Articles

Nitrosamine contamination in pharmaceuticals has become a major regulatory concern due to their potent carcinogenicity, requiring ultra-trace-level detection to ensure patient safety. Advanced LC-MS/MS workflows provide the necessary sensitivity, selectivity, and robustness to accurately quantify nitrosamine drug substance-related impurities (NDSRIs), even within complex pharmaceutical matrices. Case studies with betahistine, orphenadrine, and chloropyramine demonstrate how streamlined LC-MS/MS strategies can reliably detect and confirm nitrosamine impurities well below regulatory thresholds.

Executive Summary: Mastering Nitrosamines Analysis With Streamlined LC-MS/MS Solutions

This piece of content details how LabVantage Pharma LIMS serves pharmaceutical manufacturers with built-in compliance, speed, and quality assurance. It describes a pre-validated, purpose-built platform that supports FDA 21 CFR Part 11, EudraLex Annex 11, and GxP standards. The system enables rapid deployment (go-live in ~90 days), automated workflows, instant Certificates of Analysis, and robust security. Labs can simplify operations, strengthen compliance, and accelerate batch release while safeguarding product quality.

LabVantage Pharma LIMS: Ensuring Compliance, Speed & Quality in Pharmaceutical Manufacturing

This scientific poster showcases how GPEx® Lightning enables precise, digital control of gene expression for complex biologics. By leveraging targeted integration into ~200 Dock sites and a single optimized construct, developers can fine-tune gene ratios for co-expression of enzymes, cofactors, and multi-chain proteins. Learn how this approach streamlines screening, boosts titers, and shortens timelines—even for products with unknown stoichiometry.

Digital Expression Control with GPEx® Lightning: Enabling Complex Biologics in CHO Cells

This whitepaper explores biocapacitance measurement as a process analytical technology (PAT) for real-time biomass monitoring in mammalian and microbial systems. Learn how this QbD-aligned approach enhances upstream process control, reduces reliance on post-batch testing, and supports continuous manufacturing. Three real-world applications illustrate its impact on process visibility and efficiency.

Biocapacitance as a PAT Tool: Real-Time Biomass Monitoring for Upstream Bioprocessing 

The following white paper explores how next-generation lab informatics solutions can transform the life science industry by addressing challenges like data silos, compliance risks, and manual workflows. The white paper further highlights the strategic value of cloud-based platforms integrating LIMS, ELN, and AI-driven analytics to accelerate breakthroughs, foster and enhance collaboration, and ensure data integrity. Real-world implementations show up to 40% faster data processing and improved decision-making. The paper concludes that digital, connected, and intelligent lab ecosystems are key to achieving smarter, faster, and more efficient pharma innovation.

Strategic Role of Innovative Lab Informatics for Enabling R&D in Pharma

Discover how Catalent’s GPEx® Lightning platform revolutionizes cell line development for complex biologics. This executive summary highlights how the platform enables rapid, high-titer expression of multispecific antibodies and other challenging proteins—accelerating timelines, improving production efficiency, and supporting commercial-scale manufacturing. Learn how tunable expression and digital control empower your team to overcome development bottlenecks and drive innovation in next-generation biologics.

Unlocking Speed and Scalability in Biologics: GPEx® Lightning Executive Overview

Catalent’s GPEx® Lightning platform delivers stable, high-yield cell lines with unmatched speed—achieving titers up to 15g/L for mAbs and 11g/L for bispecifics. With 25-day pool generation and up to 12 weeks saved on development timelines, this offering sheet outlines key performance metrics and benefits that make GPEx® Lightning a game-changer for biologics developers.

Accelerate Cell Line Development with GPEx® Lightning: Speed, Stability, and Industry-Leading Titers 

AI-powered prognostics used in histopathology can reveal complex patterns in tissue and cells that exceed human vision capabilities. We present how the incorporation of these models into laboratory workflows creates more objective, reproducible, and scalable processes. This affords greater diagnostic accuracy, faster turnaround times, and patient care that best fits their needs. By handling variability and subjectivity in traditional methods, this approach supports more confident prognoses and better clinical outcomes.

AI-Driven Prognostics: Predicting Patient Outcomes from Histopathology with Objective, Scalable Intelligence

Accelerating Complex Drug Development With Precision Micronization  

Diagnostic tool for predictive maintenance in lyophilizers: an anomaly detection algorithm that flags abnormal patterns to cut downtime and costs.

All Whitepapers