Pharmaceutical Technology-12-02-2015

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

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.

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

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

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.

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.

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.

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

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

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

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

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

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.

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.

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

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.