By Lonnie Barish, MBA, VP of Business Development and Marketing, Bora Pharmaceuticals
Turning a promising drug candidate into a successful pharmaceutical product involves scaling-up the processes, developed in the research lab, in order that commercial supply can be achieved. The technical hurdles involved in making this transfer can be daunting.
Also, it is not uncommon for changes to be made in the manufacturing process and/or chemistry of a drug product following approval and the changes can continue throughout its life cycle to improve the product. Depending upon the circumstances, there can be changes to the raw materials, production process, equipment train, manufacturing site and/or batch size which can ultimately affect Critical Quality Attributes (CQAs) of a drug or finished product.
Fortunately, pharmaceutical companies can help themselves by planning for scale-up and commercialization if they are doing these Technology Transfers at the earliest stages of drug development.