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Cell therapies are being developed for a rapidly expanding range of indications. Genzyme Corporation has a treatment of cartilage in joints in long-term follow-up stage (Genzyme Corporation, www.genzyme.com ). Cell Therapies are being investigated successfully in applications to treat infectious diseases such as AIDS, repair spinal cord injuries, strengthen immune systems, and treat neurological disorders such as Alzheimer’s disease, Parkinson’s disease, and epilepsy. Positive results have been reported in treating arteriosclerosis and other cardiovascular diseases, congenital defects, breast reconstruction, and liver insufficiency. Successes have also been reported in development of autologous cancer vaccines ( 1 ). Developers of such products logically seek safety and efficacy in clinical trials. Strong positive results are highlighting the ever-widening fields of application and increasing numbers of registered clinical trials. Contract Manufacturing Support of Clinical Trials: Many developers are us...
Defining the optimal market entry strategy for a vaccine is challenging. Worldwide, vaccine markets are commoditized andvery heterogeneous. In addition, with growth and evolving technology, the business model in the vaccines sector is changing. From the traditional vaccine model, constituted mainly of pediatric vaccines used to prevent a well-known series of viral and bacterial infections in large cohorts of healthy patients, we are seeing the emergence of a more pharma-like model that has been stimulated by new technologies, innovation, and growth. This new model involves higher R&D expenditure, a primary commercial focus on developed countries, and premium prices. The vaccine market was estimated at US $16.3 billion in 2007 and is growing fast with an expected compound annual rate of 13.1% during 2008–2013 compared with 6% for the rest of the pharmaceutical sector. The recent approval of Sanofi Pasteur’s meningitis vaccine (and its release of six other inoculations including one for bird flu) illustrate...
The recent product recalls of PedvaxHib and Comvax vaccine batches are a reminder that the control of vaccine manufacturing processes is of the highest importance. This rings especially true because the target population for these two products is children under the age of five. The Hib vaccine guards against meningitis and other serious infections caused by the bacterium Haemophilus influenzae. In this particular recall, type b vaccine was tested and determined to be free of contaminating microorganisms before being released to the market. However, postrelease surveillance of the sterilization methods used in the manufacturing process showed that the presence of Bacillus cereus bacteria in the batch could not be ruled out. A Quality Risk Management Approach Earlier this year the European authority published new guidance for the control of aseptic processing and for quality risk assessment. Because these two new documents affect the manufacturing of biopharmaceuticals, the guidance for the preparation ...
Chromatography media and methods have evolved continuously since their introduction a half century ago. Traditional methods use columns packed with porous particles. They still dominate chromatography applications in the field of virus purification, but the past 20 years have witnessed the ascendance of alternative supports, namely membranes and monoliths. These newer media exploit the familiar surface chemistries — ion exchange, hydrophobic interaction, and affinity — but they use unique architectures that offer compelling performance features. The Architecture of Chromatography Media A monolith can be defined as a continuous stationary phase cast as a homogeneous column in a single piece ( 1 , 2 , 3 ). Monoliths are further characterized by a highly interconnected network of channels with sizes ranging 1–5 µm. The adsorptive surface is directly accessible to solutes as they pass through the column. The current generation of preparative monoliths have bed heights ranging from a few millimeters to a few...
Combined advances in molecular biology, cell biology, and genomics have led to a wealth of new information about cellular processes. A growing understanding of the fundamentals of cell biology is now being translated into products that use an approach to exert a biological effect that is different from that of most biologicals currently on the market. To date, most biological products consist of highly purified proteins with a specific activity that alleviates or stops the symptoms of a certain condition. Increasingly, however, the “next generation” biologics exploit knowledge gained in cell biology to directly interact with specific cell types or receptors. Such highly specific interaction can direct them to activate or inhibit the signaling cascade of a specific pathway, generating a specific local or systemic biological effect. Another application would be in exploiting metabolic capabilities of an organism or occupying a niche that would otherwise be occupied by a pathogen. What most of these second-g...