the goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realization (ich q10)
. this knowledge forms the basis for the manufacturing process, control strategy, process validation approach and ongoing continual improvement. it means that technology transfer occurs through the entire lifecycle of biologics. for companies that need to collaborate with cdmos, technology transfer is a routine and frequent operation, and also faces greater challenges than the transferring within the same company.
tot biopharm has established a comprehensive technology transfer platform in accordance with the pda tr65 technology transfer, who guidelines on “the transfer of technology in pharmaceutical manufacturing”, ispe technology transfer guidelines and other related regulatory guidelines. adhering to the concept of “quality first, innovation assistance, and mutual growth”, and following the principle of mutual trust, our team actively communicate process details, establish reasonable control strategies, and are generous in sharing project experience to achieve efficient technology transfer and facilitate smooth implementation
technology transfer standard management procedure
core technical staff with 10 years of experience
comprehensive risk management system
late-stage process transfer and scale-up experience