Bioanalysis Zone

Encoded protein detection is plagued with low and transient concentrations, endogenous protein interference, matrix-dependent recovery, proteolytic degradation and more.

So, what’s the solution? The QPS, LLC team says strategic use of LC–MS for peptide-level specificity and LBAs for sensitive quantification – often in combination.

Read more over on Bioanalysis Zone >>> https://hubs.ly/Q04wwslX0

Are you navigating the complexities of biomarker validation in neurodegenerative trials?

From assay sensitivity to regulatory expectations, biomarker testing comes with unique challenges. How are leading researchers overcoming them?

Join our upcoming webinar where experts in clinical drug development, biomarker science, and bioanalytical testing share strategies for advancing neurodegenerative drug development through integrated biomarker solutions.

Webinar: Advancing bioanalytical testing for neurodegenerative therapeutics
Date: Wednesday, September 30
Time: 09:00 PDT | 12:00 EDT | 17:00 BST

Register >>> https://hubs.ly/Q04wKqvj0

Metabolomics has long struggled with a fundamental challenge: confidently identifying the metabolites detected in biological samples. While the field established clear, evidence-based identification standards over a decade ago, including the widely adopted Metabolomics Standards Initiative (MSI) with its four-level confidence system, these guidelines are routinely ignored in published research. The result is a growing body of literature plagued by overconfident annotations, where tentative matches are presented as definitive identifications, and biologically implausible “biomarkers” go unchallenged.

In this interview, Ian Wilson, a visiting professor at Imperial College London and the University of Liverpool, discusses what’s driving this crisis of rigor in his recent Perspective article: pressure to publish, gaps in analytical training and insufficient understanding of biochemistry. Ian argues that while science is ultimately self-correcting, the cost of pursuing false leads—in time, resources and potentially clinical translation—is too high to accept.

Read the full interview here 👉 How Metabolomics Identification Has Lost Its Way - Bioanalysis Zone (https://hubs.ly/Q04x2JpJ0)

We're excited to see you in New Orleans ✈️

Bioanalysis Zone are proud to announce that we're official media partners for AAPS ! If you'd like to be involved in any of our content, or want to stop by to learn more about our offerings, we'll be at booth #829 (a few sweet treats may or may not be on offer...👀🍬)

If you haven't already registered, you can do so here >>> 2026 Registration Information - American Association of Pharmaceutical Scientists (https://hubs.ly/Q04wK5KZ0)

Bioanalysis is fundamental to drug discovery, providing the quantitative data needed to evaluate the safety, efficacy and pharmacokinetics of new therapeutics.

Read the Guide from Thermo Fisher Scientific to learn more about integrated workflows for small and large molecules >>> https://hubs.ly/Q04wzbQR0

How can you achieve more precise quantification in cell and gene therapy bioanalysis?

Join our webinar on 23 September to discover how droplet digital PCR delivers sensitive, accurate quantification without standard curves. In addition, the webinar will cover practical considerations for assay validation within an evolving regulatory landscape.

Title: Digital PCR in cell and gene therapy molecular bioanalysis: from application to validation
Date: Wednesday, September 23
Time: 7:00 PDT | 10:00 EDT | 15:00 BST

Registration now: https://hubs.ly/Q04wK6Wp0

Fortrea has agreed to acquire the Early Phase Services division of Worldwide Clinical Trials, bringing Worldwide’s clinical pharmacology unit and bioanalytical laboratory operations into Fortrea’s early clinical development platform, with the aim of creating a more integrated pathway from first-in-human studies to later-stage development.

Read more about the deal here: https://hubs.ly/Q04wRfxN0

Hematogenix’s proprietary next-generation flow cytometry assay measured the primary efficacy endpoint supporting the US FDA's accelerated approval of ZENBEXUSTM, the first CELMoD therapy approved by the FDA for multiple myeloma.

Full story here >>>

Hematogenix's flow cytometry assay named in ZENBEXUS approval Hematogenix's proprietary next-generation flow cytometry assay measured the primary efficacy endpoint supporting the US FDA's accelerated approval of ZENBEXUS.

Are serum protein measurements sufficient for LNP-mRNA therapeutics? Not quite. While circulating concentrations help evaluate systemic exposure, they don't reveal what's happening at the tissue level – especially for non-secreted or locally acting proteins.

In part three of our gene-based therapeutic delivery series, Aurora VanAuken, Zamas Lam and Xun Wang from QPS, LLC discuss why tissue-level expression assessment is critical for understanding organ-specific activity, potential toxicity and off-target translation risks.

Read here >>>

Integrating mRNA and protein expression data in LNP-mRNA biodistribution studies: bioanalytical strategies and regulatory considerations In this interview, the QPS team addresses critical bioanalytical strategies and regulatory considerations for LNP-mRNA therapeutics.

Have you downloaded our guidebook on ‘Quantifying oligonucleotides – extraction and separation'?

This guide highlights practical tools and considerations to help laboratories improve oligonucleotide extraction, recovery, chromatographic performance and workflow consistency.

Learn more >>> https://hubs.ly/Q04r6mV80