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strap operational goes excellence here www.pharma-mag.com Figure 3: Lean applied to chromatography, comparing a classic step with 1st generation tools and a modern step with current tools. designed to provide maximum flexibility and to simplify and speed up bioprocessing for scalable and smooth operations from fermentation through to purification. Such technology helps to achieve operational excellence through the removal of unnecessary steps, whilst at the same time allowing facilities to become incredibly flexible and adaptable to the changing needs of the market. Conclusion There is absolutely no doubt that bio/ pharmaceutical manufacturers must critically evaluate their processes to determine if they are running at an optimum level. For biopharmaceuticals, a switch and focus to the mass production of monoclonal antibodies means that it is now more important than ever to ensure that development and manufacture is as efficient and economical as possible. ‘Trimming the excess fat’ enables manufacturers to do more with less — and will result in reduced costs, increased productivity and, ultimately, delivering much better value for money. A couple of trends to keep an eye on during the coming decade are 1. efficient manufacturing of biopharmaceutical proteins at widely varying scale and fast changing schedules 2. small-scale, flexible technologies for rapid experimentation and efficient production of small volumes used in testing, clinical trials and small patient populations. Disposable solutions and “ready-to-use” products offer the required manufacturing flexibility to cope with the changing demands of the industry, while both upstream and March/April 2009 downstream processes are becoming increasingly integrated and more industryfriendly. Continued improvements in chromatography (capacity, throughput and quality) and membranes (such as reduced need for filter area) will be complemented with numerous approaches to improve ease-of-use and increase efficiency. Suppliers to the bio/pharmaceutical industry will need to take these trends and developments into account, and companies such as GE Healthcare will be working closely with the industry to provide the necessary tools to achieve operational excellence. But we are not just looking at short-term issues. It is important to recognize the challenges facing bio/ pharmaceutical production during the course of the next decade, which includes flexible development and manufacturing, multi-product facilities, and tackling the issues of biosimilars and generics. Regardless of whether you are a contract manufacturer or produce your own bio/ pharmaceuticals, there are huge pressures on the industry to develop operational excellence — and the current economic climate prevents investing vast sums into completely redesigning development and manufacturing processes. But naturally, the global issue remains to never lose sight of the overriding need to provide innovative medicines. More information Günter Jagschies, PhD Senior Director, Strategic Customer Relations GE Healthcare, Uppsala, Sweden. guenter.jagschies@ge.com References 1. V. Bornsztejn and M. Ebbens, “Leaning the way in Bioprocess,” www1.gelifesciences. com. 2. http://en.wikipedia.org/wiki/Sakichi_Toyoda. 3. B. Kelley, “Very Large Scale Monoclonal Antibody Purification: The Case for Conventional Unit Operations,” Biotechnol. Prog. 2007, 23, 995-1008. 4. G. Jagschies, “Quo vadis? — where are we heading biopharma?” BioPharm International, in print. 5. Biotechnology Medicines Survey (2004) www.phrma.org. 6. Biotechnology Medicines Survey (2006) www.phrma.org. 7. C. Driscoll, “A Lean Version of Lean,” www. contractpharma.com (June 2006). 8. G. Jagschies, K. Lacki, et al., “Accelerated Development of a Downstream Purification Process for Production of a Monoclonal Antibody: a case study”, presented at Recovery of Biological Products XIII, Quebec, Canada, June 2008. 9. “Anion Exchange Purification of Mabs: Weak Partitioning Chromatography,” S. Vunnum, presented at ACS, BIOT Division, San Francisco, September 2006. 10. “Current and future advances in development of downstream processes for purification of monoclonal antibodies,” H. J. Johansson, presented at IBC Bioprocess International Conference, San Francisco, November 2006. Capto, MabSelect, MabSelect SuRe, PreDictor, ReadyToProcess, Sepharose, are trademarks of GE Healthcare companies. 11. G. Jagschies, K. Lacki, et al., “Accelerated Development of a Downstream Purification Process for Production of a Monoclonal Antibody: a case study,” presented at Recovery of Biological Products XIII, Quebec, Canada, June 2008.
THE WORLD FORUM OF THE PROCESS INDUSTRIES www.achema.de strap solid goes dosage here www.pharma-mag.com Be part of the bigger picture ... ... and see innovations of today for the solutions of tomorrow The global appeal of ACHEMA gives you a competitive edge by allowing you to see the bigger picture. ACHEMA attracts engineers, chemists and decision makers from around the world to a single venue to showcase solutions, share ideas and interface across technology disciplines. ACHEMA's multi-theme approach provides a fresh global perspective on cutting-edge products and technologies that will improve product yields, enhance quality, optimize raw materials’ use and reduce energy costs. Be better prepared for the challenges to come – Attend ACHEMA. ■ CHEMICAL ENGINEERING ■ BIOTECHNOLOGY ■ ANALYTICAL TECHNIQUES ■ FLUID HANDLING ■ PROCESS AUTOMATION ■ PHARMACEUTICAL TECHNOLOGY ■ THERMAL AND MECHANICAL PROCESSES ■ SAFETY ■ ADVANCED MATERIALS ■ ENVIRONMENTAL PROTECTION ■ RESEARCH ■ SPECIAL SHOW: INNOVATIVE CONCEPTS FOR THE USE OF RESOURCES 4,000 EXHIBITORS ■ 180,000 ATTENDEES ■ 30,000 EXECUTIVES ■ 100 COUNTRIES ■ 900 LECTURES www.dechema.de March/April 2009
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