Pharmaceutical Technology Editors

Growing interest in continuous drug manufacturing has brought greater attention to in-line blending, a process that the petroleum and fine-chemicals industries have used for decades.

We are making an emulsion using a high-shear in-line mixer. It?s a 60-gal batch, and it?s taking nearly an hour to get the results we?re looking for. We have tried changing the in-line mixer?s workheads to a two-stage configuration, but it doesn?t affect the mixing time. Where are we going wrong?

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the February 2011 edition from Emerson Process Management and Spirax Sarco.

WuXi and BMS Form Collaboration; F. Michael Ball Leaves Allergan for Hospira; and More.

FDA Posts PDUFA Meeting Minutes

At a conference on preserving national security at the University of Pittsburgh Medical Center last week, FDA Commissioner Margaret Hamburg stressed the importance of medical countermeasures for responding to natural and deliberate threats to public health.

The EMA has issued a statement addressing the withdrawal of the marketing authorization for Thelin, which was voluntarily withdrawn in 2010 because of a risk of serious liver injury.

The European Organization for Rare Diseases (EURORDIS), an alliance of patient organizations and individuals, celebrated its fourth Rare Disease Day on February 28.

FDA and Georgetown University Form Innovation Partnership

Pfizer Completes King Acquisition; ViiV Healthcare Names Chairman; and More.

FDA recently sent sanofi-aventis two Warning Letters for its facilities in Frankfurt am Main, Germany, and Bridgewater, NJ.

FDA's efforts to improve access to treatments for rare diseases.

A roundup of developments in corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

This article is Part I of a three-part series on biopharmaceutical issues in public health, government, and developing-world markets. Part 1 focuses on drug-development. Part II, which examines manufacturing, appeared in the April 2011 of Sourcing and Management. Part III, which analyzes distribution and administration,appeared in the May 2011 issue.

Gilead to Acquire Calistoga; Bayer Healthcare Appoints Former Pfizer Exec; and More.

HHS Releases a New National Vaccine Plan

Last Wednesday, sanofi aventis agreed to acquire Genzyme for $74 per share in cash, or approximately $20.1 billion.

EMA Outlines Activities for 2011, and more.

Company and People Notes: sanofi to Acquire Genzyme; Lilly Makes Senior Appointments; and More.

US Senators Amy Klobuchar (D-MN) and Bob Casey (D-PA) introduced the "Preserving Access to Life-Saving Medications Act," which is intended to help address and prevent shortages of prescription drug medications.

A major pharmaceutical micronizing company consulted Telstar when it needed a mobile, high-containment isolation system suitable for housing 4-, 8-, 12-, or 15-in. micronizing jet-mill systems during the loading, milling, and offloading processes.

My drug failed a light-obscuration test, but after I filtered the drug for microscopic particle counting, I couldn?t see any significant particulate on the filter. What might have caused the failure, and why is it not visible?

Developments during the past several years have led many industry professionals to question whether nonsterile dosage forms are being produced in a state of control.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the February 2011 edition from Alfa Laval and GE Healthcare.

Pfizer Acquires Ferrosan's Consumer Health Business; Patheon Appoints Former Biogen Exec as CEO; and More.

On Feb. 4, 2011, the European Medicines Agency released new document on drug products that are manufactured using stem cells.

The Society of Chemical Manufacturers and Affiliates (SOCMA), in a statement submitted to the US Senate Subcommittee on Superfund, Toxic and Environmental Health, provided support for a bipartisan review of the Toxic Substances Control Act (TSCA) as that subcommittee considers reforming the  chemical control law.

Last Thursday, the US Senate scheduled the Patent Reform Act of 2011 for debate after the Senate Judiciary Committee passed the bill.

FDA Holds Workshop on Orphan Drugs

Last Friday, Senators Herb Kohl (D-WI) and Chuck Grassley (R-IA) reintroduced their "Preserve Access to Affordable Generics Act," which would presume that pay-for-delay settlements were illegal and give the Federal Trade Commission (FTC) the power to block them.