Manufacturing

The US Food and Drug Administration issued an alert to healthcare professionals of a change in heparin manufacturing that is expected to decrease the drug's potency.

GlaxoSmithKline (London), Novartis (Basel, Switzerland), sanofi Aventis (Paris), and Baxter International (Deerfield, IL) recently provided updates as to the development, manufacture, or shipment of pandemic (H1NI) vaccines.

The US Food and Drug Administration published its first draft guidance for industry about Risk Evaluation and Mitigation Strategies (REMS) on Sept. 30, 2009.

Company and People Notes: GSK forms joint venture with China-based Jiangsu Walvax Biotech; Sigma-Aldrich appoints VP and board member; more...

AAPS President offers hope and solutions for the industry's challenging future.

Pharmaceutical companies in India have had a hold on the biotechnology sector for many years, and they're not about to let the follow-on biologics market pass them by.

The countries of Central and Eastern Europe and the Commonwealth of Independent States are closing in on global pharmaceutical competition.

Strict enforcement, new rules, and organizational changes signal an activist tone.

Industry, equipment vendors, and regulators are busy refining the precision and reliability of dissolution testing.

BIO supports recent Congressional action toward a 12-year data exclusivity period for innovators.

The nation's healtcare system needs an overhaul, but it has to be done right.

Like life, the workplace also can have many surprises.

Editors' Picks of Pharmaceutical Science & Technology Innovations

New nanotechnology-based delivery systems offer promise in drug delivery, particularly for anticancer therapeutics.

Brief pharmaceutical news items for October 2009.

Representatives of one pilot program participant, Wyeth, outline the experiences and lessons learned for implementing a science- and risk-based approach to drug-development and manufacturing.

The author discusses control strategies via near infrared instrumentation for continuous mixing, granulation, drying, and extrusion with a more focused detail on mixing.

Almac's expansion plans in Northern Ireland (UK) could see the creation of more than 500 jobs during the next 5 years.

Contract research organizations such as Covance are heading further east through Europe.

A review of NIPTE's core projects and its plans for training-and retraining-the pharmaceutical industry.

This article introduces the "Q.U.E.S.T." approach for vendor qualification, a practical and compliant methodology for pharmaceutical and biopharmaceutical companies to qualify vendors and hence make well-informed purchasing-related decisions.

As the pharmaceutical industry moves further into Central and Eastern Europe and the Commonwealth of Independent States, several standard-setting and regulatory bodies are also increasing collaboration in the region, particularly in Russia.

The author describes the framework needed to implement QbD and achieve the deeper process understanding that is fundamental to QbD.

This article is part of a Special Report on the Emerging Markets of The East, October 2009

Pharmaceutical companies get ideas for sustainable packaging from other industries.

The author analyzes, from an agency perspective, whether question-based review has improved product quality or made the review process easier for regulators or for industry.

Jeff Robertson talks about a unique form of micro-tag technology that can be applied to solid dose pharmaceuticals.

Even though the pharmaceutical industry has come to recognize the importance and associated benefits of using computers, evolving computer-based simulation technology has still to make a suitable impression.

Endotoxin removal from a finished product is a major challenge for biopharmaceutical manufacturers; particularly as all endotoxin removal methods have operational limitations and may result in loss of protein.

A new report evaluating the biotechnology sector in new European Union member states and candidate countries has described biotech developments as "uneven" because of contrasting economic strategies in different countries.