October 2008

The Next Generation of Biologicals and Their Production Systems

Combined advances in molecular biology, cell biology, and genomics have led to a wealth of new information about cellular processes. A growing understanding of the fundamentals of cell biology is now being translated into products that use an approach to exert a biological effect that is different from that of most biologicals currently on the market. To date, most biological products consist of highly purified proteins with a specific activity that alleviates or stops the symptoms of a certain condition.…

Biomanufacturing Capacity Use Showed Solid Performance in 2007

It appears that it will take more than just the subprime mortgage crisis to put a dent in biopharmaceutical manufacturing. Based on results of our latest annual report, capacity use in 2007 remained essentially steady for mammalian cell culture: at nearly two-thirds, 63.3% compared with 63.9% the year before (1). Capacity use represents the percentage of an industry’s production capacity that is actually in use. It measures how effectively manufacturers and industries are making use of their fixed assets. This…

Implementing Single-Use Technology in Biopharmaceutical Manufacturing

In biopharmaceutical manufacturing, single-use components and systems can offer distinct advantages over reusable, cleanable systems. Deciding whether to move to a single-use approach, however, depends on many factors. In a recent review of biomanufacturers and CMOs, the risk of leachable materials entering drug products was highest on a list of end-user concerns, as shown in Figure 1 (1). That’s not surprising in view of the high organic polymer content of disposable components, a general inexperience with such polymeric materials in…

The Emerging Generation of Chromatography Tools for Virus Purification

Chromatography media and methods have evolved continuously since their introduction a half century ago. Traditional methods use columns packed with porous particles. They still dominate chromatography applications in the field of virus purification, but the past 20 years have witnessed the ascendance of alternative supports, namely membranes and monoliths. These newer media exploit the familiar surface chemistries — ion exchange, hydrophobic interaction, and affinity — but they use unique architectures that offer compelling performance features. The Architecture of Chromatography Media…

Cellular Therapy Success Through Integrated Automation

Cell therapies are being developed for a rapidly expanding range of indications. Genzyme Corporation has a treatment of cartilage in joints in long-term follow-up stage (Genzyme Corporation, www.genzyme.com). Cell Therapies are being investigated successfully in applications to treat infectious diseases such as AIDS, repair spinal cord injuries, strengthen immune systems, and treat neurological disorders such as Alzheimer’s disease, Parkinson’s disease, and epilepsy. Positive results have been reported in treating arteriosclerosis and other cardiovascular diseases, congenital defects, breast reconstruction, and liver…

Global Vaccine Commercialization

Defining the optimal market entry strategy for a vaccine is challenging. Worldwide, vaccine markets are commoditized andvery heterogeneous. In addition, with growth and evolving technology, the business model in the vaccines sector is changing. From the traditional vaccine model, constituted mainly of pediatric vaccines used to prevent a well-known series of viral and bacterial infections in large cohorts of healthy patients, we are seeing the emergence of a more pharma-like model that has been stimulated by new technologies, innovation, and…

Optimizing Vaccine Supply Chains Through Quality Management in Manufacturing

The recent product recalls of PedvaxHib and Comvax vaccine batches are a reminder that the control of vaccine manufacturing processes is of the highest importance. This rings especially true because the target population for these two products is children under the age of five. The Hib vaccine guards against meningitis and other serious infections caused by the bacterium Haemophilus influenzae. In this particular recall, type b vaccine was tested and determined to be free of contaminating microorganisms before being released…

The Genesis of New Production Tools for Biotechnology Manufacturers

The biotechnology industry has from the start been characterized by its dependence on innovation. New therapeutics, new indications, new technologies — and the continual drive toward new approaches for optimizing processes — all contribute to getting novel products to the market (and to patients) efficiently and cost-effectively. Most of the technical literature reports on development processes for the therapeutic products themselves. But one element largely ignored forms an essential foundation to the work of the biotechnology industry: How are products…

Products, Services, and Literature

Mixing Options Product: PSU-20 microcompressor Application: Biotechnology/biopharmaceutical development and academic research Features: A new bench-top heavy-duty platform shaker provides three mixing functions (orbital motion, reciprocation, and vibration) and the flexibility of a range of interchangeable platforms. It includes a high-capacity, four-level “hotel” format platform to minimize its footprint. The mixing functions are fully programmable and can be set for continuous or timed operation from one minute to 96 hours to achieve optimum mixing in a single mode or in different…