As most novelists will tell you, if you make substantial changes to the beginning of a story, you may well need to revise your preestablished conclusion. Similarly, as approaches to process design and development change, new tools, technologies, and various shifting “paradigms†also affect the way companies approach final formulation, filling, and finish steps. As yet another ref lection of increased process understanding and quality-by-design’s (QbD’s) holistic approach to biopharmaceutical development, those final steps — traditionally outsourced by…
Author Archives: Cheryl Scott
Emerging Biomarkets
Several smaller-market countries in the Asia–Pacific region are looking to biotechnology as a significant driver for their economic growth. Some present themselves as wide open to foreign investment, hoping to attract partners or contract clients from overseas. Others are working to develop homegrown industry through local research and financing. A few have banded together in an Asian “light†version of the European Union. ASEAN Countries The Association of Southeast Asian Nations (ASEAN) is a geopolitical and economic organization of 10…
Quality By Design and the New Process Validation Guidance
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…
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 “thereâ€â€” 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…