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.

MedImmune Acquires Definiens

November 4, 2014

MedImmune enters into an agreement to acquire the image analysis and data mining company.

Developing Representative Sampling Plans for Development, Problem Solving, and Validation

November 1, 2014

The ability to define a scientifically justified and statistically sound sampling procedure is a fundamental skill in modern systematic drug development.

Coupling Light Scattering with Size-Exclusion Chromatography

October 1, 2014

Adding light scattering to size-exclusion chromatography (SEC) can maximize the benefits of SEC.

Application of Quality by Design to Viral Safety

October 1, 2014

A quality-by-design approach that defines potential viral contaminants of source materials can be used to achieve viral clearance.

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.

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.

Marrying Big Data with Personalized Medicine

August 1, 2014

Data analytic strategies can help companies capitalize on personalized medicine.

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.



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