There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.

Biologics Quality Control: The Growing Need for Accessible Proteomics

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.

Emerging Therapies Drive Analytical Advancements

Effective analytics will eliminate failures, deviations, and non-conformances.

 Analyzing Exabytes

Topic

Articles

The companies will develop a software-connected pipetting system for improved reproducibility and traceability in life-science laboratories.

Andrew Alliance, Sartorius to Collaborate on Pipettes

Kieran O’Connor is Analytical Science and Technology senior chemist at SK biotek, Ireland, kieran.oconnor@sk.com. (formerly Bristol Myers Squibb)

John Wasylyk is senior principal scientist at Bristol-Myers Squibb, USA; john.wasylyk@bms.com

Bob Wethman is senior research scientist II at Bristol-Myers Squibb, USA

Ming Huang is senior research investigator I at Bristol-Myers Squibb, USA

Spectroscopic-based control methods were introduced as equivalent alternative methods, first to a gas chromatographic method to monitor an in-process solvent exchange step and second to a potentiometric titration method to release a process input material for drug substance manufacturing. 

Spectroscopy Facilitates Lean Analysis

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

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

Paradigm Shift for Data Analysis and Interpretation

Agnes Shanley is senior editor of Pharmaceutical Technology.

When transferring a method from R&D to quality control, success hinges on discovering where “the best” and “the most reliable” intersect.

Analytical Method Transfer: Don’t Oversimplify

Melanie Zerulla-Wernitz is team leader project & service analytics,Vetter Pharma-Fertigung GmbH & Co. KG.

Novel analytical methods may help biologics manufacturers respond to stricter regulations on particulate matter.


Analysis of Sub-Visible Particles

Formulatrix’s FLO i8 and Flow Axial Seal Tip liquid handlers offer automated transferring.

Liquid Handlers for Automated Lab Workflows

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

Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

Outsourcing of analytical testing and processes can help bio/pharmaceutical companies expand their product profiles. 

Utilizing Analytical Services for Success in Innovation

Pharmaceutical Technology spoke with John Pirro, senior director of large molecule bioanalysis at WuXi AppTec, which provides anti-drug antibody (ADA) and neutralizing antibody (Nab) assay development, validation, and sample analysis services, about best practices to ensure that biologics are safe and effective.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes