Integration team selecting

Try to select Quality Management tools that the integration team and other staff in your organization are familiar with otherwise invest time in training. 

A Initially a team of five or six will develop a detailed proposal. We will then select a division for a pilot study. The pilot will have a team of about 12 people, half of whom will be full-time. As the integration is rolled out in other divisions, I expect a slightly lower level of effort, as we will have learned from our earlier experiences. We will also use an outside consultant to help us develop our plans and review implementation. 

In the area of documentation systems, there were several managers who had volunteered their site to be the pilot location. A relatively small location (Poole Harbor) was selected because while it had numerous documentation systems, it was also determined that the overall implementation time would be fairly short. This provided feedback in an expeditious fashion. The remaining managers who had volunteered their sites were used as part of a pilot review team to keep their interest and support active. They actually started to implement the protocols for a few of the documentation systems on their own, in advance of the roll out at their sites. They also became key proponents of the corporate-wide roll out of the overall integration effort, based on their involvement in just this one area. 

Chimeric antibodies can be expressed in mammalian cells by introducing the recombinant DNA that codes for the antibody into the cells and selecting for the rare cell that has integrated the DNA into its own chromosomes and then expresses a new protein — the desired antibody. Additional genetic manipulations of the mammalian cells are then required to select cells that secrete large amounts of the recombinant protein. Following this research and development model would theoretically lead to successful monoclonal therapies, but in practice, it had never been accomplished before the IDEC team developed rituximab. 

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