Scalability – Why is it so important?
- Provides confidence in R&D decisions since equipment capabilities are well established, which streamlines the R&D process
- Lowers project risk
- Makes the ultimate move to commercial-scale manufacturing much more efficient
- Saves time throughout the validation process
- Simplifies validation documentation
- Saves money
When companies are in development of new assays, the last thing on their minds is how the assays will eventually be manufactured. They're focused on getting the chemistry right, selecting the right membranes and getting the flow characteristics right, and then getting through clinicals. Unfortunately, in this process what is being missed is arguably one of the most important elements in the overall project – what equipment will be used to manufacture the products. And even more important how will it be scaled up from lab and development scale to high volume manufacturing. Which one would assume would be the ultimate goal of any successful project.
It is vitally important to involve an experienced equipment partner in the very design of the product during the development stage. This will help avoid obstacles in the scale-up process and aid greatly in the required process and equipment validation efforts that are necessary before the products can be actively marketed.
At Kinematic we often find ourselves deeply involved in scalability discussions. This is in part because we focus so much of our attention on helping companies in their early-stage development as well as their commercial-scale manufacturing. We have in fact developed several standard modules and platforms that have been designed with scalability in mind from the beginning. The idea of taking a dispensing process, for example, from dispensing on cards on the bench (our Matrix™ 1600) to dispensing on continuous webs in a reel-to-reel process (our Matrix™ 6300) where only the method of transport changes, makes the validation effort far less daunting and far less expensive.
The majority of Kinematic Automation’s workstations and manufacturing platforms were designed with scalability as a paramount requirement. Contact us to learn more.