Xcyte Therapies has recently introduced a bioreactor-based process for the GMP manufacture of autologous activated T cells, Xcellerated T Cells™, for clinical trials. Using a single customized disposable 20-L Cellbag™ with a working volume of 10 L on a customized Wave Bioreactor platform (Wave Biotech, Bridgewater, NJ), the Xcellerate™ III Process has supplanted the 60-L static Xcellerate II Process that used 60 bags cultured in a standard incubator. Compared to the Xcellerate II™ Process, the Xcellerate III Process significantly reduces the overall labor, the number of culture containers, bag spikes, and sterile connections required, as well as reducing the process volume and the cost of goods, while more than quadrupling the final cell density and doubling the facility capacity. These process improvements are achieved without compromising final product composition or quality…
Tag: <span>contract manufacturing</span>
Within the United States, greater than 90% of the available transfusible blood products are collected, processed, and distributed by regional blood centers. The remaining blood products are collected by hospital-based blood banks and are usually provided only to patients in the collecting facility. The “region” in which a blood center offers services (i.e., collecting blood from volunteer donors and providing blood components to healthcare facilities), is usually an arbitrarily and independently defined group of contiguous counties surrounding a major metropolitan area. However, the borders of the region can be elastic and easily altered by gaining or losing access to donor groups or customers. It is not uncommon for a geographic area to be simultaneously “claimed” by neighboring competing blood centers. America’s Blood Centers (ABC) is a not-for-profit trade organization that provides services and advocacy for independent not-for-profit regional blood centers. ABC’s seventy-five members collect approximately 45% of the country’s blood products…
Contract manufacturing of recombinant protein drugs and vaccines, as well as other biopharmaceuticals, has been the focus of considerable interest during the past decade. Fueled by a strong clinical development pipeline, primary manufacturing of biopharmaceuticals on a contract basis has attracted multinational industrial concerns willing to invest on the promise of potentially higher returns than are experienced in the production of traditional small molecule drugs. Biopharmaceutical contract manufacturers have made significant contributions to the development and subsequent commercialization of a few highly successful products. However, despite strong growth, consistent profitability has been elusive. The market has changed overr the past decade as customer projects progressed from process development through market launch. Now that several preeminent market players have successfully made the difficult transition from clinical to commercial supplier, what has been learned and how is the market expected to evolve over the next five years?…
The revolution in biotechnology has led to 133 biotechnology-derived medicines being approved by 2001 with sales of $22 billion. This is less than 10 percent of today’s total pharmaceutical market, but it is a rapidly growing sector. Biologics are predicted to grow to nearly $50 billion by 2008. Marketed biopharmaceuticals include several blockbuster products with multibillion-dollar sales. In recent years, biotechnology-derived therapies represented 10 percent to 20 percent of all new approved molecular entities and hundreds more are in development, including nearly 200 proteins in late-stage trials. Microbial and mammalian expression systems are typically used to produce biotherapeutic proteins (many companies are also working on transgenic expression systems). Microbial cultures (typically, Escherichia coli or yeast) are used to produce smaller, less-complex proteins or those where specific modifications, especially glycosolation, are not required…
Long-term growth of the biopharmaceutical industry is increasingly relying on outsourcing to overcome the current capacity constraints, especially for monoclonal antibody production. Companies are often reluctant to commit to building multimillion dollar manufacturing facilities for potential products with no guarantee of approval. Therefore to offset risks, companies will enter into contract manufacturing arrangements…