Where were you in 1987, and what were you doing? I’m not too embarrassed to say that I was beginning my last year of high school and paying far more attention to guitar lessons and writing my first novel than what I might eventually do for a career. Meanwhile, the US FDA was publishing a guidance document on process validation that the biopharmaceutical industry has relied on ever since. I’m willing to bet that quite a few readers…
Author Archives: Cheryl Scott
Protein Conjugates
Methods and Materials Thanks to vendors large and small — such as Invitrogen (www.invitrogen.com), ProteoChem (www.proteochem.com), Sigma Aldrich (www.sigmaaldrich.com), Soltec Ventures (www.soltecventures.com), and Thermo Scientific Pierce (www.piercenet.com) — bioconjugation chemistry is a field of many options. For example, amine coupling of lysine amino-acid residues typically involves amine-reactive succinimidyl esters. Sulfhydryl coupling of cysteine residues uses a sulfhydryl-reactive maleimide. Photochemically initiated free-radical reactions offer broader reactivity. Most processes couple small molecules to proteins or proteins to one another (e.g., antibodies…
Cell Culture and Production
Time to market, cost of goods, and reduction of financial risk are major challenges in protein manufacturing. Process intensification can help biotech companies achieve their goals. Already underway in several other industries, implementing this concept shrinks production facility sizes by 10–1,000 times using novel processes and products (e.g., single-use and isolator technologies in biotechnology) to reduce capital and operating costs. The results can be safer, more energy-efficient, and environmentally sustainable manufacturing processes. For example, Gerben Zijlstra (senior scientist…
Speeding Vaccine Development and Production
With infusions of public and private venture capital as well as technological advances, vaccine development is entering a new golden age as one of the fastest growing sectors in the biotechnology industry. In the 19th and 20th centuries, immunization programs eliminated or controlled infectious diseases including smallpox, polio, measles, mumps, and rubella. The biotech era has made significant changes both in the number of companies involved in vaccine manufacture and the production systems they use. BPI CONFERENCE SESSIONS…
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…
Challenges in Developing an Infrastructure Strategy
The idea of “thinking globally, but manufacturing locally” to each market is relatively new to the biopharmaceutical industry. As I mentioned in Chapter 2, vaccine makers are more familiar with the concept already. But many technological and economic factors are making other companies aware of this option. Offshoring clinical trials has been of great interest in the pharmaceutical industry for years now. Is it more cost-effective to make clinical materials “here” and ship them “there”— or to make…
The Collaborative Future: A Case Study
In our February 2010 special report, “The Time Has Come for Automation in Bioprocessing,” one theme that made itself clear was the need for vendors, biopharmaceutical companies, and sometimes even regulators to work together toward the goal of better, faster, and cheaper product development through (among other things) automation technologies. Martin Rhiel of Novaris cell and process R&D told us, “It would be really nice to just buy it and implement it, but this doesn’t always work…Nowadays, the…
Managing the Product Pipeline
In 2007, the biopharmaceutical market represented ~$71 billion: 10% of the entire pharmaceutical market. Therapeutic proteins and monoclonal antibodies (MAbs) account for 98% of all biotherapeutics in development, the rest being blood proteins and enzymes — all the products of recombinant DNA technology. Before the recession hit full on, growth of this market was estimated by some at ~15%. (Now it’s hard to predict at all.) Making biotech drugs consumes huge amounts of time and money, but they…
Growing the Future
The 2010 BIO International Convention isn’t just about biotechnology-derived drugs and vaccines. The biotechnology industry as a whole seeks to address current global needs in other areas as well in light of diminishing resources and other environmental concerns. Biofuels development is entering its second wave. Agricultural researchers are finding ways to improve global access to both food and energy. And health-care policy is taking ethics and environmental sustainability into account while looking for new models that can help…
The Time Has Come for Automation in Bioprocessing
As early as 1997, automation was ready to offer potential benefits to the bioprocess industry (1). Professor Bernhard Sonnleitner of the Zürich University of Applied Sciences’ Institute for Chemistry and Biological Chemistry suggested a “standard operating procedure” and pointed to the opportunities, requirements, and potential pitfalls of applying the principles of automation to bioprocess development and operations. If “boring and less interesting routine tasks” could “more efficiently and reliably be handed down to machines,” he explained, then personnel…