March 2010

Protein Therapeutics and Aggregates Characterized By Photon Correlation Spectroscopy

    New biological entities (NBEs, therapeutic proteins such as interferons or antibodies) are much more complex than new chemical entities (NCEs), the classic “chemical” active ingredients. First, they are much larger. The average molecular weight of antibodies is ~150,000 g/mol. Second, most NBEs contain three-dimensional structural elements — with the protein secondary and tertiary structure being the most prominent, but quaternary structures are also known for some. The 3D structures are essential for correct bioactivity (1), but they are…

Process Development’s Impact on Cost of Goods Manufactured (COGM)

    Manufacturing throughput (the amount of material a plant can produce per year) is affected by process yield and plant run rate. The higher they are, the more a plant can produce per year, requiring fewer lots to meet annual demand. Although a process development team obviously determines the process yield, the team also determines the impact on the run rate of duration and potential implementation complexity of the entire train of unit operations. Thus, an optimized process maximizes…

Global Marketplace

Laboratory Instruments Product: Cubis laboratory balance and Arium Pro laboratory water purification system Applications: Precision medical and life-science laboratory work Features: International Forum Design GmbH awarded Sartorius the 2010 international iF Product Design Award for two laboratory products in the medicine/healthcare category. Cubis modular laboratory balances can be custom-configured for different working environments. The Arium Pro laboratory water purification system produces ultrapure water quickly, safely, and cost-effectively for chromatography, cell cultivation, and protein purification laboratory applications. Contact Sartorius AG www.sartorius.com…

TIDES® Oligonucleotide and Peptide Technology and Product Development

Moving to Boston, MA, after four years in the western United States (Las Vegas and Carlsbad, CA), the Tides conference continues to be the must-attend event for the industry that grows in attendance each year. The 2010 agenda includes thought-provoking keynotes and featured presentations, a compelling regulatory session, and discussions with CBER, FDA, and European regulatory agency speakers. In separate tracks for each type of molecule, learn more from the new, full-day sessions on CMC manufacturing and analysis and a…

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…

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.…

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…

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…