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Pharmaceutical Technology-05-02-2016
Pharmaceutical Technology
Forced Degradation Studies for Biopharmaceuticals
May 02, 2016
Features
40
5
The author addresses critical issues to consider prior to performing forced degradation studies and provides best practice recommendations for these types of studies.
Choosing Containment Strategies For Highly Potent APIs
May 02, 2016
Troubleshooting
40
5
Safe handling of HPAPIs requires determining exposure potential and selecting appro-priate containment strategies.
Visions for the Future of Biopharma Manufacturing
May 02, 2016
Cover Story
40
5
Experts discuss some of the emerging trends in bioprocessing in 2016, including 4D bioprinting, 2D-NMR, and the CAR-T design space.
Outsourcing of Biomanufacturing in 2016
May 02, 2016
Outsourcing Outlook
40
5
Growth may be slowing, but outsourcing activity remains healthy.
Pharmaceutical Quality: Where Do We Need to Go from Here?
May 02, 2016
Features
40
5
As the pharmaceutical industry moves toward continuous manufacturing, new documents are needed to provide flexible guidance that meets the new process requirements.
Reporting Quality Metrics to FDA
May 02, 2016
Ask the Expert
40
5
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.
Significant Revisions and Updates to the European Pharmacopoeia
May 02, 2016
Inside Standards
40
5
Revisions and updates for the 9th Edition of the European Pharmacopoeia result in changes to more than half of the content.
Upstream and Downstream Operations Can Impact Biologic API Uniformity
May 02, 2016
API Synthesis and Manufacturing
40
5
Bioprocess operations-from cell line selection to final filtration-can influence the consistency and purity of biologic drug substances.
The Value of Saving Lives
May 02, 2016
Guest Editorial
40
5
Policies for patient access to life-saving therapies must keep pace with biomedical innovation.
Practical Approaches to Tech Transfer and Scale-up of Lyophilization Processes
May 02, 2016
Features
40
5
Troubleshooting and collaboration are essential in implementing commercial lyophilization processes.
A QbD Method Development Approach for a Generic pMDI
May 02, 2016
Formulation
40
5
Application for Sirdupla Uniformity of Delivered Dose Methodology
Waking up to Track-and-Trace Benefits
May 02, 2016
Supply Chain
40
5
With deadlines only a few years away, some companies have not started serialization programs, while others are taking a tactical, short-term approach, losing out on potential business benefits.
Tackling Moisture Challenges in Solid Dosage Manufacturing
May 02, 2016
Formulation
40
5
Armin Gerhardt, associate professor of Pharmaceutical Science, Concordia University Wisconsin School of Pharmacy, discusses the effects of moisture on product quality and how to achieve good control of moisture during pharmaceutical manufacturing operations.
Penetrometer for Quality Monitoring
May 02, 2016
Product Spotlight
40
5
The penetrometer PNR 12 from Anton Paar, used for quality monitoring, features the Pharma Qualification Package--Smart PNR 12, which fulfills GMP and United States Pharmacopeia (USP) regulations and can be used to perform qualification processes.
Operator Stations Ensure Functionality
May 02, 2016
Product Spotlight
40
5
The NEMA 4X Operator Stations, from Ross, Charles & Son, include a 15-inch color touchscreen with Ethernet communications and emergency stop button with hermetically sealed contact block.
Filling and Closing System Reduces Decontamination Cycle
May 02, 2016
Product Spotlight
40
5
The FlexPro 50, from Groninger, is a modular filling and closing system designed to process vials, cartridges, and syringes, as well as vials in bulk and trays.
Ultracentrifuge Allows for Multi-Wavelength Analysis
May 02, 2016
Product Spotlight
40
5
The Optima AUC from Beckman Coulter Life Sciences is an ultracentrifuge that determines molecular weight, size shape, and polydispersity.
EU on a Mission to Boost R&D
May 02, 2016
Regulatory Watch
40
5
In a move to encourage drug development, EU regulators are offering scientific advice to companies on major efficacy, safety, and quality issues at an early stage.
Pharmaceutical Technology, May 2016 Issue (PDF)
May 02, 2016
Issue PDF
40
5
Click the title above to open the Pharmaceutical Technology May 2016 issue in an interactive PDF format.
FDA and Manufacturers Seek Safer Pain Medications
April 07, 2016
Regulatory Watch
40
5
The campaign against opioid abuse opens door to more innovative therapies.