Abstract
Technology transfer is a complex technical process that does not often receive the resources or considerations that it needs
to ensure success of complex manufacturing processes. Ideally, technology transfer should be managed by a dedicated division
or specialist group, which is one of the benefits gained by outsourcing manufacturing projects to an established contract
manufacturing organization (CMO). A dedicated team knows that technology transfer programs are not always straightforward,
quick, or easy to perform and that there will always be challenges to overcome and problems to resolve to achieve success.
Their experience will also have taught them that clients often have very little idea as to what the transfer process involves,
which means that the development of a trusting relationship between the client and the CMO is essential.
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At many stages during biopharmaceutical product development, it will be necessary to transfer processes from one place to
another. Whether this is internally between teams within a company (for example, from the process development team to the
scale-up or manufacturing team) or externally, from one company to another, the key objective is to execute the transfer with
minimal disruption or unnecessary cost. This can be an overwhelming proposition for small- to medium-sized start up companies
(usually with an academic or research background). These companies will prefer to transfer early-stage processes to a CMO
for the first time—for scale-up and manufacture of Phase ½ clinical trial materials—and have limited experience of scale-up
or the regulations and expectations surrounding a current good manufacturing practices (cGMP) process. Poor planning, unclear
documentation, and bad communication all can lead to an inefficient transfer program, and more often than not will lead to
the receiving team having to develop parts of the process that have already been established. Any inefficiency in the technology
transfer program will inevitably result in delays in production, with the related theoretical loss in revenue and additional
increases in the cost of the transfer. It is therefore essential to put serious time and resources into the planning stage
of a technology transfer program.
A Stitch in Time
There are no fool-proof strategies that can guarantee a smooth technology transfer, but certain factors have a large influence
on success: meticulous planning, technical understanding of the manufacturing processes, and good communication. A strong
emphasis need be placed on a risk-based approach. This involves the identification of risks, both technical and scientific,
and logistical, at an early stage, to develop avoidance or mitigation strategies far enough in advance to help keep the transfer
program on course. This kind of strategy relies on a highly knowledgeable team of people who have the necessary experience
to be able to anticipate the issues that may arise, and excellent communication between the sending and receiving units.
For a CMO, one of the biggest challenges in technology transfer can be dealing with client expectations. For first-timers,
the idea of technology transfer can seem quite simple and straightforward: "We've developed this process at our facility—how
hard can it be to do the same thing in a new place?" The truth is that even transferring the simplest process will be a complex
progression of planning, testing, and optimizing, especially considering that most biotech products being transferred to a
CMO will be moving into clinical trials with the intention to eventually manufacture commercially. This should mean that processes
are, at this stage, being looked at critically to assess suitability for scale-up and regulatory compliance. Clear communication
and the development of a good relationship between both parties is clearly of benefit to all from the very start of the project.
