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.
The biotechnology industry has come a long way in a relatively short time. Over a period of just three decades, the industry
has gone from consisting of only start-up companies to businesses that in aggregate will exceed $125 billion in global revenues
this year. There are more than 30 biotechnology products with annual sales of $1 billion or greater. Biotechnology is the
fastest-growing sector of the bio/pharmaceutical industry with growth highest in vaccines and emerging markets. Biotechnology
companies' pipelines are replete with more than 5600 candidates that are currently in clinical trials and are designed to
treat a plethora of different diseases. Forecasts project that by 2014, seven of the world's top 10 pharmaceutical products
will come from biotechnology companies, according to data from Evaluate Pharma. This impressive performance reflects tremendous
technological advancement and innovation across the biotechnology value chain. Biotechnology has brought extraordinary and
novel therapies to treat cancers, diabetes, pneumococcal disease, rheumatoid arthritis, hemophilia, bone growth, and anemia,
Illustration: Melissa McEvoy; Images Don Farrall/Photodisc.
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.