Process Development

Technology Transfer and Scale-up

HIGH QUALITY, ROBUST AND REPRODUCIBLE MANUFACTURING PROCESSES
 

 

Bora’s expertise in technology transfer and scale-up ensures that your final product is suitable for large scale manufacture and commercialization.

We provide small-scale proof of concept prototype batches, manufacture clinical trial materials, perform scale-up manufacturing and registration batch manufacturing. We also offer product transfer and validation services in preparation for commercial manufacturing.

Our expert teams 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 requirements for product transfer.

 

Our quality process

We form a collaborative cross functional team comprising the necessary skills and knowledge to ensure that your technology transfer is efficient and timely.

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 and we track key metrics such as repeatability and precision to ensure success.