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…
April 2010 Supplement
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…
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…
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…
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…
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…