IT: The application of information technology in process development and pharmaceutical manufacturing - Pharmaceutical Technology

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PharmTech Europe

IT
Mobile technology, wireless monitoring systems, RFID. LIMS and electronic notebook systems. Automation, QBAS, & process analytical technology. Service-oriented architecture & integration. Risk management and CAPA.

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

November 1, 2011

Pharmaceutical Technology

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.

NMR Reaction-Monitoring as a Process Analytical Technique

November 1, 2011

Pharmaceutical Technology

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.

The Advantages Of A Web-Based System

November 1, 2011

Pharmaceutical Technology Europe

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.

Evaluating the Bioequivalence of Antibody–Drug Conjugates

November 1, 2011

Pharmaceutical Technology

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

Analytical Applications

November 1, 2011
Pharmaceutical Technology

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

GE Healthcare to Invest $1 Billion in Oncology

September 22, 2011

ePT--the Electronic Newsletter of Pharmaceutical Technology

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.

Testing for Glass Flakes in Pharmaceutical Vials

September 21, 2011

Equipment and Processing Report

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.

ISPE to Publish Updated Sterile-Product Manufacturing Guide

September 15, 2011

ePT--the Electronic Newsletter of Pharmaceutical Technology

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.

Verification through Telecommunication

September 2, 2011

Pharmaceutical Technology

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

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
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