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Pharmaceutical Technology-10-02-2015
Pharmaceutical Technology
Identifying Powder Properties that Define Process Performance
October 02, 2015
Troubleshooting
38
10
Multi-faceted powder characterization, including measurement of dynamic properties, can be used to correlate powder properties and process performance to support equipment selection, optimization, and troubleshooting.
Parenteral Packaging Advances
October 02, 2015
Packaging Forum
38
10
Manufacturers of parenteral drugs face challenges to increase efficiency, control particulates, control extractables and leachables, and eliminate product/package interactions; new containers and packaging equipment offer increased options.
Serialization Shake Out
October 02, 2015
Regulatory Watch
38
10
The complexity of new packaging regulations laid out in the Falsified Medicines Directive could threaten the existence of smaller pharma and packaging companies.
Investigating Biologics
October 02, 2015
Ask the Expert
38
10
Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss performing investigations of biological products.
Advances in Fluorination Chemistry for API Synthesis
October 02, 2015
API Synthesis and Manufacturing
38
10
Safer solid reagents and new coupling chemistry are important developments.
Regulatory Considerations for Alcohol-Induced Dose Dumping of Oral Modified-Release Formulations
October 02, 2015
Features
38
10
This article looks at the current status of alcohol-induced dose dumping of modified-release formulations and the need for regulatory harmonization in handling this challenge.
Small-Molecule API CMOs Are Thriving
October 02, 2015
Outsourcing Outlook
38
10
Despite emergence of biologics, small-molecule APIs benefit from industry growth.
Modular Platform for Agitator Bead Mill Optimizes Grinding
October 02, 2015
Product Spotlight
38
10
The Alpha modular machine platform from Netzsch is designed to mount different grinding systems on the same base platform as appropriate for a defined drive capacity.
Self-Contained Laboratory Homogenizer Prepares Injectable Drugs
October 02, 2015
Product Spotlight
38
10
GEA’s Pony NS2006L is a self-contained, high-pressure laboratory and pilot plant homogenizer for product development of advanced fluid applications.
Microfluidics Systems Designed for Flow-Chemistry Experiments
October 02, 2015
Product Spotlight
38
10
The flexible Dolomite Flow Chemistry Systems from Dolomite Microfluidics can be configured to suit different applications.
Control Systems
October 02, 2015
Product Spotlight
38
10
Ross SysCon’s UL-rated and CE-marked control systems are custom-designed for industrial processes such as mixing, pumping, chemical dosing, dilution, heat exchange, separation, drying, and waste treatment.
Evolving to Meet Industry Changes
October 02, 2015
Guest Editorial
38
10
In the development of biopharmaceuticals and pharmaceuticals, the line is blurring.
Stretching Product Value through Reformulation Strategies
October 02, 2015
Cover Story
38
10
New formulations that enhance bioavailability, optimize drug-delivery profiles, reduce dosing frequency, or improve patient experience have the potential to deliver quicker returns on investments than developing a completely new drug.
Characterization and Formulation Screening of mAb and ADCs by High-Throughput DLS
October 02, 2015
Features
38
10
Leveraging Change for Continuous Process Improvement
October 02, 2015
Features
38
10
Managing change and overcoming employee resistance and fear requires a proactive approach.
Rethinking Limits in Cleaning Validation
October 02, 2015
Peer-Reviewed Research
38
10
An integrated approach can improve the efficiency of cleaning validation studies.
Pharmaceutical Technology, October 2015 Issue (PDF)
October 02, 2015
Issue PDF
38
10
Click the title above to open the Pharmaceutical Technology October 2015 issue in an interactive PDF format.
FDA Faces Controversy Over Quality Metrics and Biosimilars
September 15, 2015
Regulatory Watch
38
10
Manufacturers challenge details in new policies designed to promote access to important therapies.