Whitepapers

Maximize yield without sacrificing quality, safety, or consistency. Discover ILC Dover flexible engineered solutions for #biopharm and #pharm manufacturing processes

Continuous liners reduce costs, cross-contamination, and operator labor. Watch the video to see how

ILC Dover announced its launch of liquid single-use bioprocessing bags, representing the first of many new products for handling sterile liquids in the biotherapeutics and cell and gene therapy markets. This expansion continues our line of solutions designed for use across the entire biotherapeutic and pharmaceutical manufacturing workflow—from powder containment and handling to sterile liquid handling and pre-filled liquid and powder bags.

soloPURE™ is ILC Dover's closed-barrier system for sterile manufacturing - learn more.

The JetMixer™ System provides fast powder mixing and complete protection of powder properties.

Precise temperature control has a significant influence on performance and quality in chemical process engineering. The Unistat range of temperature control systems ensure accurate temperatures and stable process conditions in research laboratories, pilot plants and kilolabs worldwide.

This technical bulletin discusses major regulatory updates, introduced by the FDA and EMA, regarding nitrosamines and SGS proposed risk assessment method for compliance.

Watson Marlow Fluid Technologies Solutions (WMFTS), 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.

Improved host cell protein analysis using highly reproducible and scalable automated sample digestion and fractionation ahead of LC–MS coupled with iterative MS–MS

Automated MHC-I is associated peptide enrichment using the Agilent AssayMAP Bravo platform with large-capacity Protein A cartridges for immunopeptidomics analysis.

The AssayMAP Bravo was used to purify, digest, and clean up antibodies from 96 cell culture supernatants with high reproducibility and minimal labor prior to LC–MS.

Automated phosphopeptide enrichment from cell lysates with Fe(III)-NTA enables the identification of thousands phosphopepides with high reproducibly and selectivity.

Automated Antibody Drug Conjugate (ADC) purification and deglycosylation increases reproducibility and simplifies drug-to-antibody ratio (DAR) determination.

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.

Replace ELISA and HPLC with Octet® systems for quantitation of antibodies and recombinant therapeutic proteins. Accurate and fast assays are also easy to develop and transfer to QC and manufacturing. In this whitepaper you will learn about analyzing a full plate (96-samples) of IgG titer in as little as two minutes, assay directly in crude and unpurified samples, and automation for extending un-attended run times and high throughput analysis.

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.