Manufacturing

Market demand for cytotoxic drugs is leading CMOs to expand their API manufacturing and formulation services.

The US Food and Drug Administration launched a new program on Oct. 4 to increase the number and variety of generic drugs available to the public, beginning in fiscal year 2008. The Generic Initiative for Value and Efficiency (GIVE) will use existing resources to help the agency "modernize and streamline the generic drug approval process," according to FDA.

Candid comments from a Big Pharma executive highlight the complexity of contract manufacturing.

In this study, fault tree analysis applied to a water pretreatment and purification installation exposed cause-and-effect complex interrelations in possible fault events.

Natural gums and mucilage have been widely explored as pharmaceutical excipients. The goal of this study was to extract mucilage from the leaves of Aloe barbadensis Miller and to study its functionality as an excipient in pharmaceutical sustained-release tablet formulations.

News and Views

Thin are the lines that separate stability, statistics, and chaos.

A book illustrates the potential for nanoparticulate drug delivery, and how much about them remains to be understood.

New FDA act reshapes drug development and marketing to restore public trust in pharmaceutical regulation.

Mixed-flow impeller systems exhaust laboratory workstation fume hoods, prevent reentrainment into the facility and adjacent facilities, and help companies comply with appropriate pollution-control standards.

With appropriate standardization from an interfacing point of view, separation science will find a broader audience in PAT.

Maintenance and service-related items are often the second-largest budget element in a laboratory after salaries and benefits. Within maintenance, preventive maintenance (PM) is a substantial portion of the budget. Traditionally, PM was an equipment maintenance philosophy based on replacing, overhauling or remanufacturing a piece of equipment at fixed intervals, regardless of its condition at the time. In essence, it involved fixing something that wasn't necessarily broken and this approach is still widely used in the pharmaceutical industry.

Pharmaceutical manufacturers are under increasing pressure to shorten time-to-market, produce treatments with unpredictable product lifetimes, provide greater flexibility and, at the same time, comply with ever more stringent quality, validation, stability and traceability constraints. While this is encouraging for the contract manufacturing sector, it creates the need for even greater manufacturing flexibility.

Vaccines are needed against old and new infectious disease threats - polio and other childhood illnesses, bioterrorism and pandemic flu. They are also emerging for cancer immunotherapy and for treating addiction. While vaccines are among some of the most successful biotech products, their large-scale manufacture involves some special demands, such as maintaining a good working cell bank and gearing up for production on an 'as needed' basis.

The crystalline structure of pharmaceutical solids can sometimes be altered during processing. X-ray powder diffraction and near infrared spectroscopy can be used to determine the amorphous and crystalline content of a model substance. The two techniques' precision, accuracy, detection limit and the speed of analysis are compared.

Novartis opened a new $180-million tableting facility in late October in Singapore and announced its intention to construct a $700-million cell-culture facility in the country.

More than ever, drug makers need to be fleet and flexible-and they need their software to be the same.

Company Notes: Gibraltar expands facilities; Allozyne appoints new president and CEO, more.

The US Food and Drug Administration announced the formation of the Pediatric Review Committee to help ensure quality and consistency across the agency.

Seven Reasons Why Pharmaceutical Makers Are Adopting Mobile Technology

The pharmaceutical market is undergoing a major transformation with companies moving more and more toward the generics business, according to a new report.

After a whirlwind of negative press this fall regarding the safety of cough and cold medications for children under age 6, the US Food and Drug Administration?s Nonprescription Drugs and Pediatric Advisory Committees have recommended such over-the-counter drugs no longer be used for young children.

Company and People Notes: ImClone, BMS, and Merck form agreement; CRI Worldwide names new CEO, more.

Medical students are participating in various activities this week to persuade medical schools to shield their campuses from the influence of pharmaceutical marketing as part of ?National PharmFree Week.?

Under a new US Food and Drug Administration revision, sole manufacturers of drugs considered life-supporting, life-sustaining, or for prevention of certain serious diseases or conditions will be required to notify FDA at least six months before discontinuing production of the product.

On behalf of manufacturers of over-the-counter (OTC) infant cough and cold medications, the Consumer Healthcare Products Association announced a voluntary withdrawal of products intended for use in children under age 2.

The US Food and Drug Administration sent Med-South Pharmacy a Warning Letter for producing large volumes of betamethasone acetate?betamethasone sodium phosphate without following current good manufacturing practices (CGMPs).

Company and People Notes: Orexo acquires Biolipox, Avalon cofounder resigns, more...

The collaboration of two companies will mean the process-scale implementation of an innovative technique for creating complex proteins from moss cells.