Vaccines

Trends and New Technology in Vaccine Manufacturing

Significant changes are sweeping the vaccine manufacturing industry. Demand for human vaccines is predicted to grow significantly — in part driven by needs in emerging countries, where only small fractions of their large and growing populations has access to vaccines. Sustained growth is expected to yield a vaccine market of US$25 billion by the year 2015 (1). Relatively low immunization rates in the Asia–Pacific regions represent significant untapped potential for vaccine manufacturers. Growing populations, increased government funding, and increasing personal…

A Convergence of New Products and Technologies Changes the Game

    Vaccine makers are leading the way — that’s something you don’t hear every day. For many years, vaccines were seen as “old-school” and less profitable than other biologic products — and they were the business of just a few huge companies. But thanks to recombinant technology, it’s a real Cinderella story: Advancing technologies led to what’s being called the “vaccine renaissance.” And now, vaccine companies may have something to teach their biopharmaceutical brethren. In April 2004, BPI may…

Using Disposables in Cell-Culture–Based Vaccine Production

    A recent private grant of US$10 billion for human vaccine applications illustrates the revival of interest in vaccine science (1). The 2009 response by vaccine manufacturers to the H1N1 pandemic revealed the convergence of three technological developments. First is a revolution in technology: Vaccines are being developed for diverse and unprecedented applications through a number of entirely new approaches. Second is the recent adoption of cultured cell-based production for a growing number of vaccines, such as influenza. And…

Rapid Assessment of Vaccine Potency

The global vaccine market is growing annually by 16% and is expected to reach $21 billion by 2010 (1). Much of the predicted growth of this market is expected to come from the introduction of new vaccines, either against diseases for which no vaccine currently exists or as second-generation products to replace existing ones. Much research is still centered on developing vaccines to prevent infectious diseases caused by microbial and viral pathogens. This segment is being fueled by a number…

Production of Recombinant Whole-Cell Vaccines with Disposable Manufacturing Systems

Live whole-cell bacterial products have been used as vaccines for many years, and there are currently three such products licensed on the market. Over recent years, however, interest has renewed in this type of product as a delivery system for novel recombinant therapies and vaccines. A number of different organisms have been proposed, such as Escherichia coli and Salmonella species, which might have applicability for such applications. Vaccine applications tend to relate to the potential for low-cost orally delivered products…

Novel Vaccines and Virology

Vaccines have been around a long time — longer than any other biologic medical products. Since the 1700s, when a British doctor inoculated people against smallpox using Variolae vaccinae (cowpox virus), we’ve referred to such immunizing treatments as “vaccines.” Most children in developed countries grow up knowing there will be occasional “vaccinations,” usually injections, required to get into school and stay there (which may or may not seem like a great thing, depending on who you talk to). Similarly, people…

21st Century Vaccine Manufacturing

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…

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…

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,…

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…