Whitepapers

A two-step mAb purification process was developed, tested, and intensified. Increased process productivity, while exhibiting robust impurity clearance and high yield, was achieved.

A two-step mAb purification process was developed, tested, and intensified. Increased process productivity, while exhibiting robust impurity clearance and high yield, was achieved.

This customer note demonstrates the implementation of native SEC-MS using the Vanquish Duo UHPLC system.

Transferring from a conventional batch mode to a multi-column chromatography (MCC) process significantly increases the productivity of the Fab fragment capture.

This customer note will demonstrate the suitability of SEC for a fast and reproducible evaluation of adeno-associated virus (AAV) product titers

A 2-step platform to purify Pertuzumab is developed, using 1 mL and 5 mL pre-packed columns. Then, scale-up is demonstrated using 50 and 200 mL pre-packed columns.

This white paper summarizes information around chromatography resin variability, providing support for developing robust purification bioprocesses.

This White Paper covers all aspects surrounding AAV vectors including the challenges associated with their manufacturing and explores analytical methods for quality control.

Using a pre-packed column platform enables seamless scale-up for downstream process purification. We demonstrate that neither the capacity of the packed resin nor the separation efficiency is affected when increasing the column volume.

The goal of this paper is to introduce and support the use of osmolality in the Downstream Ultrafiltration/Diafiltration (UF/DF) process steps in the mAb workflow.

The goal of this paper is to introduce and support the use of osmolality in the Downstream Ultrafiltration/Diafiltration (UF/DF) process steps in the mAb workflow.

Using a pre-packed column platform enables seamless scale-up for downstream process purification. We demonstrate that neither the capacity of the packed resin nor the separation efficiency is affected when increasing the column volume.

The 5’ capping is a CQA for mRNA vaccines and therapeutics, and needs to be fully characterized. Learn a sensitive, robust LC-HRAM-MS/MS method for identification and quantitation of 5’ cap.

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.

Combining high performance protein A capturing and a single polishing step on a salt-tolerant anion exchange resin, downstream costs were reduced by 45% in this Tosoh 2-step process for mAb purification.

In this paper, we present an alternative targeted metabolite profiling approach using high resolution accurate mass (HRAM) mass spectrometry with full scan analysis.

Wastewater monitoring has been widely adopted by scientists to effectively detect and monitor infectious pathogens. Methods of detection and surveillance for SARS-CoV-2 are outlined in this paper and can be adapted for other pathogens.

Efficient virus recovery and impurity removal are challenges for purification of viruses such as H1N1. In a single purification step, Nuvia HP-Q AEX Resin resulted in excellent recovery and impurity removal.

Bridging Anti-CHO HCP Antibodies from Two 3rd Generation Cygnus CHO HCP ELISA Kits by AAE-MS

Bridging Anti-CHO HCP Antibodies from Two 3rd Generation Cygnus CHO HCP ELISA Kits by AAE-MS

An effective, high recovery method for purification of a DMT-on oligonucleotide and the removal of a DMT-group from an oligonucleotide in a single HIC purification step is described.

AAE and MS integration enables comprehensive HCP analysis, facilitates process development, and helps determine whether your HCP ELISA is fit for purpose of process monitoring and product lot release.

Combining high performance protein A capturing and a single polishing step on a salt-tolerant anion exchange resin, downstream costs were reduced by 45% in this Tosoh 2-step process for mAb purification.

The Synergy Tube is a BCT specifically designed to optimize nucleic acid recovery and cancer tumor cells (CTC) from the point of blood draw. The Synergy Tube and proprietary stabilizer dramatically improve the quantity and quality of these components for downstream genetic diagnostics.

ValPlus™ provides pharmaceutical manufacturers increased confidence in the cleanliness of the tubing products they use in critical applications. This whitepaper describes ValPlus™ testing protocols, results obtained, and value to manufacturers.

AAE and MS integration enables comprehensive HCP analysis, facilitates process development, and helps determine whether your HCP ELISA is fit for purpose of process monitoring and product lot release.

AAE and MS integration enables comprehensive HCP analysis, facilitates process development, and helps determine whether your HCP ELISA is fit for purpose of process monitoring and product lot release.

ValPlus™ provides pharmaceutical manufacturers increased confidence in the cleanliness of the tubing products they use in critical applications. This whitepaper describes ValPlus™ testing protocols, results obtained, and value to manufacturers.