Pharmaceutical Technology May 2017

May 2017 | Volume 41, Issue 5
Pharmaceutical Technology May 2017 Issue
Cover Story
Under US regulations, such as the Medicare Access and CHP Reauthorization Act of 2015 (MACRA), part of any US physician’s reimbursement will be based on patient outcomes.
Value-based medicine is putting patients at the center of pharmaceutical R&D and forcing the industry to move from treatment to prevention.
Outsourcing Outlook
CMOs may be gaining as strategic partners to large bio/pharma companies, but they have a much harder path to navigate.
Packaging Forum
Robotic fill/finish systems reduce human intervention, improve flexibility, and allow more gentle handling of containers.
From The Editor
New study will reveal bio/pharma practices and performance on quality issues.
API Synthesis and Manufacturing
Advances in chemical synthesis are enabling greener, more cost-efficient processes for API manufacturing.
Formulation
Transdermal and inhaled/nasal delivery provide alternative routes of administration for macromolecules.
Features
The author discusses the impact of prefilled syringe product contact materials and the filling and stoppering process on protein aggregates.
Solid-phase extraction has several advantages over liquid/liquid extraction for extractables and leachables studies.
Peer Reviewed
In this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs.
Troubleshooting
Learn how to prevent common causes of product loss.
Regulatory Watch
Many pharmaceutical companies are sceptical about IDMP despite the business benefits and its contribution to patient safety.
Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.
Ask the Expert
By Pharmaceutical Technology Editors
Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to gain benefits from interactions with industry associations.
Product Spotlight
By Pharmaceutical Technology Editors
The FPB-1P5 sanitary lab mixer is the newest addition to Eirich Machines’ OptimaBlend Fluidizing Blender family of horizontal batch mixing systems.
By Pharmaceutical Technology Editors
The portable Flexible Screw Conveyor from Flexicon can be tilted and rolled to serve multiple functions.
By Pharmaceutical Technology Editors
The LogTag UTRID-16 Data Logger System from CiK Solutions GmbH includes a built-in USB connector, automatic PDF report generation, and six-level multi-alarm display.
By Pharmaceutical Technology Editors
Ross Engineering’s ASME tanks are custom built to serve a wide range of applications and processing requirements.
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