Biopharmaceutical Analysis

Cynthia A. Challener, PhD, is a contributing editor to BioPharm International.

Articles

Mass spectrometry and automation are growing in importance for protein characterization, but further improvements are still needed.

Evolving Analytical Technology Unravels Protein Characteristics

The new filters extend column life and reduce contamination while simplifying sample preparation.

Pall Introduces Acrodisc Syringe Filters with Universal, Water-Wettable PTFE Membranes

The new chromatography columns provide enhanced separation for high order aggregates and macromolecules.

Tosoh Bioscience Introduces TSKgel UP-SW Aggregate UHPLC/HPLC Columns

The following details some of the latest tools and systems available for biopharmaceutical laboratory operations.

The Latest in the Laboratory

PPD is expanding its bioanalytical lab in Richmond, VA, to enhance its immunochemistry, biomarker, and chromatography services.

PPD Expanding Bioanalytical Laboratory Capabilities

Mario DiPaola is senior scientific director at Charles River Laboratories, Woburn, MA.

INDU JAVERI is president and CEO, CuriRx, Inc., Wilmington, MA.

Effective application of mass-spectrometry tools can optimize biosimilar analysis, reducing development time and cost.

Methods Accelerate Biosimilar Analysis

Real-time monitoring of product- and process-related impurities remains a challenge.

Analysis of Residual Impurities in Continuous Manufacturing

Valerie Theobald is director, immunoanalytical services at Charles River Laboratories. 

Jenifer Vija is scientific director, bioanalysis, at Charles River Laboratories.

Jessica St. Charles is director, laboratory sciences at Charles River Laboratories.

Christina Satterwhite, PhD, is senior director, global laboratory sciences at Charles River Laboratories. 

Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex therapeutic classes.

Emerging Therapies Test Existing Bioanalytical Methods

Dijana Hadziselimovic is laboratory manager, Technical Services, at STERIS, Saint Louis, Mo.

Elizabeth Rivera is a technical services manager at the Life Sciences Division of STERIS Corporation.

Laboratory test methods evaluate cleaning agents and cleaning process design for removing resin residues from the surfaces of non-dedicated chromatography columns systems.

Cleaning Chromatography Resin Residues from Surfaces

Leveraging vast quantities of analytical data requires digitalization and platform integration.

Biopharmaceutical Analysis: HPLC/UHPLC