Waters Corporation

This executive summary examines how field-flow fractionation coupled with multi-angle light scattering (FFF-MALS) characterizes lipid nanoparticles (LNPs) as regulatory expectations from FDA, EMA, and USP converge on a shared set of critical quality attributes. It walks through how FFF-MALS resolves particle size, molar mass, and payload distribution in a single non-destructive run, and includes a case study comparing two authorized mRNA vaccines. Readers will see how size-resolved analysis uncovered differences in payload distribution that bulk-average methods missed.

This custom eBook examines how advanced analytical characterization is changing biosimilar development following the FDA's October 2025 draft guidance. It covers modern SEC separations for biosimilar antibodies, LC-MS and MAM workflows for protein characterization and attribute monitoring, and the role of multi-angle light scattering (MALS) in biosimilar approval. A closing Q&A with Matthew A. Lauber, PhD, of Waters Corporation, explores how integrating these complementary techniques builds a more complete, regulatory-ready picture of biosimilarity.

Learn how key attributes such as encapsidation, aggregation, potency, purity, and genome integrity influence AAV quality and what analytical strategies are needed to characterize them with confidence.

See how CDMS accurately characterizes AAV reference materials and generates robust data to support development, comparability, and QC workflows.

Simultaneously measure aggregates, capsid titer, genome titer, molecular weight, size, and empty/full ratio from a single analysis.

Monitor AAV enrichment as it happens to improve process understanding, increase consistency, and reduce manufacturing risk.

Move beyond inferred measurements and gain direct insight into the viral vector quality attributes that drive efficacy, safety, and manufacturing confidence.

Discover how direct mass measurement reveals viral vector heterogeneity and provides a more complete understanding of capsid populations and product quality.

Directly distinguish empty, partial, full, and overfilled capsids while detecting additional impurities in a single analysis.

One workflow. More insight. Advanced LC-MS brings your data together

Webinar Date/Time: Thu, Aug 6, 2026 11:00 AM EDT

As biopharmaceutical pipelines diversify, laboratories must deliver reliable, high-quality data across increasingly complex sample types. Download this eBook to explore how next-generation liquid chromatography (LC) systems are enabling robust, flexible bioanalysis through real-world QC applications.

From method concept to routine QC, analytical scientists must balance innovation with scalability, compliance, and reproducibility. This eBook explores how next-generation liquid chromatography (LC) systems are helping bridge that gap. Through three real-world examples you’ll see how modern LC platforms support confident decision-making across the entire analytical lifecycle.

By allowing developers to bypass comparative efficacy studies when advanced analytics are successful substitutes, the FDA draft guidance avoids one of the most expensive steps, potentially cutting years from timelines and expanding patient access. For developers though, the burden doesn’t disappear; it shifts directly from clinical trials to analytical testing.

CDMS is reshaping the characterization of complex biotherapeutics by enabling precise analysis of large, heterogeneous biomolecular complexes and gene therapy vectors. This article explores how CDMS enhances resolution in quality assessments across biotherapeutic development and structural biology research—surpassing the capabilities of conventional analytical techniques.

Explore how next-generation high-performance liquid chromatography (HPLC) systems are elevating biopharmaceutical analysis. This eBook showcases innovations in size-exclusion chromatography (SEC), method updates, and proven approaches to increase efficiency, consistency, and resolution in the lab.

Application Notebook highlighting Liquid Chromatography techniques commonly used for monitoring Critical Quality Attributes (CQAs) in Bioprocessing Applications

Webinar Date/Time: Thursday, December 11th, 2024 at 11:00 AM EST

Webinar Dates/Times: Session 1 (EU): Wednesday, May 17th, 2023 at 2pm BST | 3pm CEST | 9am EDT Session 2 (NA): Wednesday, May 17th, 2023 at 1pm EDT | 10am PDT | 6pm BST Session 3 (APAC): Thursday, May 18th, 2023 at 12pm JST | 11am CST | 11pm EDT

Read a compelling, detailed Case Study about how an innovation partnership with Waters Corporation enhanced Alcami’s capacity, efficiency, and compliance-readiness for their pharmaceutical manufacturing and analytical services to differentiate their offerings and drive business growth.

Webinar Date/Time: Thu, Mar 9, 2023 11:00 AM EST

Using the BioAccord LC-MS System and an Ambr® 15, we developed an analytical method for rapid mAb glycoform confirmations and mAb purity assessments. This unique method is high throughput capable and has the potential to be a fully automated platform for mid-process intraday monitoring of CQAs.

Wednesday, December 1st, 2021 at 11 am EST | 10 am CST | 8 am PST Learn how to accelerate therapeutic mAbs workflows by automating analysis of critical quality attributes (CQAs) such as Fc glycosylation, oxidation, C-terminal lysine clipping, and glycation.

October 4, 2021 at 3pm BST | 10am EST | 4pm CEST Join global industry and regulatory experts as they discuss current hot topics in extractables and leachables (E&L) testing for pharmaceuticals, biopharmaceuticals and medical devices.

Learn tips for efficient analyses of mAb charge variants, at both the intact and subunit level, using ion-exchange chromatography (IEX) and detection via mass spectrometry (MS). Gain insight on tools and tactics for accurate quantitation and cleaner spectra with less undesired adduct noise or super charging. Live: Wednesday, Dec. 4, 2019 11am EST | 8am PST | 4pm GMT | 5pm CST On demand available after airing until Sept. 10, 2020 Register free

In this webcast, learn about the development of a fast and robust CQA monitoring method based on multi-attribute monitoring principles using a compact, compliance-ready LC-MS system. The presentation will demonstrate how the method can be easily transferred from development to manufacturing through commercial product lifecycle management. Live: Tuesday, Sept. 10, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after airing until Sept. 10, 2020 Register free