Whitepapers

Case study showcasing accelerated PPQ for an E. coli–expressed orphan therapy, achieving three PPQ batches in 18 months through high-compliance manufacturing.

Discover how a robust platform enables fast, high-quality bispecific antibody production by optimizing gene ratios, CLD, and analytics for purity and yield.

Discover the future of microbial expression with a platform that optimizes strain selection, expression systems, and purification methods, providing actionable insights in just eleven weeks.

This white paper explains the benefits and challenges of microbial-based fermentation for biologics, highlighting why processes often need to be custom-built for each molecule. Outlining a streamlined, cost-effective path that accelerates development from strain selection through tox material and early GMP, to reach IND and first-in-human trials faster.

Determining the optimal hybrid set-up can be challenging, with trade-offs in cost and flexibility. Our strategic framework helps you design the optimal mix for your facility.

The development of biologics, from initial molecule selection to commercial product, presents complex challenges related to stability, manufacturability, and immunogenicity. Skipping essential risk assessments can lead to costly consequences, including reformulation, reduced shelf life, additional testing, regulatory delays, or even project termination. Download this article to learn more about how a structured, data-driven developability workflow can de-risk biologics during early stages of development.

New drug modalities are reshaping formulation science

Pharmaceutical development is as much an art as it is a science, with experts working to find the best solutions and then formulating them in a manner that is universally accessible, efficacious, and sustainable. This article delves into how customized release for dispersed dosage formats enhances patient acceptance and therapeutic performance.

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.

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.

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.

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.

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.

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.

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.

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.

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

Learn how a custom ADA assay was designed, incorporating acid dissociation with the ACE method to overcome drug interference using other standardized formats.

Having a robust immunogenicity assay for accurate evaluation of ADA in animal models is important for enabling effective decision-making during development. Learn how a robust anti-drug antibody assay was developed and was capable of detection at the requisite sensitivity and enabled meaningful interpretation of PK data obtained from the preclinical animal model.

Learn the unique considerations for use of ADA assays in early development, pre-clinical and clinical settings, as well as how to generate high-quality methods at each stage to support successful development and regulatory approval of safe and effective biotherapeutic drugs.

The identification of drug metabolites is a critical step in drug development due to their impact on drug efficacy and safety. LC-MS platforms provide good selectivity and sensitivity making it the preferred technique for metabolite identification. Here, metabolite identification was performed using unique fragments from EAD and CID spectra. Fragment information from EAD and CID spectra were processed in a single result file to achieve confident structure assignment of and localization of metabolites.

Learn about the end-to-end solution for metabolite identification from method development to analysis.

Throughout drug development, it is important to characterize and quantify pharmaceutical compounds and any associated metabolites to ensure proper drug safety and efficacy. LC-MS/MS techniques are predominantly used for such analyses because they provide a comprehensive outlook and can offer a sensitive and selective approach for the quantification of compounds. However, limited deep fragment coverage and sensitivity challenge the confident identification and quantification of metabolites and drug products. Here, alternative fragmentation paired with a highly sensitive QTOF system was employed for comprehensive data collection to properly identify metabolites and quantify complex peptide therapeutics.

This technical note demonstrates the comprehensive characterization and confident identification of glucuronide metabolites from hepatocyte incubations of midazolam.