The evolution of therapeutic modalities drives the adoption of single-use technologies.
FDA Commissioner Testifies Before Congress on Foreign Inspection Process
November 8th 2007US Food and Drug Administration Commissioner Andrew C. von Eschenbach testified before Congress last week to outline the agency’s inspection process for foreign drug manufacturers and efforts to improve the agency’s information technology systems.
Congress Focuses on FDA Inspections of Foreign Drug Facilities
November 8th 2007The US Food and Drug Administration’s effectiveness in regulating the manufacture of pharmaceutical products and active pharmaceutical ingredients at foreign facilities was questioned at a Congressional hearing last week. Congress, industry, and government officials weighed in on the issue.
King and Acura to Develop Immediate-Release Pain Medicines
November 8th 2007King Pharmaceuticals, and Acura Pharmaceuticals have entered into a license, development and commercialization agreement for the United States, Canada, and Mexico, encompassing a potentially wide range of opioid analgesic products utilizing Acura?s patented Aversion (abuse-deterrent) Technology platform.
Preventive maintenance strategies for the pharmaceutical industry
November 1st 2007Maintenance 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.
Packaged solutions for flexible production
November 1st 2007Pharmaceutical 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.
Pandemics to polio — challenges in vaccine manufacture
November 1st 2007Vaccines 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.
Monitoring processing-induced crystallinity changes
November 1st 2007The 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.
FDA Committees Recommend Ban on Cough and Cold Medications for Young Children
October 24th 2007After 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.