Manufacturing

Manufacturing methods for new drugs could be made greener and more efficient with the help of marine microbes.

The US Food and Drug Administration?s Draft Guidance for Industry?Process Validation: General Principles and Practices provides a life-cycle approach for validating pharmaceutical processes and aims to help pharmaceutical companies achieve consistently high product quality.

PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the August 2009 edition from AEC and Sensor Products.

Cooling water is a critical component in the research and development, bulk manufacturing, and packaging of pharmaceuticals.

Also: DSM's North Carolina facility receives SafeBridge certification; Dynavax CFO to retire; more...

Baxter International (Deerfield, IL), sanofi aventis (Paris), and Novartis (Basel, Switzerland) provided updates last week of their production and regulatory activities relating to preparedness in supplying the A(H1N1) pandemic influenza vaccine. Novartis also outlined its activities for providing seasonal flu vaccines.

On August 6, the Biotechnology Industry Organization (BIO) filed an amicus brief asking the US Supreme Court to overturn Bilski v. Doll, a decision of the US Court of Appeals for the Federal Circuit.

The US Food and Drug Administration released its Guidance for Industry titled Pharmaceutical Components at Risk for Melamine Contamination.

Soelkner discusses the latest industry developments and trends.

Collaborative planning and execution among clinical research, clinical operations, and supply-chain managers are key elements in effectively managing an increasingly complex and global supply chain for clinical trial materials.

The US Food and Drug Administration announced its prescription drug user fee rates for fiscal year 2010 in the August 3 Federal Register.

Also, Pfizer forms two research agreements in China; NanoInk appoints John Kubricky to its scientific advisory board; more...

Editors' Picks of Pharmaceutical Science & Technology Innovations

Brief pharmaceutical news items for August 2009.

Biotech firms must first close the gaps between science and biology on the path toward QbD.

Big Pharma entered biotech too late. That same mistake can be avoided in personalized medicine.

An expanding number of products and services plug gaps in the cold chain. This article contains bonus online-exclusive material.

The author of an ambitious book about quality control falls short of reaching his goals.

The authors applied near-infrared (NIR) spectrophotometry to assess whether eight drug products were authentic or counterfeit.

The author of a book about biopharmaceutical production includes irrelevant information.

Individuals and companies at the top seem to have no problem short-circuiting their success.

Determined to prevent further supply-chain breaches, industry takes charge, offers proposals.

Pressure to reduce healthcare spending has put drug rebates, price cuts, and tax hikes on the table.

An ounce of contamination usually leads to a mountain of investigation.

In the aftermath of recent restructuring, Big Pharma is sporting a reduced global manufacturing footprint while intensifying its focus to biologics and emerging markets. What will be the look of tomorrow's manufacturing networks?