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Pharmaceutical Technology-06-02-2019
Pharmaceutical Technology
Hovione Technology Develops Blister-Based Inhaler
June 02, 2019
Features
43
6
A simple, one-part DPI aims to make inhalation drug treatment more accessible and affordable.
Enabling Technologies Advance Poorly Soluble Highly Potent APIs
June 02, 2019
API Synthesis and Manufacturing
43
6
Excipients and new processing techniques can make a real difference in the development of highly potent therapies.
Pharma Facilities Still Have a Lot to Learn
June 02, 2019
From the Editor
43
6
FDA’s annual manufacturing report card shows more quality compliance is needed.
Filling the Early Intermediate Security Gap
June 02, 2019
Features
43
6
With an increased focus on the supply chain security of non-cGMP intermediates, companies need to re-emphasize upstream manufacturing.
As Easy as ABC?
June 02, 2019
From the Editor
43
6
Big Pharma is partnering with Alphabet company, Verily, to modernize clinical trials and accelerate time-to-market for drugs.
Regulating Cannabis-Based Medicines in Europe
June 02, 2019
Regulatory Watch
43
6
The current fragmented regulatory approach to cannabis medicines across Europe is challenging to harmonize.
Supply Chain Risk and Security Maturity Evolution
June 02, 2019
Features
43
6
Discussing supply chain risk and security as a business led journey, Roddy Martin, chief digital strategist at TraceLink, explains the five stages of its evolution.
On the Right Track
June 02, 2019
Features
43
6
Proactive approaches that consider long-term supply chain security compliance are recommended to ensure companies stay on the right track.
Looking Beyond the Solubility Horizon
June 02, 2019
Features
43
6
Exploration of various formulation techniques is vital to provide effective delivery of poorly soluble drugs.
Enhancing Bioavailability with Hot-Melt Extrusion
June 02, 2019
Features
43
6
Discussing the advantages, limitations, and recent advances of HME with experts from AbbVie.
Leveraging Computational Models of Glycosylation for Biopharma QA
June 02, 2019
Features
43
6
Close collaboration between academic and industrial groups is vital to ensuring glycosylation models are fit for deployment.
FDA Advances New Approach to Drug Quality Assessment
June 02, 2019
Regulatory Watch
43
6
CDER’s KASA program seeks manufacturer data on drug attributes and risks to inform oversight.
Considering Connected Inhalation Drug Delivery
June 02, 2019
Features
43
6
A connected MDI may encourage compliance and aid proper technique.
Quality Agreements and Out-of-Specification Investigations
June 02, 2019
Ask the Expert
43
6
A good working relationship between sponsor and contractor will become invaluable when an OOS occurs, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
Putting Drug Delivery into Patients’ Hands
June 02, 2019
Cover Story
43
6
Wearable and smart devices allow user-friendly subcutaneous drug delivery.
Pharmaceutical Technology North America, June 2019 (PDF)
June 02, 2019
Issue PDF
43
6
Click the title above to open the Pharmaceutical Technology June 2019 issue in an interactive PDF format.
Good Laboratory Practices: Getting on the Same Page
June 02, 2019
Features
43
6
Quality and compliance depend on the right approaches to training, standard operating procedures, and validation. More tools are available to help ensure success.
Batch or Continuous? Ask the Right Questions During Scale Up
June 02, 2019
Features
43
6
Continuous manufacturing may offer huge opportunities, but it will not be right for every facility or product.
Defining and Managing Raw Manufacturing Data
June 02, 2019
Peer-Reviewed Research
43
6
Protecting the integrity of raw data is crucial to regulatory compliance and to proving that manufacturing and quality operations are being run and managed properly.
Sanitary Tumble Blenders
June 02, 2019
Product Spotlight
43
6
The Ross VCB-0.25 Tumble Blender is suited for specialty blends with extremely minor active components and additives.
Microbioreactor System
June 02, 2019
Product Spotlight
43
6
Sartorius Stedim Biotech’s Generation 2 ambr 15 cell culture microbioreactor system offers increased flexibility and expanded capability for clone selection, media and feed optimization, and early process development work.
Cleanroom Monitoring Software Solution
June 02, 2019
Product Spotlight
43
6
Particle Measuring Systems’ new Pharmaceutical Net Pro cleanroom monitoring software for data and collection management and automation offers flexible integration options and intelligent features such as facility mapping, alarming, reporting, and recipe-driven sampling.
Hygienic Diaphragm Valve
June 02, 2019
Product Spotlight
43
6
The EnviZion hygienic diaphragm valve from ITT Engineered Valves allows for simplified installation and maintenance.