Pharmaceutical Technology-06-02-2019

A simple, one-part DPI aims to make inhalation drug treatment more accessible and affordable.

Excipients and new processing techniques can make a real difference in the development of highly potent therapies.

FDA’s annual manufacturing report card shows more quality compliance is needed.

With an increased focus on the supply chain security of non-cGMP intermediates, companies need to re-emphasize upstream manufacturing.

Big Pharma is partnering with Alphabet company, Verily, to modernize clinical trials and accelerate time-to-market for drugs.

The current fragmented regulatory approach to cannabis medicines across Europe is challenging to harmonize.

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.

Proactive approaches that consider long-term supply chain security compliance are recommended to ensure companies stay on the right track.

Exploration of various formulation techniques is vital to provide effective delivery of poorly soluble drugs.

Discussing the advantages, limitations, and recent advances of HME with experts from AbbVie.

Close collaboration between academic and industrial groups is vital to ensuring glycosylation models are fit for deployment.

CDER’s KASA program seeks manufacturer data on drug attributes and risks to inform oversight.

A connected MDI may encourage compliance and aid proper technique.

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.

Wearable and smart devices allow user-friendly subcutaneous drug delivery.

Click the title above to open the Pharmaceutical Technology June 2019 issue in an interactive PDF format.

Quality and compliance depend on the right approaches to training, standard operating procedures, and validation. More tools are available to help ensure success.

Continuous manufacturing may offer huge opportunities, but it will not be right for every facility or product.

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.

The Ross VCB-0.25 Tumble Blender is suited for specialty blends with extremely minor active components and additives.

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.

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.

The EnviZion hygienic diaphragm valve from ITT Engineered Valves allows for simplified installation and maintenance.