Analytical Methods Articles - BioPharm International


Analytical Methods Articles

QbD for Analytical Methods

February 1, 2009

QbD for QA? Try a two-step approach

Protein Peptide Purification using the Multicolumn Countercurrent Solvent Gradient Purification (MCSGP) Process

January 1, 2009

A new method for MAb purification.

Antibody Purification Using Membrane Adsorbers

December 1, 2008

Results from a process developed for a commercial antibody.

Aggregates in MAbs and Recombinant Therapeutic Proteins: A Regulatory Perspective

November 1, 2008

FDA perspectives on specs and effective control strategies.

Plasmid DNA Recovery Using Size-Exclusion and Perfusion Chromatography

September 1, 2008

Scalable method to recover plasmid-DNA.

Avoiding the Pain of Out-of-Specification Results

June 1, 2008

Improving your quality operations by using sound statistical principles.

Harvest and Recovery of MAbs from Large-Scale Mammalian Cell Culture

May 1, 2008

A comparison of primary harvest techniques.

Coming to Biotech Near You: Quality by Design Part 1: Its Applicability in Biopharmaceuticals

May 1, 2008

The principles of QbD can be applied to biotech development and manufacturing to help resolve many common issues. QbD scientifically provides a greater understanding of the complex relationships among product quality attributes, the manufacturing process, and clinical safety and efficacy by determining the various permutations of critical input variables that will keep the product within specification.

Impact of Lot-to-Lot Variability of Cation Exchange Chromatography Resin on Process Performance

May 1, 2008

Understanding the impact on process performance.



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