The Vaccine Scene - A look at vaccine history, markets, manufacturing, and overcoming the scale-up dilemma. This article is part of a special section on vaccines. - BioPharm International

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The Vaccine Scene
A look at vaccine history, markets, manufacturing, and overcoming the scale-up dilemma. This article is part of a special section on vaccines.


BioPharm International
Volume 26, Issue 2, pp. 18-20, 57


Jose Castillo, PhD
As the world population expands, the need for human vaccines (to protect ourselves) and veterinary vaccines (to protect our pets and livestock food sources) has dramatically increased. Despite the demand over the past few decades, the industry has fallen behind in delivering new commercialization solutions to answer the needs of the population. Advances in cell-culture techniques have long been a key driver for enabling new vaccine solutions, and now, emerging process innovations and efficiency breakthroughs are solving traditional bottlenecks in vaccine development and production.

This article will review the history of and present advancements in vaccine production through mammalian cell cultivation for both weakened or killed forms of viruses (attenuated life viral vaccines or killed viral vaccines) and surface proteins of viruses or bacteria (recombinant sub-unit vaccines).

A KEY COMPONENT OF PUBLIC HEALTH

Vaccines, or biological preparations that improve immunity to a particular disease, have been around for centuries and still remain vital in the fight to ward off diseases. The term vaccine derives from the work of Edward Jenner (1749–1823), an English physician and scientist considered to be the father of immunology. His seminal work in 1796 used cow pox, or variola vaccinia (from the Latin vacca, meaning cow), to inoculate humans and protect them from smallpox.

The injectable polio vaccine was the first biopharmaceutical mass-produced using cell-culture techniques. It was made possible through the research efforts of Drs. Franklin Enders, Thomas Wellers, and Frederick Robbins, who were awarded the 1954 Nobel Prize in Physiology and Medicine for their discovery of a method for growing the virus in monkey kidney-cell cultures (Vero cells).

Vaccines typically contain an agent that resembles a disease-causing microorganism, and are often made from either weakened or killed forms of the microbe, toxins from the microbe, or a surface protein from the microbe. When they are manufactured to initiate immune system responses in humans and animals that help combat invading enemies, they act as an effective first line of defense against the spread of disease.

THE VACCINE MARKETS

The global human vaccine industry is estimated to be worth $25 billion, with around 600 products currently on the market (1). Revenue is predicted to reach about 10% annual growth rate (CAGR) (2).

The human vaccine market is mainly in the hands of five large corporations that manufacture vaccines for the world's markets. There are small players as well, primarily in developing countries. Some countries, such as India, have a local biotechnology industry developing world-class vaccine manufacturing plants and expertise. Overall, the needs in Brazil, Russia, India, and China (the BRIC) are especially high, as they represent 50% of the world's population and fall behind the rest of the world in terms of manufacturing infrastructure.

On the other side of the equation, the global veterinary vaccine industry is estimated to be worth $5.24 billion, with approximately 2400 products on the market (3). Revenue for this industry is predicted to reach about 5.7% CAGR. The structure of this market is quite different when compared with that of human vaccines. Here, there are also several large, global suppliers. Unlike with human vaccine development, however, there is not a single species to treat. There is, instead, a vast variety of animal species, each with several diseases and specific needs. Consequently, vaccines from some companies are manufactured exclusively in roller bottles, because many batches of different vaccines are produced in parallel and processes using bioreactors have been slow to develop.


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