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A Novel Process for Developing Fully Human Monoclonal Antibodies
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| By
Brian Schram
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Matt Howard
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Marjorie Curet
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Rachel Kravitz, PhD
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Voula Kodoyianni, PhD
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The authors describe a process for generating high affinity, fully human antibodies in culture.
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Moisture Matters in Lyophilized Drug Product
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Leu-Fin Lin, PhD
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Richard Bunnell, PhD
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Using an alternate moisture-generation method may provide more accurate data for regulatory submissions.
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Developing a Comprehensive Approach for Preventing Metal Contamination of Pharmaceutical Products
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| By
Lorraine Mercurio
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Eldon Henson
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This discussion aims to outline an approach to metal contamination prevention that should achieve a level of control acceptable to all stakeholders.
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Combining Spectroscopy with Automated Imaging: A New Analytical Solution to Meet Regulatory Requirements for Inhaled Products
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| By
Carl Levoguer
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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.
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Tools for Enabling Process Analytical Technology Applications in Biotechnology
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| By
Rakesh Mendhe
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Anurag S. Rathore
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Ira S. Krull
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In this paper, the authors review the various analytical methods that can enable use of PAT.
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Nuclear Magnetic Resonance as a Bioprocessing QbD Application
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F.C. Girard
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The author discusses current expectations in bioprocessing and lays a framework for using NMR to enhance a QbD approach.
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Analytical Applications
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Patricia Van Arnum
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Developing analytical methods and performing related testing is crucial for ensuring the quality of a pharmaceutical product.
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Determination of Higher Order Structure and Hydrogen Deuterium Exchange by LC–MS
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St. John Skilton
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Hydrogen deuterium exchange by mass spectrometry is a powerful analytical approach that can be used to map higher order structures of proteins.
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Using a Systematic Approach to Select Critical Process Parameters
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Thomas A. Little
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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.
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Improving Technology Transfer
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Justin Neway
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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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