Analytical Methods Articles - BioPharm International

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Analytical Methods Articles

The Lifecycle Change of Process Validation and Analytical Testing

March 1, 2013

BioPharm International spoke with industry experts about the effect FDA's 2011 process validation guidance has had on industry.

Overcoming Challenges in the Reconstitution of a High-Concentration Protein Drug Product

March 1, 2013

The authors present approaches used to reduce reconstitution time of a lyophilized high-concentration protein drug product.

Advances in PAT for Parenteral Drug Manufacturing

March 1, 2013

Applying quality-by-design and process analytical technology facilitates process understanding and control of various operations in lyophilization.

Facility Design and Operation: A Primer

February 1, 2013

NIBRT's Michael Lacey provides an overview of biopharmaceutical facility design and operation.

Automated Concentration and Diafiltration of Multiple siRNA Samples

February 1, 2013

Project: transfer a manual concentration/diafiltration process for siRNA production.

Aseptic Processing: A Primer

January 1, 2013

NIBRT's Ray O'Connor provides an overview of aseptic processing.

The Future of Biopharma

January 1, 2013

What the industry's future holds and what needs to be done to get there.

A Look Ahead at BioPharma Manufacturing and Regulation

January 1, 2013

FDA talks about the changing scope of regulatory science.

Bioanalytical Methods for Sample Cleanup

December 1, 2012

Preparation of biological samples for chromatographic analyses.

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