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, […]

Jason Apter discusses the role CROs play in the drug development process, the role of AI, and strategies to accelerate drug development.

In the dynamic world of life sciences, mastering customer experience (CX) is paramount. Discover how one can tackle unique challenges and boost revenue through effective CX. Join us for this insightful conversation on leadership, innovation, and prioritizing CX.

The new Sannova: the big science, boutique CRO redefining the future of bioanalytical and analytical services. We embarked on a quest for excellence, committed to crafting an unrivaled customer experience hallmarked by quality, speed, and flexibility. The world of pharma & biotech is changing: the surge of biologics & novel modalities; the swift wave of […]

In the world of pharmaceutical clinical trials, success depends on many factors, but one stands out as a crucial cornerstone – robust data to meet regulatory guidelines. The Z-factor is a statistical measure used to evaluate the quality of an assay or screening method. Throughout the drug development process, scientists encounter an accumulation of variability […]