Technology transfer aims to commercialize products successfully at your contract manufacturing organization (CMO) partner site. This means the manufacturing, analytics, packaging, relevant documentation, and professional expertise should be involved in the process. It is inevitable that problems and challenges can be encountered during the technology transfer of any pharmaceutical product....
A pharmaceutical technology transfer or more commonly known as a tech transfer, is a series of knowledge transfers on a drug product and its established manufacturing processes from development to commercial production. It can also mean knowledge transfer about existing products from one manufacturing site to another by a facility change, a company merger, an acquisition, or a shift to a...
A feasibility study is a trial run that tests your manufacturing steps, materials, and equipment to confirm that your process is designed correctly. During a feasibility study, any differences in the process resulting from the scale, materials, or equipment differences will be exposed. Identified Critical Process Parameters (CPP) may need to be adjusted. The knowledge gained during a feasibility...
To submit a filing to the FDA, whether that be an NDA, ANDA, or 505(b)(2), a product owner must provide technical files containing a pharmaceutical product's chemistry, manufacturing, and control (CMC), safety (nonclinical), and efficacy (clinical) testing results before gaining approval and market access. This includes analytical testing procedures for the drug substances and the finished...