Build your biopharma development and manufacturing knowledge base with the latest whitepapers, application notes, posters, and other educational resources from biopharma industry suppliers.

AAE Empowers HCP Identification by MS

Jared Isaac, Eric Bishop and Ken Hoffman, Cygnus Technologies, LLC

Antibody affinity extraction (AAE) and mass spectrometry (MS) integration enables comprehensive host cell protein (HCP) analysis, facilitates process development, and helps determine whether your HCP ELISA is fit for purpose of process monitoring and product lot release.

2D-LC Analysis of Complex Peptones

Sonja Krieger, Agilent

This application describes the analysis of complex peptones. Excellent chromatographic performance was achieved using 2D-LC with active solvent modulation.

FcR Affinity Chromatography of a Therapeutic Antibody

Tosoh Bioscience LLC

This application note demonstrates that the TSKgel FcR-IIIA-NPR affinity column provides fast assessment of biologic activity and glycoform patterns of antibodies.

Advanced Analytical Approaches for Accelerated Development of Gene Therapy Products

BioAnalytix

Download the White Paper and learn how detailed characterization can guide successful development of gene therapy products.

Is Your In-House Strategy Ready for the Uncertainties of Biologic Drug Development?

John Ward, vice-president, Engineering, Thermo Fisher Scientific

The pharmaceutical industry’s past reliance on blockbuster drugs has evolved to include developing drugs that treat the needs of smaller patient populations. These drugs most often come in the form of biologics, which are an increasingly larger share of new drug approvals in the past decade—from 10% to 27%.

Pipetting Ergonomics

Sartorius

Good pipetting ergonomics requires proper tool selection and optimized working environment. This whitepaper explores many published studies and other factors related to pipetting ergonomics.

Multidimensional scale-up of a mAb capture step using ÄKTA pilot 600

GE Healthcare

In this work, a multidimensional scale-up of a mAb capture step is demonstrated. Equivalent mAb recovery and purity was achieved, showing a robust and scalable process.

Understanding 21 CFR Part 11/Annex 11 Compliance

Bob Voelkner, Don DiPalma, LabVantage Solutions Inc.

Learn how regulators define temporary memory and how to maintain data integrity. Find out what to look for in a LIMS for 21 CFR Part 11 and Annex 11 compliance.

Opportunity to Mitigate Risk with ValPlus™ Certification

Tony Perovsek, Saint-Gobain

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.