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Pharmaceutical Technology-10-02-2017
Pharmaceutical Technology
Managing Potentially Potent APIs
October 02, 2017
API Synthesis and Manufacturing
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CDMOs have established strategies for handling new chemical entities with unknown biological activity.
Pharma’s Role in Puerto Rico’s Future
October 02, 2017
From the Editor
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Reeling from financial and tropical storms, Puerto Rico needs stable industry for recovery.
Starting Early is Key to De-Risking Drug Development
October 02, 2017
Cover Story
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The pharmaceutical industry is under tremendous pressure to make drug development faster and cheaper. Applying the right formulation strategy using structured and rigorous science can help avoid costly failures and re-starts, but it’s important to start from an early stage.
Formulation Strategies in Early-Stage Drug Development
October 02, 2017
Cover Story
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Applying the right formulation strategies early in the drug development process can help avoid costly late-stage failures.
Pharmaceutical Environmental Pollution and Antimicrobial Resistance
October 02, 2017
Regulatory Watch
41
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The European Commission is striving to tackle environmental pollution by pharmaceuticals as a means of curbing antimicrobial resistance.
A Closer Look at Prefilled Syringes
October 02, 2017
Features
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Choosing between presterilized and bulk sterilized prefilled syringes.
FDA User Fees Promote Manufacturing Readiness
October 02, 2017
Regulatory Watch
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Industry and FDA face new fee structures and new challenges in implementing fee initiatives.
Testing and Simulation Approaches for Single-Use Bioreactor Scale-up
October 02, 2017
Features
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Tools aid scale-up and comparison of single-use and stainless-steel bioreactors.
Up and Away, M&A
October 02, 2017
Outsourcing Outlook
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Mergers and acquisitions are positive for the CDMO industry, but there is a downside.
Making Decisions Based on Risk
October 02, 2017
Ask the Expert
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Focusing on whether the product meets its defined quality attributes should help one make reasonable, documentable, and defendable risk-based decisions, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
Lab Line for Developing Drug Implant Technology
October 02, 2017
Product Spotlight
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The Thermo Scientific Pharma mini implant line is an integrated solution built around the Thermo Scientific Pharma mini HME twin-screw micro compounder.
Low-Temperature Spray Drying for Microencapsulation
October 02, 2017
Product Spotlight
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Fluid Air’s PolarDry spray dryers use electrostatic technology, providing low-temperature spray drying, encapsulation, and selective agglomeration in the creation of particles.
Multi-Agitator System for Mixing and Dispersion Requirements
October 02, 2017
Product Spotlight
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Ross, Charles & Son’s VersaMix is a multi-shaft mixer designed for viscous applications requiring a high level of accuracy and batch-to-batch consistency.
Analytical Data System Update
October 02, 2017
Product Spotlight
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An updated version of Shimadzu’s LabSolutions analytical data system incorporates additional functions to comply with data integrity regulations, and to support development and quality inspection procedures.
Choosing Capsules: A Primer
October 02, 2017
Features
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Capsules offer certain benefits over tablets for oral-solid dosage drugs, and several types of capsules are available.
Improved Materials Enhance Parenteral Packaging
October 02, 2017
Features
41
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Manufacturers introduce innovations in glass and plastic packaging for injectables.
Is Your Tablet Hard to Swallow? Guidance Addresses Drug Tablet Design
October 02, 2017
Features
41
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EMA and FDA guidance encourages design of drug products to improve patient compliance.
Singlet Determination Revisited
October 02, 2017
Statistical Solutions
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Is there a difference between a specification and a standard?
Automated Visual Particle Inspection
October 02, 2017
Features
41
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This article discusses fully automatic inspection of glass and plastic containers and factors that affect particle detection rate.
The Real Complexity of Excipient Composition
October 02, 2017
Features
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This article seeks to promote dialogue among stakeholders to facilitate consensus regarding requirements for excipients.
How to Monitor HPMC Concentration Through Conductivity Measurement
October 02, 2017
Peer-Reviewed Research
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The authors demonstrate that a proper measure of HPMC solution concentration is its electrical conductivity rather than its viscosity.
Teaming Up for FDA Inspections
October 02, 2017
Features
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Just as FDA strengthens ties between reviewers and plant inspectors, proactive manufacturers are involving different disciplines in preparation for FDA audits.
Reinventing Lean Six Sigma for the Pharmaceutical Industry
October 02, 2017
Features
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Instead of rigidly applying statistical tools, experts suggest that pharma embrace statistical thinking, but focus on reducing variability and adding value for patients.
Six Sigma and the Path to Quality
October 02, 2017
Features
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Lawrence Yu, deputy director of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), and his FDA colleague, Michael Kopcha highlight the importance of Six Sigma approaches to continuous improvement in the pharmaceutical industry.
Pharmaceutical Technology, October 2017 Issue (PDF)
October 02, 2017
Issue PDF
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Click the title above to open the Pharmaceutical Technology October 2017 issue in an interactive PDF format.