TBD’s team facilitates technology transfer to ensure the seamless adoption of any existing methods and processes for continuance of work. Based on the maturity level of the technology, ranging from lab-scale proof-of-concept to commercialized GMP methods, the transfer may include modifications to production techniques, quality control standards, and key documentation. This documentation could involve batch records, process validation data, and equipment qualification. All this expedites the initiation of activities in the new facility while ensuring regulatory compliance.
The primary objective is to replicate the original work/production environment, guaranteeing consistent API quality, efficacy, and safety. Ultimately, the aim is the smooth scalability and commercialization of API production in a cost-effective manner.