As biopharmaceutical product-development intensifies, what knowledge can be applied from small-molecule manufacturing? Lou Schmukler, senior vice-president of the Specialty/ Biotechnology Operating Unit at Pfizer, shares his perspective on process understanding and control, operational excellence principles, and cultural and organizational transformation.
This period of strong drug development ushered in significant progress and improvement in bioprocessing. With the development of recombinant DNA technology in the 1970s and the creation of monoclonal antibodies, organizations began tackling the challenge of effectively and efficiently producing new biotechnology products. A transformation has long been underway, which has moved biomanufacturing from art to science and has challenged the notion that once characterized biomanufacturing as "the process is the product." In the mid-1980s, achieving yields in quantities of milligrams per liter in monoclonal antibodies was an accomplishment. Today, by incorporating bioprocessing-intensification strategies of the past 15 years, biomanufacturing organizations now routinely can produce yields in quantities of multigrams per liter with an increased emphasis on economics, quality, process robustness, and reliability.The progress in biomanufacturing has been truly remarkable, and we can expect continued progress in upstream and downstream process optimization, new analytical technologies, application of single-use and modular technologies, multiproduct facilities, higher expression-system productivity, and new delivery systems. Growth in emerging markets and the resulting need to address access and affordability issues will challenge current biomanufacturing-supply strategies. In addition, the emergent biosimilar market will require special capabilities from today's biomanufacturing organizations. In short, the continued dynamics of the business and regulatory environment will further drive change.