Analytics
Latest News
August 11th 2025
The scaled adoption of cell and gene therapies demands a new era of agile, precise, and efficient quality control methods. Manufacturers and diagnostic partners must collaborate to create innovative, compliant testing strategies that preserve product integrity, meet tight timelines, and deliver life-saving treatments faster.
Biologics Quality Control: The Growing Need for Accessible Proteomics
There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.
More News
Toward a Generic Approach for Stress Testing of Drug Substances and Drug Products
February 2nd 2005The Impurity Profiling Group reviews stress testing according to regulatory guidance documents. The authors emphasize what should be considered for late clinical phases and for registration application dossiers.
Comparison of EP "Heavy Metals" Test with USP "Conductivity" Test
January 2nd 2005Comparative studies of the US Pharmacopeia (645) "Conductivity" and the European Pharmacopeia "Heavy Metals" tests were conducted to demonstrate that the USP method can determine the presence or absence of heavy metals in process water samples.
Acceptable Analytical Practices for Dissolution Testing of Poorly Soluble Compounds
December 2nd 2004This article provides guidance for developing dissolution testing for poorly soluble compounds. It is the second of a series of articles based on material from a 2003 PhRMA workshop about acceptable analytical practices.
A reliable method for producing highly purified water.
October 1st 2004This article describes the quality of highly purified water and its applications, addressing why ultrafiltration (UF) is being used as a downstream purification process. It aims to show that UV is a real alternative for producing pyrogen-free water. This method allows essential cost savings compared with distillation and guarantees a higher safety than other membrane methods such as reverse osmosis.
Physicochemical Approaches to Enhancing Oral Absorption
September 1st 2004This article reviews various physicochemical approaches that may be employed to enhance absorption following oral administration of solid dosage forms in humans. This article also examines strategies based on capitalizing or neutralizing physiological processes.
The Introduction of Qualitative Rapid Microbiological Methods for Drug-Product Testing
September 1st 2004FDA recently approved the first PAT applications for the introduction of rapid microbial testing of drug products and pharmaceutical-grade waters. Officials from FDA and GlaxoSmithKline worked together to ensure the appropriate scientific evaluation of the methods. Team members report on the successful validation approach and identify technical issues to be considered for the future.
