Pharmaceutical Technology June 2017

June 2017 | Volume 41, Issue 6
Pharmaceutical Technology June 2017 Issue
Cover Story
As cost pressures mount as a result of multiple biologics being developed for the same indication, manufacturers can harness process efficiencies to maintain the value of legacy products.
Peer-Reviewed Research
In this study, the authors describe a forensic microscopy approach to characterize particles that were visually observed during stressed stability testing of an ophthalmic solution formulation.
Supply Chain
The author discusses upcoming serialization and transaction data collection regulations including the US Drug Supply Chain Security Act, the European Union Falsified Medicines Directive, and the EU Delegated Regulation.
Serialization and complementary authentication technologies are needed in order to meet DSCSA and FMD regulations.
Outsourcing Outlook
Although widespread adoption of continuous bioprocessing has been slow, some processes have been an exception.
Formulation
Modern air jet milling can be used to investigate the feasibility of micronization as a solubilization approach in formulation development.
Statistical Solutions
This column presents a data case study of a laboratory refrigerator and its qualification performance over five days, with important lessons for using average and individual results, as well as user requirements.
Features
By Pharmaceutical Technology Editors
The past several months have seen new product releases and updates made to already available laboratory equipment.
Industry experts discuss best practices for dissolution testing of poorly soluble, immediate-release, and controlled-release formulations and the different analytical approaches used.
Follow guidelines for E&L studies of an orally inhaled and nasal drug product formulation in its delivery device.
The authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.
Single-use systems demonstrate advantages over stainless-steel systems for biopharmaceutical manufacturing facilities.
Regulatory Watch
Approval of breakthrough therapies requires expedited quality assessment.
API Synthesis and Manufacturing
Efficient synthesis of complex cannabinoids is possible while avoiding marijuana cultivation.
Guest Editorial
New reports indicate that drug prices are slowing compared to other healthcare costs.
Ask the Expert
Informing your clients of possible changes in equipment is imperative when upgrading a laboratory, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
Product Spotlight
By Pharmaceutical Technology Editors
The Easy Control Box from Mettler Toledo connects any lab sensor and pump to make real-time measurement and controlled dosing available to non-experts.
By Pharmaceutical Technology Editors
The Ross PowerMix Planetary Dispersers with PLC Recipe Controls from Ross, Charles & Son deliver batch-to-batch consistency in the mixing of high-solids, high-viscosity applications.
By Pharmaceutical Technology Editors
The SMARTDAC+ GX series panel-mount type paperless recorder from Yokogawa Electric Corporation comes with new functions, including sampling intervals as short as one millisecond and the control and monitoring of up to 20 loops.
By Pharmaceutical Technology Editors
The Robotic Pulsed Light Sterilizer (RPLS1) from Steriline uses pulsed light technology for ready-to-use nest sterilization and can sterilize tubs of syringes, vials, and cartridges.
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