Manufacturing

The European Generic medicines Association (EGA) has made a number of recommendations on how to ensure the quality of medicines in the globalized supply chain; in particular, the EGA spoke about API quality and quality supervision, and how these can be improved by transparent communication between authorities and industry.

GlaxoSmithKline (GSK) has provided further details concerning its new unit dedicated to rare diseases, which was launched in February.

Jeffrey Hartry, director of quality systems and information at Cangene (Winnipeg, Canada), talks about his company?s conversion from a paper-based to an electronic training-management system.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the October 2010 edition from EMD Millipore and Sartorius.

An expert-panel-written book has surprising shortcomings.

sanofi to Cut 25% of US Workforce; AMRI Names VP of Chemical Development; And More.

Following the low growth of the global pharmaceutical market in 2010, IMS Health's IMS Market Prognosis now expects the industry to rebound somewhat in 2011, growing at a rate of 5-7%, compared with only 4-5% in 2010, to reach $880 billion.

On Tuesday, Pfizer (New York) and King Pharmaceuticals (Bristol, TN), a specialty pharmaceutical-discovery and clinical-development company, entered into a definitive merger agreement under which Pfizer will acquire King for $3.6 billion in cash, or $14.25 per share.

On Monday, sanofi-aventis (Paris) began a hostile tender offer of $69 per share for all outstanding shares of Genzyme (Cambridge, MA).

The US Pharmacopeia released a statement this week that explains in more detail last January's recall of the United States Pharmacopeia 33–National Formulary 28 (USP 33–NF 28).

Company and People Notes: Novartis Settles with US Attorney's Office; Hospira Names VP, And More.

The reopened debate over embryonic-stem-cell research could stifle many other scientific pursuits.

Private companies and universities are developing new ways to deliver protein drugs.

Public-private R&D partnerships are on the rise across Europe, but national goals and academia-industry competition could prevent their success at the European level.

Global pharmaceutical companies could have a problem getting rid of redundant facilities.

Editors' picks of pharmaceutical science and technology innovations.

An expert-panel-written book has surprising shortcomings.

Drugmakers hatch new manufacturing paradigms in the wake of the 2009 H1N1 influenza pandemic.

From disagreement to denial, being cordial about quality control can be challenging.

Pfizer's acquisition of Wyeth involves augmenting its biopharmaceutical product portfolio, pipeline, and related development and manufacturing capabilities.

The president of Gibraltar Laboratories, Daniel Prince, discusses industry trends and challenges.

A look at MVI's malaria work in developing countries.

Novartis' Matthew Stober discusses vaccine manufacturing, including egg- and cell-based systems.

In light of compendial changes, representatives of the US Pharmacopeia and an industry consortium provide perspectives on cap and ferrule labels.

The authors developed a formulation for effervescent gastroretentive drug delivery techniques using ibuprofen as a model drug. They optimized the formulations by applying full factorial design.

President Obama and HHS eye innovation and countermeasures to protect public health.

There are a number of validation approaches that can be adopted for single-use systems - all of which incorporate an established approach.

Since its introduction more than 10 years ago, single-use bioreactor technology has now become an established addition to today's biotechnology manufacturing facility.

Single?use solutions, such as bags, tank replacements and aseptic connection devices (ACDs) have revolutionised our industry, providing improved sterility assurance.

There are apparent inconsistencies between the use of these reference materials and the manufacture of the reference solutions that are actually used in the regulated test method.