Peer-Reviewed Research - BioPharm International

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Peer-Reviewed Research
Technical articles on biopharmaceutical processing topics reviewed and accepted by the editorial advisory board of BioPharm International.

Environmental Responsibility in Chinese Biopharmaceutical Companies

August 1, 2014

Corporate environmental responsibility (CER) is on the corporate and political agenda in China. This study determined the relevance of environmental aspects for biopharmaceutical companies in China and presents a new perspective that calls for an integration of CER into the business strategy as a source of competitive advantages.

Concentrating Feed—an Applicable Approach to Improve Antibody Production

June 1, 2014

Different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture are evaluated.

Regulatory Requirements for Viral-Challenge Studies: Influenza Case Study

May 1, 2014

Review regulatory requirements and the use of viral-challenge studies in drug development.

Implications of Trace Levels of Redox-Active Metals in Drug-Product Formulation

April 1, 2014

The presence of minute amounts of chelators can help minimize the degradation of monoclonal antibodies.

Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle

March 1, 2014

This series presents a practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three stages of the process validation lifecycle. In Parts I and II, risk analysis and process characterization studies were used to assign criticality risk levels to critical quality attributes and critical process parameters, and the concept of a continuum of criticality was established. In Part III, the author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle.

Determining Criticality—Process Parameters and Quality Attributes Part II; Design of Experiments and Data-Driven Criticality

January 1, 2014

Criticality is used as a risk-based tool to drive control strategies.

Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum

December 1, 2013

Criticality is used as a risk-based tool to drive control strategies.

Metacomplex Formation and Binding Affinity of Multivalent Binding Partners

November 1, 2013

A study to investigate metacomplex formation in the hetero-association of a multivalent antigen, streptavidin (SA), and a bivalent antibody (Ab) using a composition-gradient multiangle light-scattering (CG-MALS) system consisting of a composition-gradient device, a MALS detector, and a UV/Vis absorption detector.

Definition of a Security Value Determined by Limulus Amebocyte Lysate Assay Targeting the Recombinant Human Epidermal Growth Factor

October 1, 2013

The correlation between limulus amebocyte lysate (LAL) assay and rabbit pyrogen test (RPT) targeting recombinant human epidermal growth factor (rhEGF) as active molecule was assessed.

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