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

High Molecular Weight Protein Analysis Made Simple

Andrea Tu and Patricia Piatti, Protein Simple

Resolve the challenges of analyzing high molecular weight proteins with Simple Western. It automates all steps and removes the need for transfer. Highly reproducible, small sample size, and quantifiable results.

Released N-linked Glycan Analysis Using the Glycan Application Solution with UNIFI

Waters

The vast majority of biotherapeutics are glycosylated. Glycans attached to the proteins play a critical role in the serum half-life, efficacy, and safety of the biotherapeutic drug. Released glycan analyses are traditionally done using either optical or MS only analytical systems, and the data interpretation can be very challenging due to a lack of integrated analytical systems. In recent years, Waters has launched a series of innovative analytical tools to address the challenges faced in N-glycan analysis. This technology brief demonstrates two fit-for-purpose glycan analysis workflows for comprehensive N-linked glycan profiling and structural elucidation within the Waters Glycan Application Solution with UNIFI.

Analysis of Antibody-Drug Conjugates Using SEC-MS

Sonja Schneider, Agilent

This Application Note describes the analysis of antibody-drug conjugates by SEC-MS using the Agilent 1290 Infinity II LC system with an Agilent 6530 Accurate Mass Q-TOF LC/MS system.

High Sensitivity Quantification of Infliximab in Rat Plasma Using a Fast, Standardized Kit-Based Approach

Mary Lame, Hua Yang, Sherri Naughton, and Erin Chambers, Waters

This application note describes the fast, sensitive quantification of infliximab from rat plasma using the ProteinWorks eXpress Digest Kit and Protocol. The ProteinWorks eXpress Digest Kit was successfully used to purify infliximab from a typical set of standard curve and QC samples in rat plasma. A limit of quantification of 10 ng/mL was readily achieved, while maintaining excellent linearity and single digit precision.

Taking Advantage of High Capacity Protein A: An Economic Comparison of the Resin Cost Per Gram of Antibody Produced

Tosoh Bioscience LLC

With pressures mounting to reduce production costs at many companies, and protein A being the most expensive resin used in mAb purification, the use of a high capacity protein A resin can significantly impact the overall cost of doing business. This report details how using a high capacity protein A resin will reduce production costs, on a per-gram produced basis, for companies that implement its use in their chromatography platform.

Analysis of Antibody-Drug Conjugate Through the Characterization of Drug-Antibody Ratios Using an Agilent 1290 Infinity Binary LC System Coupled to an Agilent 6550 iFunnel Q-TOF

Ravindra Gudihal and Jing Chen, Agilent

The reversed phase analysis of an ADC using an Agilent 1290 Infinity LC system coupled to an Agilent 6550 iFunnel Q-TOF with Agilent LC columns can be extensively used to reproducibly generate accurate DAR values on both intact and reduced ADCs with excellent performance.

Ensure Biologic Product Integrity from Plant to Patient

UPS

Three executives from UPS talk about the hurdles to entering unfamiliar territory when it comes to getting a new pharmaceutical product into market and what’s the best approach in capturing the market when it comes to distribution.