Biologics Quality Control: A Critical Component Of Development And Production

INSIGHTS on BIOLOGICS QUALITY CONTROL

• Mission: Control Strategies For Effective Bioburden And Aseptic Control

  Determining the appropriate bioburden control strategy can be challenging. This eBook covers differing objectives for bioburden control, parameters to guide filter selection and optimization, industry trends, and evolving expectations.

• A Practical Guide To High-Performance Liquid Chromatography

  This practical guide on all aspects of high-performance liquid chromatography (HPLC) method development will help you make it through the maze of HPLC options.

• Optimizing LC-MS For Biopharmaceutical Analysis

  In this eBook, scientific experts discuss newer, faster, and more efficacious strategies for peptide mapping and analysis of biotherapeutic products.

• Making MS-Based Glycan Analysis Easier

  Recent technological advances in mass spectrometry based methods have made it easier to overcome the challenges of glycoprotein analysis.

• Progress In LC-MS-Based Metabolomics Techniques

  Get updated on recent and current advances in metabolome analysis by mass spectrometry with this introduction to the different approaches and technologies.

• Tips To Improve Size-Exclusion Chromatography For mAbs And ADCs

  In this article, we will explore tips to improve the method of size-exclusion chromatography (SEC), which is often used to measure monomer/aggregate and fragment content of mAbs and ADCs.

• RNA Interference - From Single Gene Studies To Whole Genome Screens

  Endoribonuclease-prepared siRNAs (esiRNAs) are able to overcome the limitations of RNAi. Learn about esiRNAs, their advantages over standard siRNAs, and ways this technology is utilized in different research fields.

• Key Requirements To Ensure Patient Safety In The Development And Production Of Viral Vaccines

  Gain insight into the issues and obstacles faced by pharmaceutical companies, the current regulatory framework surrounding viral vaccines, and how one company is preparing for the next outbreak.

• Comparison Of Supel™ BioSPME 96-Pin Device To Rapid Equilibrium Dialysis Technique For Determination Of Plasma Protein Binding

  Here, we review a technology that has been demonstrated to significantly reduce the time required for protein binding determination when compared with the rapid equilibrium dialysis method.

• Workflow For Antibody Aggregate And Fragment Analysis

  Characterizing mAb aggregate and fragment formation during drug formulation and establishing a suitable quality control process is essential. Learn about a complete workflow for antibody aggregate and fragment quantification.

• LC-MS/MS Method To Analyze 20 Amino Acids

  The wide-ranging polarities spanning across all 20 amino acids makes analysis challenging. Learn about a LC-MS/MS method for analyzing all 20 amino acids, without derivatization, utilizing a carbon LC column.

• Workflow For High-Throughput Glycoprofiling Of Rituximab

  Proper characterization of therapeutic mAbs is essential for ensuring drug safety and efficacy. Discover a complete SEC-MS workflow, developed to enable rapid glycoprofiling of mAbs in cell culture supernatants.

• Middle-Up Mass Analysis Of Protease Digested Cetuximab

  Explore a complete reversed phase UHPLC-MS workflow, developed to simplify middle-up mass analysis of an immunoglobulin G antibody, from the antibody purification, proteolysis, and reduction to its UHPLC-MS analysis.

• Quick Tips For An Easy Protein Extraction

  Learn how to select the right lysis reagent, protect protein from degradation, reduce the viscosity of your sample, and determine the μg of protein needed per your final assay.

BIOLOGICS QUALITY CONTROL SOLUTIONS

• Overcome Biologics Development & QC Challenges

  Although biologics are becoming more and more popular, their development and quality control remains extremely challenging. Here, we provide some useful insight to address challenges as early as possible.

• LC-MS Resource Guide

  Explore a selection of proven tools and consumables that meet the requirements of scientists who primarily use the LC-MS technique for drug analysis, biomolecule separation, and analytical assays.

• Separate Proteins, Peptides & Glycans Faster With BIOshell™ U/HPLC Columns With Fused-Core® Technology

  In the development of “large molecule” biotherapeutics, the BIOshell™ superficially porous particle (SPP) packed columns aid research to better understand the subtleties of the molecule being developed.

• Supel™ BioSPME 96-Pin Devices For Fast And Simple Plasma Protein Binding Studies

  Developed for plasma protein binding determination and free fraction analyses, the Supel™ BioSPME 96-Pin Devices greatly improve upon the speed and simplicity of current sample preparation techniques.

• Chiral HPLC Columns For Chiral HPLC And LC-MS Separations

  Explore chiral HPLC columns for versatile and robust chiral HPLC and LC-MS separations. Use this guide to choose the right one for your successful chiral LC analysis.

• Supel™ BioSPME 96-Pin Devices

  Explore a range of devices for free fraction analyses and determination of plasma protein binding that make sample preparation easier and faster, with complete phospholipid removal and proven reproducibility.

• Microbial Culture Media For Quality Control Of Non-Sterile Products

  Using the correct media is critical to ensure microbiological quality. Explore a portfolio of culture media and substances for sample preparation, microbial enumeration tests, and tests for specified microorganisms.