Scale up and Commercialisation
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The development of new chemistry-based products for life science markets requires the expertise of talented researchers. However, these same researchers are typically not prepared to solve the many other critical problems necessary for successful commercialization. Without the requisite expertise in scale up and commercialization, many early-stage companies find that competitors beat them to the market or resources run out before success can be achieved.
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Scale up and Commercialisation
- 2. Scale-up is generally defined as the process of increasing the batch size. Scale-up of a process can also be viewed as a procedure for applying the same process to different output volumes. “scale-up” simply means enlarging the output by increasing the speed.
- 3. some of the more common scale-up errors are: • Scaling based on wrong unit operation mechanisms. • Incompletely characterized equipment, e.g., multishaft mixers/homogenizers. • Insufficient knowledge of process. lack of important process information. • Utilization of different types of equipment at different levels of scale-up.
- 4. Unrealistic expectations (e.g., heat dissipation) Changes in product or process (e.g., altered formulation, phase changes,changes in order of addition) during scale-up.
- 5. The scale-up of biotechnology products requires an understanding of the cellular and regulatory mechanisms that govern cell physiology and the biophysical and biochemical characteristics of products. The true measure of successful scale-up is validation of the process at manufacturing scale and ultimate approval of the product.
- 6. Successful scale-up requires that manufacturing personnel be properly trained on process requirements and Good Manufacturing Practices to provide an efficient and seamless transition into commercial production within the shortest time possible.
- 7. In order to scale up and transfer a process successfully from laboratory scale to pilot scale and multiple commercial manufacturing scales, a thorough understanding of the integration of scale factors, facility design, equipment design, and process performance is necessary. A scale-up template spreadsheet can be a useful tool to provide the critical integration of multiple factors.
- 8. Commercialisation is the process of introducing a new process or production method into commerce making it available on the market. The commercialisation process has three key aspects , The funnel. It is essential to look at many ideas to get one or two products or businesses that can be sustained long term.
- 9. Commercialisation is a stage wise process, and each step has its own key goals and milestones. It is vital to involve key stakeholders early, including customers. Commercialisation of a product can raise the following questions When to launch Where to launch Whom to target How to launch
- 10. Commercialisation of biotechnology discoveries has many challenges One of the major hurdles to commercialisation is achieving regulatory approval. It includes not only approval for the drug but also the process by which it is produced. An integrated approach to the product and process development is not taken to their business plan.
- 11. The evaluation of the following 10 factors identified as potentially important in determining the future position of the United States and other countries in the commercialization of biotechnology: financing and tax incentives for firms government funding of basic and applied research personnel availability and training
- 12. health, safety, and environmental regulation intellectual property law university/industry relationships antitrust law international technology transfer, investment, and trade government targeting policies in biotechnology public perception.