Pharmaceutical Technology August 2017

August 2017 | Volume 41, Issue 8
Pharmaceutical Technology August 2017 Issue
Cover Story
FDA’s Emerging Technologies Team (ETT) team chair Sau Lee describes the reasons for the team and its structure.
Lawrence Yu, Deputy Director, Office of Pharmaceutical Quality at FDA’s Center for Drug Evaluation and Research (CDER), shares insights with Pharmaceutical Technology.
Systems that discourage continuous improvement threaten pharma innovation, quality, and supply. Can the industry break through this deadlock?
Features
Safe and effective drug targeting with ADCs requires careful selection of drug, antibody, and linker.
Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.
Statistical methods and novel indices can be used to monitor and benchmark variability, and guide continuous improvement programs in late-stage drug development.
Characterization of the product and process is key for process development and scale-up of topical drug manufacturing using a QbD approach.
Peer-Reviewed Research
The author describes how to establish acceptance limits for acceptance value (AV) data for process validation batches, typical characteristics of AV distributions, and how to derive relevant constants for AV control charts in annual product review and continued process verification reports.
Regulatory Watch
FDA urges manufacturers to seek fast approval of “high-need” generics and targeted therapies. 
API Synthesis and Manufacturing
Media manufacturers are focused on reducing risk, improving quality and consistency, and managing costs.
Outsourcing Outlook
Despite some progress, the industry is still in a wait-and-see mode regarding the administration, Congress, and FDA.
From the Editor
Amid contentious debate about “fake news,” peer-review papers offer vital, objective insight.
Ask the Expert
The review of batch records creates a story of the materials, manufacturing, and packaging involved in the production of bio/pharmaceuticals, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
Product Spotlight
By Pharmaceutical Technology Editors
The VENTILUS LE series for production-scale applications from Romaco offers three versions: LE-D for drying processes; LE-G for granulating fine solid particles; and the LE-C for coating them.
By Pharmaceutical Technology Editors
The VersaMix Multi-Shaft Mixer from Ross, Charles & Son is designed for large-scale production and enables repeatable batch processing of high-volume viscous applications.
By Pharmaceutical Technology Editors
Sartorius Stedim Biotech has expanded its range of single-use membrane chromatography solutions with Sartobind Cassettes, a pod-like modular system for commercial applications in both capture and polishing.
By Pharmaceutical Technology Editors
Watson-Marlow Fluid Technology Group (WMFTG) has expanded its range of peristaltic cased pumps for upstream and downstream bioprocessing tasks.
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