Pharmaceutical Technology-03-02-2007

The pharmaceutical supply chain lengthens as generic drug manufacturers build production platforms offshore and CMOs position in India and China to meet demand for lower-cost production.

Just because the wheels are turning doesn't mean they're going forward.

The low-volume pharmaceutical industry must adapt Lean Manufacturing tools invented for high-volume, single product industries.

Security, the environment, aging populations, the bio-boom, and cost control are just a few of the drivers that will influence pharmaceutical packaging for the remainder of this decade.

The proposed rule would impose new record-keeping requirements on some 1200 manufacturing establishments.

The authors describe the methods by which precise analyses of stable-isotopic abundances can be used in security and forensic applications for pharmaceutical materials. These methods include product and process authentication of raw materials, pharmaceutical intermediates, drug substances, formulated drug products, and synthetic pathways. Collectively, these methods can be used to investigate and mitigate patent infringement. In the future, more complete examples will be presented containing full isotopic results and the application of the methods described in this article.

FDA's new safety program, Critical Path Initiative, and user-fee proposal seek to reinvigorate pharmaceutical R&D.

Before we can intelligently set the limits of process variation, we need to know what the clinical impact of that variation will be.

The Parenteral Drug Association recently held its first global conference on emerging manufacturing technologies. Among the presentations were those discussing the latest in disposable technologies, aseptic filling and closing, and barrier systems. Clearly, technology vendors have stepped up efforts to streamline processes and better handle complex drug products.

Filling machines often are installed in sterile rooms and separated by isolators to prevent contamination. These methods have certain drawbacks, including making interventions more difficult. Restricted-access barrier systems are an alternative that ensures sterility and facilitates interventions.

Many companies are coming up with innovative materials and manufacturing methods to feed the growing demand for prefilled syringes.

As big pharmaceutical companies restructure and reevaluate the way they do business, contract research and manufacturing organizations could reap greater financial rewards.

The book is written for drug-delivery scientists experienced in the dermatological or transdermal fields.