Analytics

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

Articles

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

Paradigm Shift for Data Analysis and Interpretation

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

By adapting techniques from other sciences-and exploring better tools for biologics drug development-researchers are addressing challenges of protein characterization.

Complex Protein Studies Demand Dynamic Techniques

Integration of new modeling and analytical tools with flow chemistry are notable trends.  

Efficiency Demands Drive Advances in API Labs

Access to multiple analytical techniques is essential for fully characterizing complex protein formulations.

Multiple Views Deliver Complete Characterization of Protein Particles

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

Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.

Impurity Testing

Jizhou Wang is chemist at the Division of Life-Cycle API, Office of New Drug Product, Office of Pharmaceutical Quality, Center of Drug Research and Evaluation Center, Food and Drug Administration.

Neeru Takiar is chemist at the Division of Life-Cycle API, Office of New Drug Product, Office of Pharmaceutical Quality, Center of Drug Research and Evaluation Center, Food and Drug Administration.

Huyi Zhang is chemist at the Division of Life-Cycle API, Office of New Drug Product, Office of Pharmaceutical Quality, Center of Drug Research and Evaluation Center, Food and Drug Administration.

David J. Skanchy is a senior supervisory regulatory review officer, at the Division of Life-Cycle API, Office of New Drug Product, Office of Pharmaceutical Quality, Center of Drug Research and Evaluation Center, Food and Drug Administration.

The authors survey deficiency letters issued for 190 drug master files supporting abbreviated new drug application submissions.

Characterization of Small-Molecule Drug Substances in Type II DMFs Supporting ANDAs

Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.

Experts discuss some of the emerging trends in bioprocessing in 2016, including 4D bioprinting, 2D-NMR, and the CAR-T design space.

Visions for the Future of Biopharma Manufacturing

Researchers describe a new method to compare the higher-order structure of a reference biologic with its proposed biosimilar product candidates.

The Use of 2D-NMR for the Assessment of Biosimilarity

Bruker's InsightMR software for on-line NMR analysis enables real-time data analysis and acquisition control for process monitoring.

Software Enables Real-Time Acquisition and Analysis of NMR Spectra

NMR analysis provides crucial structural information of synthesized glycans while LC-MS/MS is ideal for quantitation of free sugars in biological matrices.

Bio/Pharmaceutical Analysis, NMR