Pharmaceutical Technology January 2018

January 2018 | Volume 42, Issue 1
Pharmaceutical Technology January 2018 Issue
Cover Story
Will business decisions and drug pricing policies help or hinder science and drug approval advances in 2018?
Features
Abuse-deterrent opioid formulations generally fall into two categories: the first is based on a physiochemical abuse-deterrent approach and the second combines the opioid with an antagonist.
The development of new packaging solutions that are fit for drugs of the future requires close collaboration between the pharmaceutical manufacturer and its packaging suppliers and machine vendors.
Measurements by a drone-based online pressure monitoring system help identify weak points in the filling line, enabling the process to be optimized.
Glass and plastic are well established primary packaging materials for the pharmaceutical industry but they both have their advantages and disadvantages.
The authors offer recommendations for permissible daily exposures and concentration limits of elemental impurities for dermal drug products.
Brexit-related challenges cast shadows on prospects for the European bio/pharma market in 2018, but optimism may let some sun shine through.
Process validation is an extension of biologics development processes.
Pharmaceutical companies and contract manufacturing organizations report lack of readiness for the US Drug Supply Chain Security Act serialization deadline.
A review of 2017 advancements from the Open-SCS working group with Charlie Gifford, group technical director.
Everyone may not be ready for the deadline, but open standards based on GAMP and GS1 will soon be released; more companies are also leveraging what they’ve learned from serialization to improve overall efficiency.
The Industrial Internet of Things can be used in the bio/pharmaceutical industry to monitor equipment health, optimize processes, and enable modular facilities.
Proper selection and installation optimizes fluid system performance.
Closures that protect solid-dosage drugs and the capping equipment that applies them have new product-protecting features.
Regulatory Watch
The repercussions of EMA’s relocation and Brexit will continue to be the dominant regulatory issue throughout 2018.
Policy makers look to boost generic drugs, curb opioid abuse, and maintain incentives for innovation.
Peer-Reviewed Research
A new algorithm uses a statistical approach to critical process parameter assessment, allowing for faster, more consistent, and less subjective critical process parameter quantification, visualization, and documentation.
API Synthesis and Manufacturing
FDA looks to achieve near-record level of new drug approvals following slowdown in 2016.
Outsourcing Outlook
The industry will see an impact from financing, M&As, advanced therapies, generic drugs, and the retail market in 2018.
From the Editor
Bio/pharma professionals manage expectations amid industry uncertainty.
Ask the Expert
Enterprise-wide processes, procedures, and systems are the keys to data integrity and peace of mind, according to Siegfried Schmitt, PhD, principal consultant at PAREXEL.
Product Spotlight
By Pharmaceutical Technology Editors
Ross, Charles & Son’s four-gallon model PDDM-4 planetary dual disperser is suited for vacuum operation, mixing thick slurries and highly-filled pastes. Ross, Charles & Son’s four-gallon model PDDM-4 planetary dual disperser is suited for vacuum operation, mixing thick slurries and highly-filled pastes.
By Pharmaceutical Technology Editors
The Wilden Quattroflow QF10k size pump from PSG, a Dover company, has been designed to fill the gap between the existing QF4400/5050 and QF20k pump sizes.
By Pharmaceutical Technology Editors
Sterile-molded filling assemblies from AdvantaPure are suited for single-use vial and syringe filling.
By Pharmaceutical Technology Editors
SupaPore Junior cartridge filters from Amazon Filters are suited for low flow up to 2m3/Hr of fluids and 100Nm3/Hr of gas processes, and are available in 2.5- and 5-in. sizes.
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