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Today, product costs, not process science, cause the most concern.
At the time of BioPharm International's first issue 20 years ago, many were uneasy about the science of biotechnology. The use of immortalized cell lines, for example, had only recently been approved, following an earlier prohibition imposed because of fears of transmitting tumorigenic host-cell DNA to patients.
Today, product costs, not process science, cause the most concern. As a result, the interdependence of process and product continues, but with a twist: for biopharmaceuticals to become more affordable, manufacturing economics must improve.
The market for biotech therapeutics is now more than $50 billion. Much of the industry's growth has been fueled by the success of monoclonal antibodies (MAbs). The first MAb for human use was approved in 1986. Today, there are 23 antibodies and antibody-related products on the market, and hundreds more in development.
These high-dose antagonists, however, require large production volumes. The industry has been successful in increasing cell culture yields—from 100–500 mg/L in the early MAb days, to 5 g/L or better today—but these upstream improvements are straining downstream separations. Experts debate whether the solution requires new technology or just better applications of what we have. But no matter which approach is used to meet volume demands, the high cost must be addressed.
Speed to market is also a critical part of this equation, which means companies need ways to accelerate process development, without robustness sacrifices that will lead to scale-up delays later. Another key element is good process control, which fundamentally comes from in-depth process knowledge. Methods like multivariate data analysis, and the application of concepts such as quality by design, can help us get there.
Better manufacturing economics will help the industry address direct cost pressures, such as pricing and reimbursement reductions, and the looming threat of biosimilars. Efficient production systems will also make it more profitable to manufacture niche products and even personalized treatments. This is not only good, but necessary, because the days of blockbusters are coming to an end.
This 20th anniversary issue of BioPharm International addresses these issues by assessing what we have learned over the past two decades, offering current best practices, and looking ahead to future developments.
As we project the industry's forward path, we are also expanding BioPharm's use of new technologies, providing timely information in new formats and media. We have just launched BioPharmNow, our new podcast offering, starting with a series of interviews linked to this 20th anniversary issue. We are also making it easy for you to find information (and share it with your colleagues) through our redesigned, open-access web site, where you can quickly navigate through seven key article categories to find articles of interest.
We look forward to serving the industry for the decades to come!
Laura Bush is the editor in chief of BioPharm International, firstname.lastname@example.org