 |
        |
     |  |
|
Bringing Good Ideas to Market The goal of manufacturing is to bring good ideas to market. Far from a trivial pursuit, this is an area in which even the best of companies at times ignominiously fail. In biotechnology it is particularly difficult because of two reasons: first it is a highly regulated industry with many rules, some of which are not intuitively obvious; and second the technology required is frequently novel and depends on the vagaries of living systems. The task of taking a product to market is every bit as taxing as original product development. Underestimating these challenges often results in insufficient resources and planning. The recognition that this is a fundamental problem for all industries does little to assuage the pain of disappointed investors. There is no substitute for experience in planning for the issues that arise in moving a process from research to development. The very act of relocating the operation into a cGMP facility necessitates change. One can move the process, but the new environment will always be different than whatever lab in which it was developed. Even seemingly simple issues such as preparation of solutions by weight rather than by volume may expose the limitations of a process and render the product unusable. Operations under cGMP tend to be very expensive. Typical costs for a product made in large-scale cell culture run between $100,000 and $1 million per batch. This cost is almost independent of the batch size, as it includes documentation, testing, personnel, and plant equipment amortization. Contract manufacturers have as a goal the maximization of their plant usage, and whether the customer uses a 3000 L or a 10,000 L tank, the piping, utilities and attendant controls and equipment are very similar and thus carry a similar amortization cost. The ability to move products efficiently from research to manufacturing is one of the ways good companies distinguish themselves strategically. Let SMW help you Let Strategic Manufacturing Worldwide help your manufacturing operations become truly strategic.
|
|