Whitepapers

Automated sample prep and LC–MS peptide mapping approach to characterize and quantify multiple monoclonal antibody (mAb) critical quality attributes (CQAs)

Intact and subunit antibody mass determination was streamlined using automated purification and enzymatic cleavage and deglycosylation of immobilized antibodies.

Modulating osmolality in the early stages of AAV1 upstream manufacturing, can result in improved outcomes such as overall yield, quality, reduced manufacturing costs and improved efficiencies.

Automated phosphopeptide enrichment and ion mobility mass spectrometry (IMS-MS) enables detailed analysis of structural effects of site-specific phosphorylation.

In this case study we use a model protein formulation containing silicone oil microdroplets to show how flow imaging microscopy with FlowCam can help analyze particles in biotherapeutic samples.

A completely hands-off, walk-away HCP assay analyzing 96 samples can be set up to run automatically on an Octet® RH96 instrument with results obtained in one hour.

To accelerate commercialization of biotherapeutics, organizations need to optimize processes by integrating advanced analytical tools that maximize quality, safety, and efficacy. Octet® BLI systems enable real-time, label-free analysis for the determination of kinetics, affinity, and antibody/protein quantitation. Based on Bio-Layer Interferometry (BLI), the systems enable an enviable variety of applications throughout biologics development, from early selection to validation and manufacturing. Read on to learn about the implementation in the production of biotherapeutics for titer, host cell protein analysis, residual protein detection, sialic acid content detection, potency assay development, Fab activity assay development, and more.

A more streamlined technique with reduced hands-on time using the Octet® platform. For customers who require a sensitive and robust assay for measuring small amounts of leached Protein A in antibody or Fc-fusion protein samples.

A simple UHPLC-CAD platform was developed for confident and accurate characterization of identity, purity and ratio of lipid components in lipid nanoparticle (LNP) formulations.

The coupling of FPLC to MALS not only detects but also quantitatively determines the absolute molecular weight and size of each species, including the targeted molecules, impurities, and its aggregates.

Submicron Flow Imaging Microscopy with FlowCam Nano enables researchers to detect particulate sources like API aggregation and bacterial contamination that may lead to particle agglomeration if not addressed.

Wyatt’s instruments and techniques constitute platform methods for effective product and process development, as well as quality control, of AAVs for gene therapy.

SEC-MALS identifies monomers, dimers, hexamers and higher aggregates of insulin to determine optimal formulation, storage and administration conditions.

Multi-angle light scattering, a powerful technology for biophysical characterization of biologics and LNPs, can also serve as an effective PAT tool to monitor product attributes during DSP.

SEC-MALS and CG-MALS characterize viral glycoprotein (vGP) self-association and the absolute stoichiometry and affinity of vGP:antibody interactions.

Watson-Marlow Fluid Technology Group (WMFTG), fluid path solutions provider of peristaltic pumps and single-use component, outlines the results of a study which makes comparisons between the semi volatiles extractables profile of post-cured and non post-cured samples of its Pumpsil platinum-cured silicone tubing.

This white paper presents the characterization of protein-DNA complexes using two complementary multi-angle light scattering techniques, SEC-MALS and CG-MALS.

Light scattering quantifies key attributes of lipid nanoparticle gene vectors such as payload, size, titer, and stability in formulation and physiological media.

This note demonstrates the use of DLS and online multi-angle light scattering with field-flow fractionation (FFF-MALS) for characterizing retrovial viral vectors.

Dynamic and static light scattering are applied to show that the choice of heating rate significantly impacts thermostability measurements of an IgG.

SEC-MALS quantifies biophysical attributes of mRNA including molar mass, percent aggregates, Rg and Rh, and how they are affected by formulation and storage conditions.

Measurement of the diffusion interaction parameter versus temperature by dynamic and static light scattering provides comprehensive analysis of protein stability.