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Whitepapers

TOYOPEARL NH2-750F Aggregate Removal from Monoclonal Antibodies

June 24, 2014

The drive to reduce the manufacturing costs for biological therapeutics have increased the demands placed on downstream unit operations to the point where a single processing step is expected to accomplish a multitude of purification objectives. Where anion exchange resins have traditionally been used to remove DNA, endotoxin, and as a viral clearance step in the purification of monoclonal antibodies (mAbs), new ligand chemistries make it possible for anion exchange chromatography to do more. In the following paper, TOYOPEARL NH2-750F, a salt tolerant anion exchange resin from Tosoh Bioscience, is shown to be able to remove mAb dimer and higher order aggregates from mAb monomer.

Quantifying Economic Benefits of Automated Rapid Detection

May 26, 2014

Most pharmaceutical manufacturers have adopted lean initiatives within their production areas in order to survive and thrive in an increasingly competitive economy. But an often-overlooked area, quality control, has been left untouched by lean initiatives. Pharmaceutical companies can achieve maximum efficiency by evaluating and streamlining microbial quality control procedures using lean principles to automate and accelerate the work microbiologists have traditionally done manually with a rapid microbial method. Learn key components to include in a business case.

Improving Aggregate Removal from Monoclonal Antibody Feed Using High Resolution Cation Exchange Chromatography

May 26, 2014

Nuvia™ HR-S media is a new cation exchanger designed for high resolution of closely related product impurities such as aggregates. It delivers excellent resolution with a final aggregate content of <0.3% and a high recovery of >80% from a heterogeneous feed of monoclonal antibody aggregates and monomer. Aggregate content and recovery in the eluate were shown to be a function of the target conductivity measured at the end of collection.

N-linked Glycan Characterization and Profiling: Combining the Power of Accurate Mass, Reference Glucose Units, and UNIFI Software for Confident Glycan Assignments

May 26, 2014

Glycan characterization has remained a challenging aspect of biotherapeutic characterization compared to techniques such as intact mass or peptide map analysis, which most labs consider routine today. The addition of the glycan UPLC/FLR/MS workflow and use of the experimentally derived Waters Glycan GU Library within the Glycan Application Solution with UNIFI have addressed the desire for compliant-ready, automated, high-confidence glycan structure assignments by enabling rapid acquisition, review, and communication of individual glycan profile results, and the larger sets of glycan analyses used for comparability studies.

Evaluating Protein Glycosylation in Limited-Quantity Samples by HPAE-PAD

May 26, 2014

By combining HPAE-PAD analysis with acid hydrolysis and enzymatic digestion of protein glycans, information about the glycan identity as well as terminal carbohydrate linkage isomers can be determined from small amounts of protein.

TOYOPEARL® AF-rProtein A HC-650F rProtein A Ligand Leakage

May 26, 2014

This application note compares the amount of leached Protein A ligand that is present in purified monoclonal antibody, post elution, when using TOYOPEARL AF-rProtein A HC-650F, TOYOPEARL AF-rProtein A-650F, and another commercially available high capacity Protein A resin. Protein A ELISA tests specific to each resin evaluated show that the TOYOPEARL AF-rProtein A HC-650F is very stable and exhibits a markedly lower level of ligand leakage compared to the other resins tested.

Handheld Raman- Rapid Counterfeit and Substandard Medicines Detection

May 19, 2014

A study of commonly counterfeited drugs concluded that 1064nm handheld Raman rapidly distinguishes substandard pharmaceuticals; thus providing the means for immediate removal from the supply chain.

Achieving 21 CFR Part 11 Compliance with the iCE3

March 25, 2014

Rapid analysis, platform methods, and easy method development make the iCE3 ideal for analyzing biologics. In fact, these benefits have made iCE? cIEF assays one of the key assays for biologics characterization and quality control. In this application note we review the iCE3 features that simplify system start up, operation, and compliance with 21 CFR Part 11.

Fast and Efficient Peptide Mapping of a Monoclonal Antibody (mAb): UHPLC Performance Using Superficially Porous Particles

March 25, 2014

In this work, an AdvanceBio Peptide Mapping column is used to generate a rapid and highly efficient peptide map at a traditional LC system pressure. The column achieves substantial improvements in peptide mapping during very fast run times and low system pressures, while still maintaining high peak-performance efficiency.

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