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More Efficiency with Equivalent Data: MFI 5200

September 30, 2014

Micro-Flow Imaging (MFI) is now the go-to technology for monitoring and characterizing a wide range of visible and subvisible particles and protein aggregates using particle size and morphology. This application note shows how the latest MFI system stacks up to its predecessor by cutting the hands-on time for sample analysis without any loss in functionality and performance.

Efficient, high-titer monoclonal antibody production in a fed-batch process using single-use stirred-tank and rocking bioreactor systems

September 30, 2014

MAb production in fed-batch processes with single-use Xcellerex™ XDR-200 stirred-tank and ReadyToProcess WAVE™ 25 rocking bioreactor systems. Cell expansion was performed in a 15 L rocking bioreactor culture to seed a 200 L stirred-tank bioreactor culture.

PEGylated Protein Analysis by Size-Exclusion and Reversed-Phase UPLC

September 30, 2014

The first PEGylated biotherapeutic, pegademase, which is a bioconjugate of the bovine derived enzyme adenosine deaminase and 5 KDa molecular weight (MW) polyethylene glycol (PEG), was introduced in 1990. Pegademase is used for the treatment of individuals with severe combined immunodeficiency disease (SCID).

High-Resolution Separation of a Fusion Protein

September 30, 2014

A high-resolution HIC application for the separation of fusion protein therapeutics. This application, based on protein surface hydrophobicity, allows separation of a fusion protein from a truncated version and structural isomer.

Production of Stem Cells in Single-use Vessels

September 30, 2014

In this study, the success of large clinical-scale culture of human adipose-derived mesenchymal stem cells (AdMSCs) in an industrial single-use vessel at 3.75 L working volume is demonstrated. The vessel offers a precision-controlled environment for the ideal growth of stem cells under simulated physiological conditions.

Enhanced Assurance of Supply for Single-Use Bags

August 26, 2014

Enhanced assurance of supply for single-use bags is based on material science, quality by design, and partnership with suppliers.

High-Resolution Separation of Cysteine-Conjugated Antibody Drug Mimics

August 26, 2014

Cysteine-conjugated ADC mimics are successfully separated based on their drug-to-antibody ratio (DAR) using a Thermo Scientific™ MAbPac™ HIC-10 column. Separation of ADC mimics was optimized by adjusting temperature, solvent content, and gradient.

TOYOPEARL GigaCap® Cation Exchange Resins for Aggregate Removal from Monoclonal Antibodies

August 26, 2014

Aggregate removal is a pivotal process step in the purification of monoclonal antibodies (mAbs). The removal of soluble, non-precipitated mAb aggregates is highly challenging due to their close physical and chemical similarity to the drug product itself. Ion exchange chromatography (IEC) has long been used as an effective means of removing process impurities from biological drug products. Cation exchange chromatography (CEX), in particular, has shown to be effective in separating mAb monomer from dimers and higher order aggregates. In this paper, the removal of mAb dimer and higher order aggregates from mAb monomer using TOYOPEARL GigaCap cation exchange resins is demonstrated.

Determination of Protein Molecular Weight and Size

July 29, 2014

This application note shows the determination of protein molecular weight and size, together with linear quantification using the Agilent 1260 Infinity Multi-Detector Bio-SEC Solution.

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