Manufacturing

The adequate absorption and transport of drugs in the body is part of optimal therapy. Drug administration perorally is easy, common and traditional, but occasionally alternative routes are required.

Inspecting punches and dies can be time-consuming and costly for tablet manufacturers. Advances in technology, however, have greatly improved in-process inspections. The author examines improvements in equipment and computer software for in-process tool inspections.

Process designs and control strategies can be improved by adopting a risk-based approach to product quality. The author describes how this approach can be applied to spray-drying operations.

When Pharmaceutical Technology Europe was established 20 years ago, PAT was not a hot topic in the industry. It was started in 2002 by FDA to modernize pharmaceutical manufacturing and increase the efficiency of manufacturing processes.

Practical guidance on how to handle validation failures cannot be found in the existing literature because they are not supposed to happen.

Traditional tablet presses do not measure tablets' tensile strength, yet this characteristic strongly influences tablet quality. The author describes a compression technique that accounts for tensile strength and produces tablets with consistent weight and disintegration time.

Congress is taking on the issue of inspection of foreign drug-manufacturing facilities as it began hearings on a discussion draft of the Food and Drug Administration Act of 2008.

Also, Genzyme to build R&D center in Beijing, Noven Pharmaceuticals appoints Peter C. Brandt president and CEO, more...

Problems associated with contamination of heparin products continue after worldwide recalls in March in the United States, Italy, France, and Denmark.

Researchers from the Georgia Institute of Technology described a fast method to detect counterfeit "Tamiflu," Roche's drug for preventing and treating bird flu.

The US House of Representatives Energy and Commerce Committee is proposing legislation to address the funding and authority of the US Food and Drug Administration in regulating the safety of the country's drug supply.

Ell Lilly plans to streamline a portion of its manufacturing operations in Indianapolis.

Also, GSK expands in Ireland, executive appointments at ProGenTech, more...

The US Food and Drug Administration issued a final guidance last week regarding investigational new drug applications for human gene therapy.

A manufacturing line can be improved if technology transfer is implemented thoughtfully. Effective technology transfer helps to provide process efficiency and control and maintain product quality.

MannKind suspended discussions with potential partners for the commercialization of its "Technosphere Insulin" product.

This issue of Equipment & Processing Report features products from Leistritz and Millrock Technology

Dave Drew, group pharmaceutical director of Matcon (Moreton-in-Marsh, UK), says that lean production is essential for drugmakers to survive in the current environment.

Takeda Pharmaceutical agreed to acquire Millennium Pharmaceuticals for $8.8 billion in cash or $25 per share.

Also, Alcon plans to open Singapore facility, Pharmacopeia president and CEO retired, more...

Also, Jubilant Organosys to acquire DRAXIS Health, PPD's Paul Covington to retire, more...

Schering-Plough announced a major new productivity transformation program with a goal of achieving $1.5 billion in annual savings.

The US Food and Drug Administration withdrew a direct final rule that changed current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. The agency withdrew the rule because it received significant adverse comments from industry.

The deadline for the implementation of California's prescription drug tracking system, ePedigree, has been delayed until January 2011.

At its annual meeting, the Pharmaceutical Research and Manufacturers of America elected Richard T. Clark, CEO and president of Merck & Co., chairman of its board.

One more step closer to finalization, the ISA 100 Wireless Compliance Institute presented a live demonstration of a prototype of the ISA 1001.11a wireless standard-based products at the 2008 Wireless Conference in Chongquing, China.

Also, VaxGen and Raven terminate merger agreement, Darren Head appointed CEO of Cytovance, more...

Filing risk and mitigation strategies is now a requirement for manufacturers of new drugs and biologics.

A reference book omits important information and ignores advanced testing procedures.

Essential components of a good inspection: good ingredients, proper inserts, and ... deer?