Manufacturing

New maintenance models focused on efficiency improvements can deliver cost savings and enhanced service quality.

The first part of this article introduced the basic features of Raman spectroscopy and presented some examples of its application in the pharmaceutical industry. This second part focusses on the technique's application as a PAT tool within the pharmaceutical manufacturing environment. FDA's PAT initiative has provided motivation to explore the application of 'new' analytical technologies to the pharmaceutical manufacturing process and Raman spectroscopy shows great promise. The strengths and weaknesses of the technique as a potential PAT tool are discussed together with some examples of how this works in practice in a pharmaceutical manufacturing environment.

Measuring, understanding and ultimately controlling manufacturing processes offers pharmaceutical companies a route to greatly enhance the business effectiveness of both their product development process and facilities. PAT creates technological, business process and regulatory frameworks to enable this. This paper looks at a PAT overview within the context of developing and manufacturing a tablet product, highlighting the potential of FT-NIR spectroscopy.

Various systems and measures can be used to safely handle and process explosive pharmaceutical compounds in a range of manufacturing procedures.

Process analysers have evolved from basic analogue devices with adjustable potentiometers, analogue current outputs and alarm relays into smart, powerful, two-way digital transmitters with advanced features, such as automatic calibration and self-diagnostics, that can transmit more information, more accurately. This article will discuss advances in process analytical devices and how they can be applied to both new and existing pharmaceutical facilities.

Microbioreactor Array System Boost Cell Culture Capacity

Teva Absorbs Ivax In $7.4 Billion Bid

Protein Refolding Technology Improves Yields

Aptuit To Purchase Quintiles

Able Labs Files for Chapter 11

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Xanodyne Acquires aaiPharma Assets

Chiron Cuts Supply of Flu Vaccines Made in Germany; Liverpool Plant Under Inspection

Able Interim Chief Resigns Amid Drug Recall

First Contraceptive Spray Offers Advantages over the Pill

Q Chip Develops Fully Functioning MicroPlant

A stepwise, process risk-assessment approach can facilitate the identification and understanding of critical process parameters, quality attributes, and in-process controls. This approach can lead to more use of science- and risk-based regulatory practices to simplify the regulatory requirements for changes to synthetic processes and to support the underlying quality systems that ensure compliance.

Singapore is competing aggressively with India and China for a piece of the Asian sourcing business.

Can macromolecular processes learn from small-molecule experience? Burdened by exploding bioreactor productivity, architects of downstream bioseparation technology are looking into the drug industry's past for inspiration, while small-molecule companies adopt techniques pioneered by biotechnology. (The first of three articles on the current state of separations.)

Genentech Anticipates Full-Capacity Manufacturing

Schering AG To Cut Plants and Staff

Molding Technique Improves Nanoparticle Production

Warning Letter: Pragmatic Materials

FDA Posts Q5E Biotech and Biological Products Comparability Guideline

Blister Packaging Trumps Bottles For Patient Compliance, Study Shows

Wyeth and Purdue Announce Restructuring Plans

Development Collaboration for Ophthalmic Drugs Could Eliminate Injections

Warning letter: C&M Oxyfill

Self-Assembly Nanotechnology Improves Microencapsulation