Flexibility has quickly become one of the most noticeable buzzwords of the bioprocessing industry. Understanding what constitutes a “flexible” process ranges from the simple application of one specific type of technology (e.g., single-use systems, automation, standard controls) to a somewhat extreme concept of a “throw-away” process. But whatever the definition, the factors leading to the need for more flexible approaches to biomanufacture are clear: Rapid, sometimes unexpected, changes in a company’s business situation and/or product portfolio (whether for patients or…
Business
Terminology Management
Effective terminology management is an essential risk-management strategy for biopharmaceutical organizations. With a terminology management strategy in place, organizations of all sizes can use the same terms consistently within and across the various documents and labeling that accompany a product or service. Because such documents are typically created in a collaborative environment, terminology management is the most efficient solution for ensuring that the organization as a whole uses the same terms to describe the same features and functions. With comprehensive,…
Making a Positive Urban Impact
The nonprofit Center of Research Technology and Entrepreneurial Exchange (CORTEX) was formed to facilitate development of two redevelopment areas in St. Louis, MO. Last month, I explained their vision and introduced the participants, along with highlighting an example development on the campus of St. Louis University. This month, I conclude with several more examples. Center For Emerging Technologies The Center for Emerging Technologies in St. Louis is ranked a top-10 business incubation facilities in the United States. In under nine…
The Growing Role of Biobanking in Today’s Medical Environment
For decades, biomaterials such as tissues, blood, and serum derived from clinical testing have played a critical role in drug development and academic research. The recent focus on molecular-based therapies, genomics, and biomarker discovery in today’s medical research have dramatically transformed the way biotechnology and pharmaceutical organizations collect, transport, and store their biospecimens. As the pharmaceutical industry shifts toward a more personalized approach to medicine, the need for high-quality, well-maintained biospecimens is at the forefront of medical research.…
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…
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…
Delivering Affordable Biologics from Gene to Vial
In launching this new series of articles under the theme of delivering affordable biologics, from gene to vial, we intend to examine some of the challenges the bioprocess industry faces. We will discuss the implications of key cost challenges facing the industry, develop an understanding of the economics underlying development and manufacturing, and explore options for driving out cost. We wish to encourage dialogue and debate, so in addition to the articles we will also use webcast interviews…
The Business of Biotechnology
All companies — large and small, biotech included — have felt the pinch of the current (or recent, depending on your point of view) recession. From huge multinational companies to virtual start-ups, all are taking a good hard look at the way they do business. And as it does every year, the 2010 BIO International Convention will offer something for every company and every situation. Business-oriented sessions range from hard-earned experience to provocative new ideas. On the BioProcess…
Rethinking Efficiency
Public and private healthcare providers are under increasing pressure with the demand for better quality drugs and cheaper healthcare on the rise. However, rising costs and time scales for bringing new drugs to market suggest that challenging times are ahead for many pharmaceutical companies. Current trends in US healthcare indicate that almost half of the hospitals across the country have seen a >20% drop in income. With an additional drop in financial donations, many hospital staff budgets are being cut,…
Making a Positive Urban Impact
Like so many other midwestern industrial cities, St. Louis, MO, saw its manufacturing base decline over the past 40 years. Led by the automobile, shoe manufacturing, and defense industries, that decline was coupled with a notable decrease in the city population. From 1950’s high of 850,000 people, the city dwindled to ~350,000 by the 1990s, although its metropolitan area grew to >2,000,000. Accelerating growth of high technology in the 1990s had minimal impact on St. Louis the “old industry” the…