA (siRNA), microRNA (miRNA), and inhibitory antisense oligonucleotides (ASOs), have emerged as a promising group of molecules for gene inhibition (Hu et al., 2020). These therapies hold particular potential in addressing rare diseases that lack cost-effective conventional treatments. Oligonucleotides, also known as RNA interference (RNAi) therapies, are also actively being […]

Unlock the highest level of confidence in your preclinical toxicology studies by harnessing the capabilities of High-Resolution Mass Spectrometry (HRMS). While traditional methods lack the sensitivity needed to distinguish subtle differences in mass-to-charge ratios (m/z) between ions, particularly on low-resolution instruments, HRMS provides a substantial advantage, resulting in robust results that surpass conventional methods. Predict […]

In the ever-evolving landscape of pharmaceuticals, the scrutiny surrounding extractables and leachables has become increasingly pivotal. As regulatory frameworks continually adapt to advancements in technology and scientific understanding, professionals in the pharmaceutical industry find themselves at the intersection of innovation and compliance. This eBook delves into the dynamic world of pharmaceutical extractables and leachables, shedding […]

Discover how high-resolution biomarker assays such as Meso Scale Discovery (MSD) and advanced Mass Spectrometry (MS) go beyond the limitations of traditional ELISA assays. Gain comparative insights into the superiority of high-resolution methods, and how they overcome central challenges in biomarker assessment and ligand binding assays (LBAs). Examine how regulatory authorities evaluate different techniques in […]

At Sannova, we recognize the intricate and often non-linear nature of R&D and drug development, standing ready to navigate the challenges alongside our clients. One such journey involved a client developing a nanoparticle-bound immunosuppressant. They started with a rat study and contracted a lab to analyze the pegylated protein in their formulation by ELISA. However, […]