Elements of Biopharmaceutical Production Series

The editors of the longest running peer-reviewed publication in its sector have compiled the, ELEMENTS of BIOPHARMACEUTICAL PRODUCTION SERIES for anyone involved in or planning to start process development, characterization and/or validation activities.

The series presents opinions and viewpoints from industry experts, led by Anurag Rathore—Director, Amgen Inc.— on issues that are routinely faced in process development and manufacturing of biopharmaceuticals.

ELEMENTS of BIOPHARMACEUTICAL PRODUCTION SERIES includes information on:

1. Basic principals and practices of scale-up in preparative chromatography.

2. Process validation—how much and when to do it.

3. Cost analyses for generating optimal, robust, and economical commercial processes.

4. Optimization, scale-up and validation: Issues in filtration of Biopharmaceuticals.

5. Scale-down modeling,and qualification.

6. Efficiency Measurements for Chromatography Columns.

7. Applying Process Analytical Technology (PAT) to biotech unit operations to project gains in consistency and operational efficiencies.

8. Resin screening to optimize chromatographic separations.

“The trick to process validation, these industry experts argue, is to understand that it is a process that stretches through the whole product life cycle. Some secrets of success: Take a team approach; focus on the timing of the various stages of validation; avoid some common mistakes; and build your documentation as you go.”