Manufacturing

Some GMP agents seem to find a way to squander time, money, and common sense.

Is it good policy to pay for bad behavior?

High-potency manufacturing of active pharmaceutical ingredients is a growing and specialized capability.

Brief pharmaceutical news items for July 2009.

A look at the true cost-drivers of cell-culture production.

Developers of low-dose drugs in solid oral dosage forms will find theoretical considerations and practical advice in a new book.

The authors discuss the theory of ion mobility spectrometry, its benefit over HPLC analysis in cleaning verification, and the experimental considerations for method validation and validation.

The authors describe a proprietary process for producing a stable, topical interferon alpha-2b formulation that can deliver large drug molecules into the skin or mucosa.

Large-scale manufacturing of human stem cells for therapeutic use is a leap in technology and science for the current biotechnology industry.

The authors discuss how strategic outsourcing to contract manufacturing organizations that have technical and regulatory expertise can add further value during vaccine development.

During the past decade, big pharmaceutical companies have been making major efforts to restructure their manufacturing networks. In their haste to shed costs and assets, however, some may be adding risk to their product supply chains.

Are manufacturers ready to deal with the economic and logistical challenges that accompany tailored therapeutics?

A number of commentators during the past few years have speculated that nanotechnology is the wave of the future in biotech and pharma.

Tablets, PTK Tablet Presses, Surepharm Services

Successful Cooperation Yields Anti-Stick Rewards

Also, Adimab forms deals with Merck and Roche; Manhattan Pharmaceuticals' CEO and president steps down; more...

Generic-drug and specialty pharmaceutical manufacturer Watson Pharmaceuticals (Corona, CA) agreed to acquire the generic-drug company Arrow Group for $1.75 billion in cash and stock.

Also, FDA debars clinical investigators; Jubilant Organosys forms deal with Endo Pharmaceuticals; AMRI makes changes to its India management team; more...

Following the World Health Organization's declaration last week of an influenza pandemic, vaccine makers in Europe and China as well as world health agencies are stepping up efforts toward rapid development and approval of an effective vaccine.

PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the May 2009 edition from Bullard and Teledyne Tekmar.

The emergence of influenza A (H1N1) and the efforts to provide vaccines to the vulnerable are timely examples of biopharmaceuticals' continuing importance.

To address the increasing popularity of drug-injector systems, the US Food and Drug Administration last week released a Draft Guidance for Industry titled, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products.

Also, TorreyPines Therapeutics to liquidate assets and dissolve company; EU's competition services to examine Pfizer/Wyeth merger; Akorn appoints Raj Rai interim CEO; more...

Kemwell (Bangalore, Karnataka, India) plans to build a new biopharmaceutical manufacturing plant in Bangalore, India, in a strategic collaboration with Boehringer Ingelheim (BI, Ingelheim, Germany), according to a Kemwell press release.

Patent infringement claims and a lack of clear global trade distribution routes may be unraveling the country's generic-drug export industry.

The US Government Accountability Office recommended that the US Food and Drug Administration draft a plan, including milestones, for developing its Sentinel system and ensuring the privacy and security of patients' healthcare data.

To address the increasing popularity of drug-injector systems, the US Food and Drug Administration last week released a Draft Guidance for Industry titled, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products.

The chief operating officer (COO) of Mylan (Canonsburg, PA), one of the world's leading generic drug manufacturers, has condemned the launch of authorized generic drugs during 180-day exclusivity periods.

The European Commission's (EC) Directorate-General for Enterprise and Industry (EC-DG Enterprise) announced last week that it will not continue preparing a commission directive on good manufacturing practices (GMPs) for certain excipients.

The US biotechnology industry reached aggregate profitability for the first time ever in 2008, representing the only bright spot in an otherwise dismal year for biotechnology financing and performance.