In todays biopharmaceutical pipeline, monoclonal antibodies are a predominant modality for a broad range of clinical indications, including inflammatory disorder, oncology and infectious diseases.More than two-dozen antibody-based products are already in the market.In 2004, of the 12 new biopharmaceuticals gained approval in the US and EU, 6 were antibody-based products.Most antibody therapies require high doses over a long period of time, which requires large amount of purified product per patient.Therefore manufacturing capacity to meet the demand of antibody production is a real challenge.It is strongly desirable to have highly productive and consistent manufacturing processes.In addition, speed to market is critical to deliver the health benefit to patients fast and to achieve business success.For early stage clinical studies (Phase I and II), an initial standardized platform process is usually applied to satisfy the material demand and quality requirements within a short period of time despite of the relatively low productivity and robustness.Once the product candidate is proven to be safe to the patients according to the early phase clinical study, the process is further optimized to maximize product yield and process robustness and to reduce the cost of goods for commercial manufacturing.