Navigating the Global Manufacturing Supply Chain
As the strategic value of emerging markets increase, pharmaceutical companies increase their R&D and manufacturing investments.
Sterilizing with Nitrogen Dioxide
Room-temperature sterilization using nitrogen dioxide gas benefits parenteral drugs.
Advancing analytical testing and instrumentation for biopharmaceuticals
Instrument manufacturers and testing service providers are offering improved tools to biologic charaterization.
The Role of Analytical Science in Implementing Quality by Design
The authors present topics discussed and conclusions that resulted from the PDA QbD workshop.
Relevance Regained
Companies risk drowning in alphabet soup if the latest three-letter acronym improvement strategy isn't clearly linked to business strategy.
Isolation of Pharmaceutical Impurities and Degradants Using Supercritical Fluid Chromatography
The authors demonstrate that using supercritical fluid chromatography offers distinct advantages in speed and in clean isolation of the desired peaks.
Adhering to ICH Q7 for GMPs
FDA's requirements for API manufacturers in regards to ICH Q7.
Nanoparticles: Facilitating Targeted Drug Delivery in Cancer Therapy
Engineering nanoparticles with optimal properties for use in cancer therapies.
Conforming to the IPEC CoA Guide
Past IPEC-Americas excipient qualification committee chairs highlight changes to the IPEC guide on certificates of analysis for bulk excipients.
Europe and the United States to Negotiate a Free-Trade Agreement
Discussions are underway as the pharmaceutical sector calls for greater consistency in the global monitoring of GMP compliance and quality testing of APIs and finished medicines.
Regulatory Roundup
A roundup of regulatory news from across the global pharmaceutical industry.
The Lifecycle Change of Process Validation and Analytical Testing
Industry experts discuss the effect FDA's 2011 process validation guidance has had on industry.
Advances in PAT for Parenteral Drug Manufacturing
Applying quality-by-design and process analytical technology facilitates process understanding and control of various operations in lyophilization.
Catching Up
QbD paradigm advances process understanding in development and manufacturing.
Product Spotlight: Automation/IT/Process Control
New product reviews for March 2013, featuring automation, IT, and process control systems.
Measuring API Particle Size Distribution
Visual mapping can provide a particle-size distribution estimate.
Vaccine Innovation Yields New Products and Processes
Vaccine development is benefiting from manufacturing advances and support for global health.
Outsourcing Nontraditional Protein Expression Systems
Growth is seen in outsourcing of insect- and plant-cell-based bioproduction expression systems.
Foam Granulation
The authors review developments in wet granulation using a twin-screw extruder.
Report from Brazil March 2013
Brazil's major vaccine producer innovates with stem-cell research.
Pharmaceutical Technology, March 2013 Issue (PDF)
Click the title above to open the Pharmaceutical Technology March 2013 issue in an interactive PDF format.
