Manufacturing

Sometimes doing what you think is right ends up being completely and utterly wrong.

Covance's deal with sanofi-aventis demonstrates the power of scale and scope.

The author explains the idea of equivalence and describes how it can facilitate equipment validation.

The authors evaluated the effect of alcoholic beverages on the release profiles of sustained-release dosage forms containing metformin and diclofenac.

GlaxoSmithKline (GKS, London) outlined a plan to invest EUR 500 million ($649 million) in research and development (R&D) and related manufacturing in the United Kingdom conditioned on the successful implementation of a so-called "patent box" measure by the UK government.

The growing uptake of single-use sterile packaging in pharmaceutical production processes mirrors the broader trend towards single-use across every sector of the pharmaceutical industry.

One of the biggest challenges in designing cleanroom doors for the pharmaceutical industry is in creating a sturdy door with a high hygienic performance that is light and easy to clean.

Modular cleanrooms are a flexible and adaptable solution that come on the back of a lorry and offer numerous benefits.

When it comes to monitoring the cleanroom, too much emphasis is often directed at the annual check, but ongoing monitoring is also crucial.

Contract Manufacturing Organisations offering manufacturing capabilities to suit specific industry sectors, niche segments or perhaps simply to meet the demands of individual clients? processes face a greater challenge when designing their facilities and cleanrooms when compared with an originator company or a single-product manufacturing facility.

With the increasing need for businesses to reduce costs and demonstrate value, there is a requirement to look at all aspects of bio/pharma drug development and manufacturing to achieve efficiency improvements.

Contamination in all its forms should be identified and reduced whenever and wherever possible.

A case study describes how a software control system can manage training needs across an international company and improve GMP compliance.

On Nov. 17, 2010, Novartis (Basel) disclosed its long-term business strategy, which emphasizes diversification in what the company described as high-growth healthcare segments.

Genzyme Sells Business Unit to Sekisui Chemical; Ablexis Names VP of Research; and More.

Bayer (Leverkusen, Germany) announced last week a restructuring program and a strategy to strengthen its focus in research, development, and marketing of new products in its healthcare and crop-sciences businesses as well an interest in expanding its activities in emerging markets.

European confidence and optimism in biotechnology is increasing, according to a survey conducted by the European Commission.

During the 20 months before the crisis of contaminated heparin in early 2008, the US Food and Drug Administration did not inspect any Chinese heparin firms, according to a US Government Accountability Office, (GAO) report.

Roche Details Restructuring Plan; Sigma-Aldrich Names Successors after CEO's Death; and More.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the November 2010 edition from BinMaster and Silverson Machines.

To find out about the regulatory, formulation, and manufacturing considerations involved in developing a new device to deliver a drug, Equipment and Processing Report talked to Paul Wotton, CEO of Antares Pharma.

Normal industrial practice is to control foot-borne contamination with adhesive peel-off disposable mats, but polymeric contamination-control flooring is becoming increasingly popular.

The biotechnology company Biogen Idec (Weston, MA) announced last week a major restructuring program that will refocus the company's research and development (R&D) programs, consolidate facilities, and reduce its workforce.

The US Food and Drug Administration's Puerto Rico district office "may be having difficulty exercising oversight on the numerous pharmaceutical manufacturing facilities on the island," according to Rep. Edolphus Towns (D-NY), chair of the US House of Representatives Committee on Oversight and Government Reform.

Eli Lilly Acquires Avid Radiopharmaceuticals; EMA Recruiting New Director; and More