Peer-Reviewed Research

Latest News

May 1st 2014

Regulatory Requirements for Viral-Challenge Studies: Influenza Case Study

By Bruno Speder

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

April 1st 2014

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

By Munir N. Nassar, Sangita Chandrasekharan, Vikram Sadineni

March 1st 2014

Determining CriticalityProcess Parameters and Quality Attributes Part III: Process Control StrategiesCriticality throughout the Lifecycle

By Mark Mitchell

February 1st 2014

Dilution-Free Protein Concentration Measurement for High Protein Concentration Samples

By Kannappan Veeraragavan, PhD, Lyn Watson

January 1st 2014

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

By Mark Mitchell

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

ByMark Mitchell

December 1st 2013

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

Metacomplex Formation and Binding Affinity of Multivalent Binding Partners

BySophia Kenrick,Daniel Some

November 1st 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

ByNeyda Hernández Caso,Roxana Hernández González,Hector Santana Millan,Vivian Pujol García,Virgilio Bourg,Alexey Llopiz Arzuaga,Alexis Musacchio Lasa,Julio César Sánchez García

October 1st 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.

Peer-Reviewed Research

Latest News

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

Metacomplex Formation and Binding Affinity of Multivalent Binding Partners

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

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