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

Andrew Nason is an associate in the DC office of Frommer Lawrence and Haug LLP.

Kevin Murphy is a partner with the New York office of Frommer Lawrence and Haug LLP.

Articles

Can postapproval FDA filings immunize pharma companies from patent lawsuits?

Patents and Postapproval Batch Testing

A change in terminology could emphasize patient protection.

Time to Revise ICH Q9

As-found data is a crucial component of pipette calibration for laboratories that must comply with GMP regulations.

Using As-Found Data in a Pipette Calibration Program

Amy Ritter is Scientific Editor, BioPharm International and Pharmaceutical Technology. Amy Ritter joined the editorial staff of BioPharm International and Pharmaceutical Technology in 2011. She received her BA in Biology from Boston University, and holds a PhD in Neurobiology from SUNY at Stony Brook. Before joining Advanstar’s Pharm Sciences group, she worked in the preclinical pharmacology group at Merck Research Labs, and is the author of numerous peer-reviewed scientific publications.

Amy Ritter was Scientific Editor, BioPharm International.

FDA announced the availability of the guidance â€œQ11 Development and Manufacture of Drug Substancesâ€ in the Nov. 20, 2011 edition of the Federal Register.

FDA Adopts Final Version of Q11 Guidance

Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Experts share insight into extractables and leachables testing, including high-risk products, analytical testing, and regulatory requirements from FDA and EMA.

Examining the Growing Challenge of Extractables and Leachables

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.

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.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes