Pharmaceutical Technology, Nov 1, 2012 - Pharmaceutical Technology

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PharmTech Europe

Pharmaceutical Technology, Nov 1, 2012
Articles
A Novel Process for Developing Fully Human Monoclonal Antibodies
By Brian Schram , Matt Howard , Marjorie Curet , Rachel Kravitz, PhD , Voula Kodoyianni, PhD
The authors describe a process for generating high affinity, fully human antibodies in culture.
Moisture Matters in Lyophilized Drug Product
By Leu-Fin Lin, PhD , Richard Bunnell, PhD
Using an alternate moisture-generation method may provide more accurate data for regulatory submissions.
Developing a Comprehensive Approach for Preventing Metal Contamination of Pharmaceutical Products
By Lorraine Mercurio , Eldon Henson
This discussion aims to outline an approach to metal contamination prevention that should achieve a level of control acceptable to all stakeholders.
Combining Spectroscopy with Automated Imaging: A New Analytical Solution to Meet Regulatory Requirements for Inhaled Products
By Carl Levoguer
New systems that combine Raman spectroscopy with automated imaging support the efficient gathering of such data, including information concerning size and shape distributions for individual components within a formulation.
Tools for Enabling Process Analytical Technology Applications in Biotechnology
By Rakesh Mendhe , Anurag S. Rathore , Ira S. Krull
In this paper, the authors review the various analytical methods that can enable use of PAT.
Nuclear Magnetic Resonance as a Bioprocessing QbD Application
By F.C. Girard
The author discusses current expectations in bioprocessing and lays a framework for using NMR to enhance a QbD approach.
Analytical Applications
By Patricia Van Arnum
Developing analytical methods and performing related testing is crucial for ensuring the quality of a pharmaceutical product.
Determination of Higher Order Structure and Hydrogen Deuterium Exchange by LC–MS
By St. John Skilton
Hydrogen deuterium exchange by mass spectrometry is a powerful analytical approach that can be used to map higher order structures of proteins.
Using a Systematic Approach to Select Critical Process Parameters
By Thomas A. Little
Critical process parameters (CPPs) and their associated process controls are crucial to drug development and process validation and to the evaluation of every manufacturing unit operation.
Improving Technology Transfer
By Justin Neway
This article focuses on the growing need for effective data management in the life sciences industry—especially among smaller pharmaceutical manufacturers.

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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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