 |
        |
     |  |
|
The process of bringing a biotech product out of research into commercial production may be more difficult, and fraught with greater risk and danger, than original drug discovery. The translation of a new idea from initial concept to a robust, cost effective manufacturing operation requires the interweaving of diverse disciplines and specialized knowledge, covering primary science, as well as regulatory affairs, engineering and operations management.
Early identification of the strategic issues related to scaleup reduces the risk one will proceed down a non-optimal path. Consideration from the start of the strategic issues facing commercialization increases the probability of success with a process that is inherently complex and uncertain. As a product moves through each stage of clinical development, the production process also moves toward a higher level of control, characterization and compliance with current Good Manufacturing Practice (cGMP). At various stages of development, expectations of regulatory agencies increase. While regulations are not secret, two issues arise that make them difficult to define. The first is new products and processes often lack predecessor models, and therefore negotiation with the agency over specific requirements is needed. The second is the activities by which one can characterize and validate the process ranges from minimally acceptable to overkill. These ambiguities in the level of detail that is required often lead companies to do (and thus spend) for more than is necessary, and some become paralyzed by indecision while they try to decide how much they should do. In reality, building a commercial manufacturing capability is not so uncertain, but it does require foresight and planning, especially with a view towards the long term goals of the organization. The decisions one makes early on can have a profound effect on the ease with which a product moves to commercialization. 
Let SMW help you Let Strategic Manufacturing Worldwide strengthen your manufacturing operations.
Let Strategic Manufacturing Worldwide address your outsourcing needs.
In the areas of manufacturing and development, whether in-house or outsourced, Strategic Manufacturing Worldwide has the expertise to help you succeeed. Contact SMW at info@smwbiotech.com.
|
|