Our society demands speed and efficiency, and there is no exception in the world of manufacturing pharmaceuticals and biologics. Technology transfer enables companies to manufacture their products without the expenditures associated with new facility construction and deployment. Technology transfer makes this possible through transferring a process, even at a pilot scale, from the process designers and experts to a facility that has capabilities of large-scale manufacturing. This can be particularly appealing to small biotech companies, which are often limited in experience, time, and resources to manufacture their products in-house. The companies that own the technologies are called sending sites, and the facility that they work with to manufacture the product is known as the receiving site. The sending and receiving sites of technology transfer can be the same company, but usually they are not.
Delta Project Management has a client portfolio of both sending and receiving sites of technology transfers, and we anticipate booming growth in this field. Recognizing this evolution, Delta PM hosted a Technology Transfer Night with ISPE, where we heard testimonials from both the sending and receiving sites of technology transfer. We gained insight into Juno Therapeutics’ experience as a sending site to various Contract Manufacturing Organizations (CMO), and we also heard about Boehringer Ingelheim’s experience as a large-scale receiving site and a world-class CMO.
While the sending and receiving sites are partners that collaborate to ensure the success of the released product, they also have unique responsibilities to meet this end goal. As discussed by the panel at the event, this can sometimes mean the possibility of blurred lines between ownership of documents and deliverables. The sending site usually owns deliverables, such as risk assessments, process control strategies, and process descriptions, but they also have the responsibility of ensuring that the manufacturing documentation produced by the receiving site, including batch records and work instructions, is consistent with initial process design. This is particularly important to ensure product comparability when the sending site has multiple receiving sites for the same technology. There is often a wide range of challenges on both sides of technology transfers, yet the plethora of advantages sustain this mutually beneficial partnership structure. As we expand our presence in tech transfer, we will continue to invest in gaining knowledge and experience in this sector to deliver excellent services to Delta PM's current and future clients.