Thursday, April 1, 2010 Daily Archives

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…

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…

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…

Single-Use Connections Enable Advancements in Aseptic Processing

    Today’s market demand for new drugs — combined with the difficult economic environment — is challenging bioprocessors to review their manufacturing systems and seek ways to make them more flexible, reliable, and cost effective. Increasingly, biomanufacturers are turning to single-use aseptic processing systems to meet or beat aggressive product-introduction timeframes while controlling costs. Innovative new single-use technologies continue to be introduced, giving pharmaceutical companies greater flexibility for replacing traditional stainless tubing, equipment, and even entire process suites with…

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…

Using Disposables in Cell-Culture–Based Vaccine Production

    A recent private grant of US$10 billion for human vaccine applications illustrates the revival of interest in vaccine science (1). The 2009 response by vaccine manufacturers to the H1N1 pandemic revealed the convergence of three technological developments. First is a revolution in technology: Vaccines are being developed for diverse and unprecedented applications through a number of entirely new approaches. Second is the recent adoption of cultured cell-based production for a growing number of vaccines, such as influenza. And…

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…

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…

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,…

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…