Establishment of standard production platforms can help vaccine development move a step closer to the commercial, technical, and regulatory benefits increasingly enjoyed by developers of monoclonal antibody (MAb) products. Three recent advances especially will assist vaccine manufacturing development: rapid analytical methods to support evaluation of process design and provide in-process control; and the establishment of supply chains and vendors across Asia for bioprocessing equipment and consumables that meet the highest international standards. Whereas some workers in the field may consider…
Vaccines
The Vaccine Renaissance
The global vaccine industry has undergone a dramatic and well publicized rebirth. Near the end of the 20th century, it faced an uncertain future with increased pricing pressures and liability challenges for marketed vaccines. Many long-standing members of the industry chose to scale back their R&D efforts or abandon them altogether. Today, however, the landscape has changed. Because of a confluence of positive factors (advancements in science and technology, greater appreciation for the role of vaccines as antibiotic resistance increased,…
Biologics New and Improving
By far the most successful applications of biotechnology have been in the medical field. The vaccine industry is undergoing a complete transformation thanks to biotechnology. And cutting-edge research is giving us whole new ideas about disease therapy using nucleic acids and regenerative medicine. Proteins and Other Therapeutics Cancer has been a primary target for many MAb “magic bullets” and a major research area for life scientists over the past quarter-century. Oncologists have identified ∼200 cancers that affect human beings, some…
A Readily Available Source of BSA Consistently Supports Cultivation and Differential Gene Expression
Lyme disease caused by the spirochete Borrelia burgdorferi is the leading vector-borne illness in the United States (1). The natural infectious lifecycle of B. burgdorferi is complex in that it is necessary for the bacteria to colonize both an arthropod vector (the Ixodes scapularis tick, pictured right) and a mammalian host (2). As the bacteria transitions between those two diverse niches, it alters the expression of its major outer surface proteins (Osps) such that expression of those that…
Global Vaccine Commercialization
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…
Optimizing Vaccine Supply Chains Through Quality Management in Manufacturing
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…
The Next Generation of Biologicals and Their Production Systems
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.…
The Emerging Generation of Chromatography Tools for Virus Purification
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…
Cellular Therapy Success Through Integrated Automation
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…
In the Therapeutics Zone
Small molecules are still not providing cures for many diseases, and this is why biological therapies continue to be developed. They often offer greater convenience to patients, as well as longer lasting therapies,” says William Prather, MD, senior vice president of corporate development at the Israeli stem cell company, Pluristem. The therapeutics area at this year’s BIO International Convention will play host to many interesting technologies for producing and improving protein therapeutics, vaccines, and stem cells. Protein Therapies Remain Top…