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The US Pharmacopeia (USP) proposes to lower the maximum permissible limits of trace elements in pharmaceuticals and recommends that impurities be measured through automated instrumentation-based methods. The proposed regulations specify inductively coupled plasma–mass spectrometry (ICP–MS) and inductively coupled plasma–optical emission spectrometry (ICP–OES) as the techniques of choice. This article discusses the benefits of ICP–MS and ICP–OES for the accurate detection of trace elements in pharmaceutical products, in compliance with the proposed USP chapters.

Addressing Elemental Impurity Limits with ICP–OES and ICP–MS

The authors discuss the analytical methods and related testing for bioequivalence studies of ADCs.

Evaluating the Bioequivalence of Antibody–Drug Conjugates

A Technical Forum Moderated by Patricia Van Arnum, featuring contributions from PerkinElmer, BioTools, Chiral Technologies, Shimadzu Scientific Instruments, GE Analytical Instruments, and Waters.

Analytical Applications

The authors describe the benefits of nuclear magnetic resonance (NMR) compared with traditional monitoring techniques. They also discuss how NMR reaction monitoring provides a new process analytical technology tool for industry.

NMR Reaction-Monitoring as a Process Analytical Technique

Dr. Fred Jordan, CEO at AlpVision SA, explains how web-based server solutions can aid anticounterfeiting strategies and why such systems are seeing increased uptake.

The Advantages Of A Web-Based System

GE Healthcare, the health business of General Electric, will dedicate $1 billion of its total R&D budget during the next five years to its technologies for manufacturing biopharmaceuticals and for cancer research. Part of the money will go toward expanding the company's cancer-diagnostic and molecular-imaging capabilities, as well.

GE Healthcare to Invest $1 Billion in Oncology

Glass flaking or delamination can result in a failed quality-assurance test, thus bringing production to a halt and causing substantial revenue loss. If glass delamination remains undiscovered, it can pose a serious contamination risk to the drug product and a potential health risk to the public.

Testing for Glass Flakes in Pharmaceutical Vials

The International Society for Pharmaceutical Engineering will soon publish an update for its guide to sterile-product manufacturing facilities. The new publication will replace the original guide and contain practical information about technological advances in sterile manufacturing.

ISPE to Publish Updated Sterile-Product Manufacturing Guide

Hallie Forcinio is packing editor for Pharmaceutical Technology and Pharmaceutical Technology Europe, editorhal@sbcglobal.net.

Smartphones could become the product-authentication tool of choice. Contains online bonus material.

Verification through Telecommunication

Using information technology tools to enhance process understanding helps reduce variability that can affect speed to market.

Data and Artificial Intelligence