Analytics

Gayatri C.Patel, M.Pharm, PhD, is associate professor in the Department of Pharmaceutics & Pharmaceutical Technology, Ramanbhai Patel College of Pharmacy at the Charotar University of Science and Technology, Changa Campus, Changa- 388 421, Anand, Gujarat, India, gayatripatel.ph@charusat.ac.in, +91 2697 265162.

Chintan Patel is a researcher in the Department of Biotechnology, Zydus Research Centre, Cadila Healthcare Ltd., Ahmedabad, Gujarat, India. 

Sanjay Bandyopadhyay, PhD, is vice-president in the Department of Biotechnology, Zydus Research Centre, Cadila Healthcare Ltd., Ahmedabad, Gujarat, India

Articles

It is important to address manufacturing problems associated with the shorter shelf-life of pegylated L-asparaginase (pegaspargase) upon long-term storage in the form of a solution. 

Degradation Pathways: A Case Study with Pegylated L-Asparaginase

Beverly Nickerson, PhD, is an associate research fellow in analytical research and development at Pfizer Inc., Eastern Point Road, Mail Stop 4086, Groton, CT 06340, tel. 860.441.0668, fax 860.715.8004, beverly_nickerson@groton.pfizer.com.

Anster Charles was a graduate student at the University of Missouri’s Chemistry Department, Columbia, MO.

Carlos Lee works for Lyndra Therapeutics, Watertown, MA.

Gail Johnson works for Pfizer Worldwide Research and Development in Groton, CT.

John Warzeka works for Pfizer Worldwide Research and Development in Groton, CT.

Laboratory testing found that a novel approach reduced the time required for sample preparation from hours to minutes. This article summarizes test methods and results.

Speeding Sample Preparation and API Extraction from Solid Oral Dosage Formulations

Waters debuted a range of new TA Instruments innovations and the BioAccord System at Pittcon 2019 in Philadelphia, PA, on March 17–21, 2019.

Waters Showcases New TA Innovations and Biopharma System at Pittcon 2019

Microsaic Systems showcased its new MiD ProteinID point-of-need mass spectrometer at Pittcon in Philadelphia, PA, from March 18–21, 2019.

New Protein Characterization Technique Unveiled at Pittcon 2019

Bruker highlighted new analytical systems for several industry applications, including pharma, materials science, and clinical/preclinical research.

Bruker Highlights New Analytical Systems and Applied Market Solutions at Pittcon 2019

The new automated cloud-based tool allows for the design of targeted single-cell DNA custom panels.

Mission Bio Launches Automated Cloud Tool for DNA Panels

Natalia Belikova, PhD, is analytical services director at SGS Life Sciences, Lincolnshire, IL.

Determination of sodium chloride level is critical for assessment of purity of yeast extracts. This case study demonstrates the validation of an ion chromatography method as a suitable analytical approach.

Determination of Sodium Chloride in Yeast Extract by Ion Chromatography

Luke Deters is director Biologics at Catalent Pharma Solutions, Kansas City, Missouri, USA.

HPLC coupled with charged aerosol detection is a suitable analytical technique to quantitate and characterize polysorbate-80 in therapeutic products; allowing quality assessment of raw material, content confirmation during manufacturing, and monitoring product stability.


Quantification and Characterization of Polysorbate-80 in Protein Formulations

Daniel N. Hayes is associate principal scientist at Cambrex High Point Analytical Research and Development.

Investigation of peak purity failure during HPLC method validation led to discovery of a co-eluting impurity under the main peak. Spectral analysis, including three-dimensional modelling, was used to characterize the peak, leading to the development of a new HPLC method for analysing impurity content.

Utilizing Spectral Analysis in HPLC Diode Array to Discover Impurities

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. 

Analytical Method Development