2010

Effect of Sterilization on the Mechanical Properties of Silicone Rubbers

    Silicone rubber is widely used in the pharmaceutical industry, where sterilizability is an essential requirement for all fluid transfer equipment. Pharmaceutical products are sterilized frequently and repeatedly by high-level energy and/or chemical vapor to eliminate bacterial surface contamination. Such treatments may also affect the molecular structure of silicone rubbers, causing changes in their physical properties and performance. Several studies on this topic have been reported; until now, however, no systematic investigation has been performed on the effect of…

Isolation of Novel High-Osmolarity Resistant CHO DG44 Cells After Suspension of DNA Mismatch Repair

    Recent technological advances in cell line and bioprocess development have driven significant improvements in product titers and enabled scientists to accelerate product development timelines (1). Despite those successes, many limitations in developing cell lines for biotherapeutics remain. One example in fed-batch cultures is an apparent paradox: when cell growth is inhibited by high osmolarity after multiple additions of concentrated nutrients intended to enhance cell growth and protein production. Generation of novel host cells to overcome specific bottlenecks found…

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,…

Road Map to Implementation of Single-Use Systems

        The Bio-Process Systems Alliance (BPSA) is an organization of equipment suppliers, service providers, and users in the biopharmaceutical industry whose shared mission is to facilitate implementation of single-use technologies in biomanufacturing processes. A key focus of BPSA’s core activities is to educate users and develop guides that help safeguard the quality of drugs and therapies produced with single-use process technologies. As an extension of its technical guides and white papers, BPSA realized the importance of developing…

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…