Great Promise - Too Many Expectations?
Nevertheless, the biotechnology field is committed to MAbs and continues to find new ways both to press onward with current processes and—to some extent in reaction to the economic pressures—to develop radically new concepts and technologies that could make monoclonals even more widespread.
Scientists are also trying to understand how MAbs aggregate during long-term storage. This is important if the industry is to achieve economies of scale and reduce costs to the end consumer. Like conventional drugs, antibodies are subject to oxidation and hydrolysis and demidation. Adding protective proteins to the MAbs might help preserve them.
Instead of wedding themselves to the pricey bioreactors, some biotech companies think the way of the future may be to use “transgenic” animals, such as goats and cows, and even corn or other plants, genetically engineered to carry genes for desired antibodies. With that technology, some companies are envisioning MAbs from the milk of transgenic cows or goats, while others are looking to transgenic plants. Both approaches remain in their infancy and will have to make their way through both whatever challenges science holds for them and whatever issues regulators will have.
It remains unclear just where MAb technology might head in the future—will we build the bioreactors we need for established technologies, crack open new processes that yield greater results at less expense, take a direction not yet imagined? The answers, of course, will take time to come.
Academic people at Tufts University found that the avergae length of time FDA-approved MAbs spend in clinical trial was 7.2 years. Then there is another year for the FDA approval process.
Still, the evidence continues to mount that monoclonals are, in large measure, destined to be the "magic bullets" Paul Ehrlich envisioned a century ago.