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

Steven W. Baertschi, PhD is a senior research scientist at Eli Lilly and Company.

Saji Thomas, is with Par Pharmaceuticals;

Dilip R. Choudhury, PhD,* is with Allergan and can be reached at choudhury_dilip@allergan.com

Robert H. Seevers, PhD, is with Eli Lilly and Company.

John Bobiak, PhD, is with Bristol-Myers Squibb

M. J. Skibic, PhD, is with Elli Lilly and Company

Kim Huynh-Ba is the Technical Director of PHARMALYTIK.

Articles

A two-day workshop on the "science behind pharmaceutical stability" was held in conjunction with the Annual Meeting of American Association of Pharmaceutical Scientists (AAPS) on Oct. 21-22, 2011 in Washington, DC.

AAPS Workshop Summary

To support global stability practices, fundamental basics must be in place.

Stability Program Management

This article introduces"mean kinetic relative humidity" for evaluating the impact of humidity variability.

Mean Kinetic Relative Humidity: A New Concept for Assessing the Impact of Variable Relative Humidity on Pharmaceuticals

Ira S. Krull is a professor emeritus of chemistry and chemical biology at Northeastern University.

Rakesh Mendhe is from Biocon Ltd., India.

Anurag S. Rathore is a professor in the Department of Chemical Engineering at the Indian Institute of Technology Delhi,  Tel. +91.9650770650, asrathore@biotechcmz.com.

In this paper, the authors review the various analytical methods that can enable use of PAT.

Tools for Enabling Process Analytical Technology Applications in Biotechnology

New systems that combine Raman spectroscopy with automated imaging support the efficient gathering of such data, including information concerning size and shape distributions for individual components within a formulation.

Combining Spectroscopy with Automated Imaging: A New Analytical Solution to Meet Regulatory Requirements for Inhaled Products

Hydrogen deuterium exchange by mass spectrometry is a powerful analytical approach that can be used to map higher order structures of proteins.

Determination of Higher Order Structure and Hydrogen Deuterium Exchange by LC–MS

This discussion aims to outline an approach to metal contamination prevention that should achieve a level of control acceptable to all stakeholders.

Developing a Comprehensive Approach for Preventing Metal Contamination of Pharmaceutical Products

Richard Bunnell, PhD, is general manager at SGS Life Sciences. richard.bunnell.com

Using an alternate moisture-generation method may provide more accurate data for regulatory submissions.

Moisture Matters in Lyophilized Drug Product

The authors describe a process for generating high affinity, fully human antibodies in culture.

A Novel Process for Developing Fully Human Monoclonal Antibodies

This article focuses on the growing need for effective data management in the life sciences industry-especially among smaller pharmaceutical manufacturers.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes