Process Development
Our expertise in technology transfer and scale up ensures that the final product will be suitable for large scale manufacture and commercialization. We can provide small-scale proof of concept prototype batches, manufacture clinical trial materials; perform scale up manufacturing and registration batch manufacturing as well as perform product transfer and validation services in preparation for Commercial Manufacturing
At Bora, we understand how critically important technology transfer and scale up ability is to the success of your product. We pride ourselves not only in developing robust and reproducible manufacturing processes, but also in understanding the regulatory requirement for product transfer.
To ensure a successful technology transfer, Bora forms a collaborative cross functional team comprising the necessary skills and knowledge to ensure that the technology transfer occurs successfully and in a timely manner. Our team develops a written control strategy that considers all the possibilities and focuses attention on critical points in the process and equipment. Additionally, we review the process flow for inputs and outputs that may impact quality. Finally, we track the key metrics such as repeatability and precision to ensure success.