2010

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…

The Time Has Come for Automation in Bioprocessing

    As early as 1997, automation was ready to offer potential benefits to the bioprocess industry (1). Professor Bernhard Sonnleitner of the Zürich University of Applied Sciences’ Institute for Chemistry and Biological Chemistry suggested a “standard operating procedure” and pointed to the opportunities, requirements, and potential pitfalls of applying the principles of automation to bioprocess development and operations. If “boring and less interesting routine tasks” could “more efficiently and reliably be handed down to machines,” he explained, then personnel…

Minibodies and Multimodal Chromatography Methods

    Small, genetically engineered immunological constructs are being developed industry-wide for a growing range of in vivo applications. Examples include Fab, F(ab’)2, single-chain (sc) Fv, bis-scFV, diabodies, minibodies, and single-domain antibodies (1). Their small size potentially gives them access to tissues that are poorly accessible by intact antibodies; rapid clearance from blood and nontargeted tissues; lower immunogenic response; and eye-drop, inhalant, or oral administration. We report here on purification of an affinity-matured, humanized, antiprostate stem-cell antigen (PSCA) minibody for…

Biopharmaceutical Information Infrastructure 2.0

    This two-part article explores related tools and technologies that biopharmaceutical companies can leverage to build an efficient mechanism for capturing and delivering valuable information. In BioProcess International’s December 2009 issue, part 1 of the series focused on infrastructure selection and how hardware, software, and information systems form a kind of ecosystem (1). Simplicity, sustainability, and scalability can be achieved only when that trio is designed holistically. Part 1 further explored structured data capture and analysis tools, whereas this…

Microanalytical Techniques for Identifying Nonprotein Contaminants in Biologics

Proteins can aggregate at any point during pharmaceutical manufacturing. Regulatory agencies pay special attention to aggregates that can enhance immune responses and cause adverse clinical effects and those that can compromise the safety and efficacy of a drug product. Biopharmaceutical companies have stringent quality control (QC) procedures in place to ensure that their final products are free of contaminants and defects, including protein aggregates. Trained QC inspectors, however, can typically see product defects or particulate material only as small as…

Is Bovine Albumin Too Complex to Be Just a Commodity?

    For decades, the complexity of albumin has been researched extensively, yet many manufacturers and users of the protein have treated it more as a commodity. Because albumin has been readily available, suppliers and purchasers alike have frequently relied on more obvious measures of “purity” and other minimal release criteria to make their decisions. If a lot does not perform well in practice, the typical supplier’s response has been to investigate the manufacturing process for deviations, then correct them…