Analytics - BioPharm International

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Analytics
Analytical testing methods in pharma manufacturing. Chromatography, UHPLC, chiral. Near-infrared (NIR) and Raman spectroscopy. Anticounterfeiting. Dissolution testing. Cleaning validation. Extracables & leachables.

Control Strategies for Synthetic Therapeutic Peptide APIs Part II: Raw Material Considerations

April 1, 2014

USP evaluates raw materials used in the chemical synthesis of peptides.

Design of Experiments for Analytical Method Development and Validation

March 1, 2014

Design of experiment is a powerful development tool for method characterization and method validation.

Dilution-Free Protein Concentration Measurement by Absorbance at 280 nm for High Protein Concentration Samples

February 1, 2014

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

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.

Performing a Protein Purity Analysis Comparability Study

October 1, 2013

A well-designed comparability study can demonstrate the performance and advantages that can be gained when adopting a new protocol.

Identification and Quantification of Trace-Level Protein Impurities

September 1, 2013

A simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics is described.

Essentials in Establishing and Using Design Space

September 1, 2013

Knowledge of product or process acceptance criterion is crucial in design space.

Elucidating Biosimilars Characterization

September 1, 2013

Review the importance of characterization studies during biosimilars development and related analytical methods.

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