Manufacturing

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

The market for orally disintegrating and fast dissolving tablets could exceed revenues of $13 billion by 2015 based on upward global growth trends, according to a report from Technology Catalysts International, a technology transfer and business consulting firm based in Virginia.

Sanofi-aventis (Paris) has asked Genzyme to stand aside and let the shareholders decide on whether an acquisition should take place.

The growth in pharmaceutical outsourcing is creating a more complex and risky supply-chain environment, according to a report issued last week.

sanofi acquires BMP Sunstone; DCAT Names President; and More.

Pfizer (New York) announced on Oct. 29, 2010 that it intends to recall two additional lots--approximately 38,000 bottles--of Lipitor (atorvastatin calcium) 40 mg tablets distributed in the United States.

From fiscal year 2007 to 2009, the US Food and Drug Administration increased the number of foreign drug inspections it conducted, but the agency still conducted fewer foreign inspections than domestic inspections each year, according to a recent report by the US Government Accountability Office (GAO).

Editors' picks of pharmaceutical science and technology innovations.

Abuse-deterrent combination drugs represent a niche area in formulation development.

USP is working to ensure quality standards and to increase public information.

A recent book offers an excellent overview of cleaning validation.

IP rights and levels of innovation have opened a bit of controversy regarding decisions being made by Indian courts and legislators.

An analysis of the approaches and tools used to tackle the problem of poorly soluble drugs.

A conversation with Mike de la Montaigne, president of Eisai Machinery, USA Inc., about the possibilities for conducting fully automated product inspections.

As technology advances, industry's needs are growing.

Scientists and practitioners must work together for the overall good of the patient.

A new center may provide evidence for improving care, but could discourage coverage of treatments.

The authors describe the development of an inclusion complex of GLZ and formulated an extended-release dosage form based on osmotic technology.

Remaining calm, cool, and collected during mergers and inspections is a feat in itself.

The authors demonstrated that ODTs can be obtained by direct compression of a mixture of starch, fructose, and SMCC.

Post recession and beyond, which contract service providers will still be standing?

Connecting science and policy might increase support for innovation.

Used packaging equipment can be a cost-saving, time-saving alternative to new machines.

Stuart Needleman, president of active-ingredient development and manufacturing at Aptuit, discusses industry trends and challenges.

The author reviews key considerations for formulating powders for use in inhalers. This article is part of a special Drug Delivery issue.

Product integrity issues in the global pharma market are a hot topic at the moment and many companies are reviewing and increasing their quality control procedures.