Analytical Methods Articles - BioPharm International

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Analytical Methods Articles

Quality by Design in the CMO Environment

December 1, 2007

How the authors used design of experiments and quality by design principles to develop a hydrophobic interaction chromatography step.

A History of the OOS Problem

November 1, 2007

Contrary to popular belief, the out-of-specification problem started years before the Barr Decision.

Applications of MVDA in Biotech Processing

October 1, 2007

Multivariate data analysis can help biotech manufacturers deepen their process understanding.

Protein Therapeutics and the Regulation of Quality: A Brief History

October 1, 2007

Regulatory agencies have evolved along with the biotechnology industry to define quality standards.

Process Chromatography: Five Decades of Innovation

October 1, 2007

Low-pressure process chromatography could not have developed without immense efforts to resolve scale-up issues in both column design and matrix stability.

Vaccine Characterization Using Advanced Technology

August 2, 2007

With the advent of high-resolution mass spectrometers and highly sensitive MS instruments, vaccine characterization has entered a new phase.

Separation & Purification: Endotoxin Reduction Using Disposable Membrane Adsorption Technology in cGMP Manufacturing

May 1, 2007

Membrane-based chromatography technologies sometimes offer advantages over resin-based technologies.

Chromatography: A Two-Column Process To Purify Antibodies Without Protein A

May 1, 2007

This flexible setup minimizes the number of purification process steps, buffers, and process components.

Analytical Testing to Support Biopharmaceutical Products

April 2, 2007

A tremendous amount of analytical testing is required to support a biopharmaceutical product from discovery, development, and clinical trials, through manufacturing and marketing. Numerous methods are used to fully characterize large molecules because of their complexity—characterizing them is significantly more difficult than it is for small molecules. Biopharmaceuticals are produced via living systems, i.e., E. coli, yeast, or mammalian cells, which require additional testing matrices.

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