At Sannova, we understand that navigating the complexities of protein analysis and therapeutic development requires adaptability and innovation. Let us share a recent collaboration where a sponsor’s gene therapeutic induces the generation of a protein with close homology with an endogenous protein. Sponsor’s prior CRO used a bottom-up approach -a process which is digesting the […]

The sponsor, a pharmaceutical solutions provider, embarked on the introduction of a groundbreaking oral solution product comprising two crucial components. T he sponsor decided to conduct an extensive extractable and leachable study on the packaging components to get ahead of increasing scrutiny by the FDA on E&L testing. Therefore, this study included PET and bottles […]

Our client, a leading pharmaceutical company, sought a comprehensive assessment of the Extractables and Leachables (E&L) profile associated with their Fentanyl Transdermal System packaging. With a commitment to ensuring product safety and compliance, they aimed to understand the potential impact of packaging components on the drug product. Challenge: The Fentanyl Transdermal System comprises multiple packaging […]

A 2019 review article in the Journal of Pharmaceutical Analysis points out that protocols for peptide bioanalysis must not only be specific, multiplexing, and high-throughput, they must also minimize undesirable matrix interference effects (Pinho et al.).  In fact, the authors describe the process of developing and optimizing techniques that overcome matrix interference effects as “burdensome” […]

A recent study from Janssen (2019) tells us that bioanalysts are switching from triple quadrupole mass spectrometry (MS) to high-resolution mass spectrometry (HRMS). While the triple quad MS, prized for its extraordinary1 sensitivity, has long been the standard analytical instrument of the pharmaceutical industry (as noted in Vereyken, et al., 2019), modern HRMS tools are […]

To date, the Food and Drug Administration (FDA) has approved about twenty-nine biosimilars1, and the European Medicines Agency (EMA) has approved seventy-seven2 biosimilars3. Given the increased awareness and significance of biosimilars, the FDA is expected to vet and approve even more in coming years. In fact, the latest Executive Order on Promoting Competition in the […]

Regulatory agencies such as the Food and Drug Administration (FDA) and European Medicines Agency (EMA) are dedicated to ensuring the safety and efficacy of drug products delivered to patients. This has led to the development of regulatory guidelines for the use of container closure systems (CCS) for parenteral drug products[1]. Parenteral drug products are packaged […]

The objective of this paper is to provide an understanding of the current challenges in lipid analysis and how mass spec is rapidly evolving to address current shortcomings                         Objectives Understand lipids and their role as biomarkers Understand the importance of lipid analysis and […]