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Pharmaceutical Technology-08-02-2017
Pharmaceutical Technology
Using QbD in Topical Drug Manufacturing
August 02, 2017
Features
41
8
Characterization of the product and process is key for process development and scale-up of topical drug manufacturing using a QbD approach.
Targeting Drug Delivery with ADCs
August 02, 2017
41
8
Safe and effective drug targeting with ADCs requires careful selection of drug, antibody, and linker.
Optimizing Cell-Culture Media
August 02, 2017
API Synthesis and Manufacturing
41
8
Media manufacturers are focused on reducing risk, improving quality and consistency, and managing costs.
Gottlieb Tackles Opioids, Drug Costs, and Innovation
August 02, 2017
Regulatory Watch
41
8
FDA urges manufacturers to seek fast approval of “high-need” generics and targeted therapies.
Larger Peristaltic Pumps Allow Scale-Up
August 02, 2017
Product Spotlight
41
8
Watson-Marlow Fluid Technology Group (WMFTG) has expanded its range of peristaltic cased pumps for upstream and downstream bioprocessing tasks.
A Look at Batch Record Review
August 02, 2017
Ask the Expert
41
8
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.
Drying, Granulating, and Coating System Offers Modularity
August 02, 2017
Product Spotlight
41
8
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.
Heavy-Duty Multi-Agitator Mixer
August 02, 2017
Product Spotlight
41
8
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.
CDMOs: New Administration, New Frontier
August 02, 2017
Outsourcing Outlook
41
8
Despite some progress, the industry is still in a wait-and-see mode regarding the administration, Congress, and FDA.
Single-Use Systems Expand Scale of Chromatography
August 02, 2017
Product Spotlight
41
8
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.
Targeting Drug Delivery with ADCs
August 02, 2017
Features
41
8
Safe and effective drug targeting with ADCs requires careful selection of drug, antibody, and linker.
Just the Pharma Facts, Please
August 02, 2017
From the Editor
41
8
Amid contentious debate about “fake news,” peer-review papers offer vital, objective insight.
Breaking Through Obstacles to Improve Drug Manufacturing
August 02, 2017
Cover Story
41
8
Systems that discourage continuous improvement threaten pharma innovation, quality, and supply. Can the industry break through this deadlock?
The Role of Quality Standards for Biomanufacturing Raw Materials
August 02, 2017
Features
41
8
Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.
Inside FDA’s Emerging Technologies Team with Team Chair, Sau Lee
August 02, 2017
Cover Story
41
8
FDA’s Emerging Technologies Team (ETT) team chair Sau Lee describes the reasons for the team and its structure.
Encouraging Innovation at FDA: An Interview with CDER’s Lawrence Yu
August 02, 2017
Cover Story
41
8
Lawrence Yu, Deputy Director, Office of Pharmaceutical Quality at FDA’s Center for Drug Evaluation and Research (CDER), shares insights with Pharmaceutical Technology.
Establishing Acceptance Limits for Uniformity of Dosage Units: Part Two
August 02, 2017
Peer-Reviewed Research
41
8
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.
A Continuous Improvement Metric for Pharmaceutical Manufacturing
August 02, 2017
Features
41
8
Statistical methods and novel indices can be used to monitor and benchmark variability, and guide continuous improvement programs in late-stage drug development.
EMA Increases Support for SMEs
August 02, 2017
41
8
EMA recognizes the need to provide more assistance and guidance to SMEs developing new medicines and applying for marketing authorizations.
Pharmaceutical Technology, August 2017 Issue (PDF)
August 02, 2017
Issue PDF
41
8
Click the title above to open the Pharmaceutical Technology August 2017 issue in an interactive PDF format.
Avoiding Investigational Failure/Discrepancy-Related Form 483 Observations
August 01, 2017
41
8
Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.