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

James A. Koziol is a professor at The Scripps Research Institute, La Jolla, CA 92037, koziol@scripps.edu.

Michael A. Grossman is president of Strategic Advantage Inc., Wellesley, MA 02481, StrategicAdvantage@comcast.net.

Articles

Incorporating structural constraints into pharmacokinetic studies of iron sucrose formulations.

Analysis of Total and Transferrin-Bound Iron from Serum Samples

Russell Madsen, president, The Williamsburg Group, and member of the Pharmaceutical Technology editorial advisory board, shares his thoughts on technology innovations and regulatory implications.


Perspective: From Art to Science

Cheaper drugs are good for consumers, but cost restrictions limit drug company incentives to modernize facilities.

Perspective: Cost Constraints Hinder Innovation

Orlando LÃ³pez is an industry veteran holding several technical and management positions in different pharmaceutical and medical device companies in the areas of computer validation, IT Compliance, and IT Processes. He is a member of the Data Integrity Working Group (Institute of Validation Technology). He can be contacted at olopez6102@msn.com.

The author reviews key technological expectations of EU GMP inspectors on the integrity of e-records.

Data Integrity Expectations of EU GMP Inspectors

The company added new products to its InfinityLab LC Series which will be showcased at HPLC 2017 in Prague. 


Agilent Adds Products to InfinityLab LC Series

Sartorius Stedim Biotech combined the company’s ambr 15 bioreactor system with the Nova BioProfile FLEX2 cell culture analyzer for laboratory experiments.  


SSB Integrates Automated Cell Culture Analyzer and Micro-Bioreactor

Christopher Burgess, PhD, is managing director, Burgess Analytical Consultancy Limited, Barnard Castle, Co Durham, UK.

A case study presents important lessons for using average and individual results, as well as user requirements, when qualifying a laboratory refrigerator. 


For Lab Equipment Qualification, Data Reveal Important Story

The past several months have seen new product releases and updates made to already available laboratory equipment.


New and Updated Laboratory Equipment Optimize Efficiency

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Industry experts discuss best practices for dissolution testing of poorly soluble, immediate-release, and controlled-release formulations and the different analytical approaches used.

Understanding Dissolution Testing

S.J. Ingham is scientist at Pharmaceutical Technical Services, Bausch & Lomb (a division of Valeant Pharmaceuticals) Rochester, NY 14609.

M.L. Ciolkowski is principal scientist at Pharmaceutical Technical Services, Bausch & Lomb (a division of Valeant Pharmaceuticals) Rochester, NY 14609.

B. J. Glass is senior research scientist, all at Pharmaceutical Technical Services, Bausch & Lomb (a division of Valeant Pharmaceuticals) Rochester, NY 14609.

In this study, the authors describe a forensic microscopy approach to characterize particles that were visually observed during stressed stability testing of an ophthalmic solution formulation.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes