Pharmaceutical Technology-11-02-2018

Regulatory Watch
Pharmaceutical Technology

November 12, 2018

Pharma companies are concerned they may have to postpone plans for the commercialization of new combination products because of delays in obtaining marketing authorizations because of a lack of clarity about approval rules.

A matrix of multi-functional cleanrooms can be adapted for launching products.

Mechanistic process and product modeling turns data into knowledge that can be extrapolated with known confidence for design space characterization and risk assessment.

Pharmaceutical Technology
Product Spotlight

November 02, 2018

Wilden, part of PSG, a Dover company, released its new 6 mm (1/4”) Velocity Series air-operated double-diaphragm (AODD) pump.

Pharmaceutical Technology
Product Spotlight

November 02, 2018

Ross, Charles & Son’s Laboratory Paddle Blender offers advanced features for automated powder blending and liquid spraying operation with recipe management.

Pharmaceutical Technology
Product Spotlight

November 02, 2018

Ross, Charles & Son added a custom 150-gallon Triple Shaft Mixer, the Ross VersaMix Model VMC-150, with elaborate automation and safety functions.

Pharmaceutical Technology
Product Spotlight

November 02, 2018

Stream Bio’s Conjugated Polymer Nanoparticle products are a new generation of novel molecular bioimaging probes for diagnostic and therapeutic applications.

Ask the Expert
Pharmaceutical Technology

November 02, 2018

Building up relevant expertise in-house will make writing spec sheets for software easier, according to Siegfried Schmitt, principal consultant at PAREXEL.

Pharmaceutical Technology

The growth in adoption of single-use systems for commercial manufacturing will be dramatic in coming years.

Pharmaceutical Technology

As biologic drugs grow increasingly complex, drug delivery mechanisms such as prefilled syringes are being adapted to meet the challenges.

Pharmaceutical Technology

This article will explore the requirements for media and supplements needed to maintain newer cell lines, such as those based on human cells and fungal cells.

Pharmaceutical Technology
Peer-Reviewed Research

November 02, 2018

This paper describes how the concept of acceptance value can be redefined to remove bias and more closely reflect quality targets.

Pharmaceutical Technology
API Synthesis and Manufacturing

November 02, 2018

Demand for highly potent APIs continues to rise.

From The Editor
Pharmaceutical Technology

November 02, 2018

Survey results and record attendance show positive signs for various bio/pharma regions.

Pharmaceutical Technology

Experts share best practices, and war stories, for a crucial but often underappreciated part of drug development.

Pharmaceutical Technology
Features

November 02, 2018

New FDA guidance offers a time buffer but increases supply-chain-management complexity, as active DSCSA enforcement begins.

Issue PDF
Pharmaceutical Technology

November 02, 2018

Click the title above to open the Pharmaceutical Technology November 2018 issue in an interactive PDF format.

From The Editor
Pharmaceutical Technology

November 01, 2018

… Brexit may be a bumpy ride. Here, the new European editor of the PharmTech Group, Felicity Thomas, discusses Brexit and its implications for the pharma industry.

Regulatory Watch
Pharmaceutical Technology

October 19, 2018

To achieve a more dynamic marketplace, FDA is issuingguidance documents and targeted advisories to support R&D on complex generics and combination products.