Analytics - BioPharm International


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

Evaluating Design Margin, Edge of Failure, and Process Capability

September 1, 2014

Design space generation is encouraged in new product development.

USP Awards Analytical Research

August 15, 2014

USP awards research in analytical tools, anticounterfeiting, and dry powder inhaler products.

Analytical and Bioanalytical Testing

August 1, 2014

Review new technologies and best practices in testing for viral contamination and biosimilars; method transfer practices; data management strategies; and protein purification processes.

Marrying Big Data with Personalized Medicine

August 1, 2014

Data analytic strategies can help companies capitalize on personalized medicine.

Ensuring the Safety, Quality, and Identity of Biopharmaceutical Raw Materials

August 1, 2014

Going beyond pharmacopeial requirements is essential for the quality and safety of raw materials.

Analyzing Proteins Using SEC, MALS, and UHPLC

July 1, 2014

Light scattering analysis combined with more rapid size exclusion chromatography improves protein characterization.

Accelerated Stability Modeling

May 1, 2014

Characterization of stability performance provides a clear, statistically defendable method for determining accelerated stability.

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.



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