Dosage Forms

A spate of drugs are scheduled to come off patent, offering vast potential and competition.

This article presents a study of an aseptic environmental monitoring system for surface contamination at critical areas using a robot.

Merck & Co. acquires NovaCardia, Sanofi Pasteur completes vaccine-manufacturing facility, more

Novartis Vaccines plans to produce approximately 40 million doses of its ?Fluvirin? vaccine for distribution in the United States during the 2007?2008 flu season.

A new guidance issued by the US Food and Drug Administration earlier this month advises companies on how to treat polymorphic drug compounds?those that exhibit multiple structural forms?in filing abbreviated new drug applications.

Novartis Vaccines and Diagnostics, a division of Novartis AG (Basel, Switzerland) and IntercellAG (Vienna, Austria), a biotechnology company, will collaborate toward developing a broad range of vaccines.

... the biotech industry could make characterization of its products easier by paying more attention to downstream processing and purification issues, creating a cleaner product that is easier to identify.

Washington, DC (June 14)-The US Department of Health and Human Services awarded two contracts totaling $132.5 million to Sanofi Pasteur and MedImmune to retrofit their influenza vaccine manufacturing facilities.

Basel, Switzerland (June 6)-Roche, in an agreement with the European Medicines Agency and the Swiss Agency for Therapeutic Products, recalled all batches of "Viracept" (nelfinavir) powder and tablets in Europe and some other regions of the world.

Rockville, MD (May 31)-The US Food and Drug Administration issued a draft guidance on how to design bioequivalence (BE) studies for specific drug products to support abbreviated new drug applications (ANDAs).

Rockville, MD (May 31)-The US Food and Drug Administration finalized guidances for seasonal and pandemic influenza vaccines, outlining the regulatory pathways for developing and approving these products.

Pharma companies and CMOs build positions in mAbs.

Nanotechnology is emerging as a tool for resolving challenges in delivering poorly water soluble and highly potent drugs.

Exhibitors' products prevent counterfeiting, provide child resistance, protect product quality, and improve packaging-line efficiency.

Sterile liquids are frequently transferred during the processing of sterile liquid drugs such as injectables or ophthalmic drops. Several types of transfer can be performed, each requiring a validated method to ensure the desired sterility-assurance levels are achieved.

It has been a long time coming, but stakeholders in the US are now seriously debating a route to market for cheaper copies of biopharmaceutical drugs. The European Agency for the Evaluation of Medicinal Products (EMEA) has led the way on this issue by publishing clear guidelines on what companies must do to get their versions of drugs such as erythropoietin (EPO), an advanced treatment for anæmia, and similar products approved.

Predicting the flow characteristics of powders during manufacture is especially important for the pharmaceutical engineer. Getting the powder flow wrong can be highly disruptive to plant performance and productivity, particularly where equipment has to be taken off-line and stripped down for cleaning out blockages. The flow behaviour of the individual ingredients may be well known, but as these are blended and reacted their flow properties can change.

Cells function as highly accurate quality control (QC) machines to ensure that only correctly folded proteins are released into the physiological milieu to perform their designated functions. The efficient removal of damaged or incorrectly folded/misfolded proteins at the correct time keeps a cell viable and functioning.

Acambis, FDA, Biogen, Ranbaxy, more

Darmstadt, Germany (May 13)-Mylan Laboratories Inc. and Merck KGaA have signed a share purchase agreement under which Mylan will acquire all of Merck's worldwide operations within Merck Generics, the company?s generics business.

Rockville, MD (May 1)-The US Food and Drug Administration issued a report, "Critical Path Opportunities for Generic Drugs," to identify the scientific challenges, including those in manufacturing science, in developing generic drugs and the opportunities for collaborative solutions in resolving those challenges.

Washington, DC (April 30)-Less than two weeks after the Senate Health, Education, Labor, and Pensions Committee voted to reauthorize the Prescription Drug User Fee Act (PDUFA), the bill this week moved onto the Senate floor.

Geneva, Switzerland (Apr. 27)-A meeting of the World Health Organization and the Committee for Medicinal Products for Human Use's approval of Novartis's new cell culture-derived influenza vaccine offered new hope that sufficient numbers of vaccines could be produced in case of a pandemic.

USP applies metrological principles to the dissolution procedure alone and in collaborative studies to understand and minimize potential sources of variability.

There is a tremendous need to enhance delivery of potential therapeutics to the brain for treatment of central nervous system (CNS) disorders. The blood brain barrier (BBB) restricts and controls the exchange of compounds between the CNS and the blood, which requires discovery of new modalities allowing for effective drug delivery to the CNS. Polymer nanotechnology has now become one of the most attractive areas of pharmaceutical research. This review focuses on the current progress in polymeric nanoparticles, where the specific arrangement of the polymeric matter at the nanoscale is utilized to design drug delivery systems that provide safe and efficient transport of CNS drugs across the BBB.

This article discusses a number of factors that may influence the behaviour of conjugated biopharmaceuticals. Optimizing bioconjugation processes may be critical to achieve the desired drug performance.

One of the major concerns with introducing PAT, however, is that the bias towards process engineering may not ultimately lead to complete control of product quality.

...Scotland has a favourable regulatory environment, funding support from its government and some of the most advanced research facilities in the world.

Irradiation is an established method of sterilization for pharmaceutical products. Radiation sterilization can be achieved with gamma rays, electron beams, and X-rays. Each of these techniques has its advantages and disadvantages. The author describes these methods, the ways to find the correct sterilization doses, and the regulatory and safety concerns about irradation sterilization.

Aseptic processing has advanced over the past several decades, yet the pharmaceutical industry is still accepting of its limitations, particularly as it relates to human intervention as a source of contamination. The authors explain the importance of further diminishing the role of operators in aseptic processing and the approaches and technologies needed to achieve that goal.