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…
October 2008
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…
Statistical Approach to IgG Binding on a Strong Cation Exchanger
“Combine All Files†Maps
Many proteins are regulated by posttranslational modifications (PTMs) such as deamidation, phosphorylation, and glycosylation. Documented effects of PTMs include changes in enzymatic activity, interactions with other proteins, subcellular localization, and targeted degradation (1, 2). Also these physicochemical modifications may also affect receptor binding (3) or higher order structure (4) and result in clinical effects such as changes to bioactivity, immunogenicity, and bioavailability (5). The development of analytical technologies to rapidly interrogate protein structure also has direct relevance to the biopharmaceutical…
How to Improve Your Implementation of Two-Dimensional Preparative HPLC
The biologics and natural product industries rely heavily on separation technology. Sample analyses are undertaken on the analytical scale, and isolation and purification are undertaken at the preparative scale. Key target components are often isolated to provide standard reference materials for future product quality assurance testing. These products are often very complex mixtures, requiring separation systems to have a high peak capacity for both analytical and preparative scale separations. A technique gaining popularity among companies that require the isolation of…
Modeling Flow Distribution in Large-Scale Chromatographic Columns with Computational Fluid Dynamics
Column chromatography remains a key unit operation in downstream processing of biopharmaceuticals. For most commercial processes, two to three chromatography steps are used to remove process-and product-related proteins, DNA and adventitious agents. As the biopharmaceutical industry has increased its product offerings and related demands, downstream processes have fast become a bottleneck (1, 2). Many commercial and clinical processes include a number of cycles on one or more chromatography steps to process the harvest from a single production batch. PRODUCT FOCUS:…
BMD Summit
Implement Disposables and Operational Excellence Strategies to Optimize Facility Use and Achieve Cost and Waste Reduction Cost pressures on the biopharmaceutical industry are mounting from domestic consumer demand, the growth of biosimilars, and emerging manufacturers around the globe. For organizations to remain competitive and gain sustainable cost reductions, they must drive innovation and accelerate their rate of implementation of novel technologies. IBC’s fourth international BMD Summit once again provides the latest case studies, regulatory updates, and new strategies for incorporating…