Analytics

Articles

FDA is collecting public comments on a draft guidance for bioanalytical method validation developed by ICH.

FDA Announces Draft Guidance for Bioanalytical Method Validation

Using Lean, Six Sigma, and other Op Ex practices is helping one contract development and manufacturing organization (CDMO) increase efficiency and optimization.

Applying Operational Excellence to Improve Injectable Pharmaceuticals Production

Cambrex has announced the completion of its new facility at its Karlskoga site in Sweden that combines new laboratories for process and analytical development.

Cambrex Completes New Facility at Swedish Manufacturing Site

Ioscani JimÃ©nez del Val is assistant professor at the School of Chemical & Bioprocess Engineering, University College Dublin, Ireland

Close collaboration between academic and industrial groups is vital to ensuring glycosylation models are fit for deployment.


Leveraging Computational Models of Glycosylation for Biopharma QA

Leachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.

A Study of Leachable Silicone Oil in Simulated Biopharmaceutical Formulations

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

Empty and prefilled syringes must pass a range of quality control tests.

Test Methods and Quality Control for Prefilled Syringes

Agnes Shanley is senior editor of Pharmaceutical Technology.

More manufacturers are embracing MAM, which simplifies biopharmaceutical product quality testing, and facilitates the measurement and monitoring of critical quality attributes.

Using the Multiple Attribute Method for Process Development and Quality Control

Andrew Johnson is analytical specialist with Gaylord Chemical Co, LLC.

Ashley Jones is analytical chemist with Gaylord Chemical Co, LLC.

In Karl Fischer analysis, sulfur trioxide can react with DMSO, invalidating test results. The authors evaluated different instruments and methods, described in this article, to minimize the impact on results.

Testing for Water in DMSO: Exploring Alternatives to Volumetric Karl Fischer Analysis

The Quartic Platform is a new, AI-powered smart manufacturing platform that can be integrated into legacy facilities and manufacturing processes.

Quartic.ai Introduces AI Platform for Process Manufacturing Operations at INTERPHEX 2019

Elizabeth Rivera is a technical services manager at the Life Sciences Division of STERIS Corporation.

Dijana Hadziselimovic is a technical services laboratory specialist for the Life Sciences Division at STERIS.

Laboratory test methods evaluate cleaning agents and cleaning process design for removing resin residues from the surfaces of non-dedicated chromatography columns systems.

Analytical Method Development