Analytics

Articles

Although stability testing programs for small-molecule drugs and biologics are often perceived as similar, stability programs for biologics are far more complex.

Determining Shelf Life: Reading the Stability Testing Data

Chris Burgess, PhD, is an analytical scientist at Burgess Analytical Consultancy Limited, ‘Rose Rae,’ The Lendings, Startforth, Barnard Castle, Co Durham, DL12 9AB, UK; Tel: +44 1833 637 446; chris@burgessconsultancy.com; www.burgessconsultancy.co

A simplified process flow with associated definitions for pharmaceutical sampling and testing is proposed. 

Sampling and Testing Nomenclature for Pharmaceutical Analysis: A Simplified Approach

Inconsistent sampling and testing processes can lead to errors, resulting in data integrity issues and potentially incorrect decisions about pharmaceutical quality. 

Sampling and Testing Nomenclature for Pharmaceutical Analysis: A Review of Current Practices

Vector Laboratories has completed a $124 million cash buyout backed by Thompson Street Capital Partners and will begin an acquisition strategy to expand protein detection capabilities.

Vector Laboratories Closes $124 Million Buyout

Sunday Ndiana-Abasi is an intern pharmacist at the Department of Pharmaceutical Technology and Raw Materials Development in the National Institute for Pharmaceutical Research and Development in Nigeria.

Marlene Ekpo is a youth corp pharmacist and research assistant at the Centre for Nanomedicine and Biophysical Drug Delivery, National Institute for Pharmaceutical Research and Development, and a postgraduate student at the School of International Education, Southern Medical University, Guangzhou, Guangdong, China.

Martins O. Emeje, martinsemeje@yahoo.com, is a professor at the Department of Pharmaceutical Technology and Raw Materials Development and director of the Centre for Nanomedicine and Biophysical Drug Delivery, National Institute for Pharmaceutical Research and Development.

The potential for okra gum as a polymer candidate for new oral drug formulations was evaluated.

Evaluating Okra Gum in a Floating Tablet Formulation as a Novel Drug Delivery System

Aaron M. Robitaille is senior product marketing manager with Thermo Fisher Scientific.

Brandon J. Bills is product manager, Thermo Fisher Scientific.

Intelligent analytical tools detect impurities to help ensure the quality of small-molecule drug ingredients.

Stepping Up the Search for Unknown Impurities

Thomas A. Little, PhD, is president, Thomas A. Little Consulting and BioAssay Sciences, 12401 North Wildflower Lane, Highland, Utah 84003, USA, drlittle@dr-tom.com.

It is important to use correct organization and appropriate methods for demonstrating biosimilar comparability to support regulatory filings.

Determining Comparability of Biosimilars Through Statistical Approaches

A new membrane staining kit, ExoBrite, launched by Biotium aims to enhance the detection of exosomes through flow cytometry.

Biotium’s New Staining Kit Aims to Optimize Exosome Detection

BioMed X has partnered with Janssen to start two new research programs for autoimmune diseases and drug delivery.

BioMed X and Janssen Start Up Research Programs in Autoimmunity and Drug Delivery

Mark Rogers, PhD, mark.rogers@sgs.com, is the global scientific director for the SGS Health Science Drug Development group.

New challenges arise in extractable and leachable studies for cell and gene therapy products.

Analytical Method Development