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Pharmaceutical Technology-12-02-2015
Pharmaceutical Technology
Achieving Balance in Sterile Product Manufacturing
December 02, 2015
Peer-Reviewed Research
39
12
Microorganism lethality requirements for process validation must always be balanced with the need to protect product integrity and patient safety.
Preventing Room Pressurization Failures
December 02, 2015
Features
39
12
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.
Determining Biosimilarity
December 02, 2015
Troubleshooting
39
12
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
39
12
FDA confirmed quality focus while Congress moved to bolster biomedical innovation.
Why Training Matters
December 02, 2015
Features
39
12
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.
Fixed-Dose Combinations
December 02, 2015
Formulation
39
12
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.
GMP Challenges for Advanced Therapy Medicinal Products
December 02, 2015
Regulatory Watch
39
12
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
39
12
Employers have work to do to improve job satisfaction and retain qualified workers.
Outlook Bright for Branded and Generic Active Ingredients
December 02, 2015
API Synthesis and Manufacturing
39
12
A strong API market is expected in 2016 despite fewer new drug approvals.
Mapping a Career Path Forward in Bio/Pharma
December 02, 2015
Cover Story
39
12
Bio/pharma employee dissatisfaction with pay and progress may direct some to new career pathways.
CMO Investors Have More Money Than Places to Spend It
December 02, 2015
Outsourcing Outlook
39
12
CMO industry consolidation may be frustrated by a dearth of attractive assets.
Market Access Outlook for Canada
December 02, 2015
Global Market Report
39
12
The author provides an overview of the key aspects of the current Canadian pharmaceutical market.
Litigation and Manufacturing Hurdles Block US Biosimilars Market Success
December 02, 2015
Features
39
12
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.
Crafting Standard Operating Procedures
December 02, 2015
Ask the Expert
39
12
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.
Optimizing Semisolid Dosage Forms
December 02, 2015
Features
39
12
Quality by design, in-vitro release testing, and modern analytical methods are improving understanding and control of these complex formulations.
Facing Crucial Career Choices
December 02, 2015
Cover Story
39
12
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.