Whitepapers - BioPharm International

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Whitepapers

Analysis and Control of Particles in Biopharmaceuticals

July 29, 2014

A key challenge for companies developing biologics is the control of particles in the final formulation. Managing product contamination from intrinsic and extrinsic particles, and protecting patients from the associated risk, is increasingly important.

Charge and Interaction Analysis for Predicting Antibody Formulation Stability

April 29, 2014

Combined measurements of net charge and kD were made in order to understand the difference between two formulations with different stability behavior. While they have approximately the same net charge, their stability is dominated by the secondary effects of asymmetric charge distributions and hydrophobic residues.

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.

Analysis of Synthetic Cannabinoids from Whole Blood for Forensic Toxicology Using Ostro Sample Preparation Plates and CORTECS UPLC Solid-Core Columns

June 24, 2014

Analysis of Synthetic Cannabinoids from Whole Blood for Forensic Toxicology using Ostro Sample Preparation Plates and CORTECS UPLC Solid-Core Columns

Simple and Sensitive Sub-visible Particle Classification for Biopharmaceuticals with Micro-Flow Imaging

June 24, 2014

Micro-Flow Imaging (MFI) provides accurate and sensitive detection of sub-visible particles and protein aggregates in biopharmaceuticals. Even better, MFI can classify particle populations. This application note takes you through how easy it is to develop custom particle filters to get more accurate and sensitive discrimination between the particles in your protein formulations.

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.

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.

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.

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