April 2010

Global Marketplace

Small-Scale Fluid Control Product: Flipper 6650 solenoid valve Applications: Analytical fluid dosing Features: With a pitch of only 4.5 mm, the Flipper 6650 solenoid valve comes in 2/2- and 3/2-way versions that offer performance comparable to 10-mm and 16-mm valves. The media-separated valve is compact and fast-switching, optimized especially for reproducible and precise dosing of aggressive fluids. Because of its compact size, the valve requires smaller internal volume in the connecting plates, thus increasing efficiency of media use, which can…

Cell Line Development and Engineering Novel Approaches to Improve Speed of Development, Stability, Manufacturability, Quality, and Fundamental Understanding

I BC’s sixth annual Cell Line Development and Engineering conference will deliver 37 presentations in a three-day, single-track format for the most valuable and intensive learning experience you can attend. This program has earned its reputation by attracting thought leaders in industry and academia to collectively examine and provide solutions to the industry’s most daunting challenges. For 2010, we developed an agenda that will help you achieve your ultimate goal of improving quality and understanding of your cell lines while…

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…

Are “Land Mines” Hiding in Your Supplier Records?

    A growing trend in US Food and Drug Administration (FDA) warning letters has been citations for “no justified rationale.” Since 2004, warning letters taking companies to task for poorly documented decision-making and risk-assessment practices has more than doubled — from two in 2004 to four in 2008 and five in 2009. These citations are always in relationship to risk-based decisions: sampling (what, how often, and how much), nonconformances and corrective/preventative actions (when is “root cause” actual root cause,…

The Game Changer

Single-use technologies are coming of age and joining other driving forces to reshape the landscape of biopharmaceutical industry. This innovation has created new platforms for bioprocessing, offering competitive advantages and tremendous opportunities to current biomanufacturers. Moreover, the increasing acceptance of disposable systems with proven success will help enable niche products and bring emergent players to the market. The Age of Stainless Steel The discovery of DNA structure in the middle of the 20th century led to numerous breakthroughs in biological…

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,…

Understanding the Basics of Peptide and Protein Production

With strong growth in biologics, large molecules, and biopharmaceutical therapeutics in recent years, the pharmaceutical and biotech industries are increasingly turning toward peptides and proteins in their search for drug discovery targets. While both offer significant therapeutic potential, there are fundamental differences between the two types of molecule. Definitions: Peptides are short polymers formed from the linking of (usually ≤100) amino acids. They comprise some of the most basic components of human biological processes, including enzymes and hormones. The link…

Is Bovine Albumin Too Complex to Be Just a Commodity?

    Albumin is the most abundant serum protein. It serves several functions in vivo: e.g., binding and transport of fatty acids, hormones, and metal ions; maintenance of osmotic pressure and pH; and binding of exogenous toxins and products of lipid oxidation (1). Over time, development of large–scale purification methods have translated those functions into diagnostic, cell culture, and microbiological applications. It is important to note, however, that purification procedures can promote molecular changes and thereby add to the already…

Changes in Raw Material Sources from Suppliers

    Maintaining the supply chain of single-source raw materials is of utmost importance for a biopharmaceutical company’s manufacturing operations. As often happens, a supplier will notify its customer of process changes that might affect the quality or properties of supplied materials. Occasionally, a supplier might notify the customer of substitutions in its own supply chain or other changes in the source of its own raw materials. Customers must conduct appropriate testing using the “new” raw material(s) to ensure acceptable…

Polymers and Additives Used in Fabrication of Disposable Bioprocess Equipment

The materials used to fabricate single-use processing equipment for biopharmaceutical manufacturing are usually polymers, such as plastic or elastomers (rubber), rather than the traditional metal or glass. Polymers offer more versatility because they are light-weight, flexible, and much more durable than their traditional counterparts. Plastic and rubber are also disposable, so issues associated with cleaning and its validation can be avoided. Additives can also be incorporated into polymers to give them clarity rivaling that of glass or to add color…