Pharmaceutical Technology-12-02-2015

Pharmaceutical Technology
Peer-Reviewed Research

December 02, 2015

Microorganism lethality requirements for process validation must always be balanced with the need to protect product integrity and patient safety.

Pharmaceutical Technology
Features

December 02, 2015

All openings and potential apertures for air penetration must be considered when designing a cleanroom so that the HVAC system can maintain the desired negative or positive pressure.

Troubleshooting
Pharmaceutical Technology

December 02, 2015

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

Regulatory Watch
Pharmaceutical Technology

December 02, 2015

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

Features
Pharmaceutical Technology

December 02, 2015

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.

Pharmaceutical Technology
Formulation

December 02, 2015

The advantages of fixed-dose combinations are well recognized but their formulation and manufacture can be a challenge, Stefania Barzanti from IMA Active explains why.

Regulatory Watch
Pharmaceutical Technology

December 02, 2015

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.

From The Editor
Pharmaceutical Technology

December 02, 2015

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

Pharmaceutical Technology
API Synthesis and Manufacturing

December 02, 2015

A strong API market is expected in 2016 despite fewer new drug approvals.

Pharmaceutical Technology
Cover Story

December 02, 2015

Bio/pharma employee dissatisfaction with pay and progress may direct some to new career pathways.

Outsourcing Outlook
Pharmaceutical Technology

December 02, 2015

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

Pharmaceutical Technology
Global Market Report

December 02, 2015

The author provides an overview of the key aspects of the current Canadian pharmaceutical market.

Pharmaceutical Technology

The CEO of a US-based biosimilar manufacturer explains the legal and intellectual property issues of bringing a biosimilar to market in the United States.

Ask the Expert
Pharmaceutical Technology

December 02, 2015

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.

Pharmaceutical Technology
Features

December 02, 2015

Quality by design, in-vitro release testing, and modern analytical methods are improving understanding and control of these complex formulations.

Pharmaceutical Technology
Cover Story

December 02, 2015

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.