Pharmaceutical Technology-12-02-2015

Pharmaceutical Technology

Determining Biosimilarity

December 02, 2015

Troubleshooting

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Analytical methods and functional assays are used to compare molecules and relate characteristics to quality attributes.

New Drugs and New Initiatives Shaped 2015

December 02, 2015

Regulatory Watch

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FDA confirmed quality focus while Congress moved to bolster biomedical innovation.

Why Training Matters

December 02, 2015

Features

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Investing in worker training is crucial to the success of a company. This article reviews the benefits of a robust training program in pharmaceutical bulk manufacturing.

GMP Challenges for Advanced Therapy Medicinal Products

December 02, 2015

Regulatory Watch

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Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.

The Search for Job Satisfaction

December 02, 2015

From The Editor

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Employers have work to do to improve job satisfaction and retain qualified workers.

CMO Investors Have More Money Than Places to Spend It

December 02, 2015

Outsourcing Outlook

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CMO industry consolidation may be frustrated by a dearth of attractive assets.

Crafting Standard Operating Procedures

December 02, 2015

Ask the Expert

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Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to write standard operating procedures that hold up to audits.

Facing Crucial Career Choices

December 02, 2015

Cover Story

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Intellectual challenge, job security, and opportunity for advancement contribute to employee happiness, but the ultimate prize may be a satisfactory salary for bio/pharma employees in Europe.