BioProcess International, November 2012, pg. 31-42
Monoclonal antibodies (MAbs) remain the largest segment of the biopharmaceutical market, but they are not the only recombinant proteins in development. Remember that the first biopharmaceutical approved for sale was recombinant insulin — a hormone — back in the 1980s. And proteins aren't the only recombinant biologics. The sector has expanded since then to include gene therapies and viral vectors, vaccines, and even cells and tissues. Companies around the world are developing such products for cancer, neurological, infectious disease, metabolic, autoimmune, and cardiovascular disorders, to name just the most prominent. And although MAbs are finally fulfilling their “magic bullet” promise, many other approaches are becoming available to drug developers targeting those markets — and others.
Meanwhile, funding challenges are increasing emphasis on manufacturing and development efficiencies. Even though total funding of the biotechnology industry has rebounded since the 2008 recession — from about US$13 billion for the United States industry in 2008 to about $21 billion in 2010, for example — a growing share of that money is going to the less risky investments. According to Ernst & Young's 2011 Beyond Borders report, that means mature and already-profitable companies are taking a larger portion of the financial pie.
At the same time, the average number of drug approvals per year has decreased: from about three dozen in the United States from 1996 to 2004 to under two dozen for the years since. And even though markets are opening up in China, India, and other countries, the cost of doing business on a global scale makes it no easy task to reach them. So biopharmaceutical companies need to curb the rise of development and manufacturing costs. Single-use technologies are helping with the latter in large part. And platform technologies have helped antibody makers shorten development times by starting out with certain rules of thumb — rather than trying out hundreds of available purification technologies, for example, in many different combinations to find what works best for every new product candidate.
Do nonantibody makers have similar options when it comes to their own process development work? As is so often the case in bioprocessing, the answer to that question is “It depends. ..” on the product class; on the expression system; and on the regulatory history of the company, process, and type of molecule.
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