Peer-Reviewed Research

Latest News

October 1st 2014

Single-Use Bioreactors for the Rapid Production of Preclinical and Clinical Biopharmaceuticals

By Mikal Sherman, Christopher R. Cruz, Christel Fenge, PhD

Fed-batch processes were scaled up from traditional bench-scale bioreactors to large-scale single-use systems.

Dilution-Free Protein Concentration Measurement for High Protein Concentration Samples

ByKannappan Veeraragavan, PhD,Lyn Watson

February 1st 2014

Accurate protein concentration results can be obtained using standard spectrophotometers and commercially available short path length absorption cells.

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

ByMark Mitchell

January 1st 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

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.