Tech Transfer Mantra #1
Manufacturing is the Customer
Long-term, the Manufacturing/Operations team will own the execution manufacturing process well after the initial start-up. They will be responsible for delivering the product on schedule and at the projected cost. Therefore, all groups must acknowledge that when technology is to be transferred, the Manufacturing group is the customer and ultimate decider of what will be implemented. The Manufacturing team has many start-up responsibilities as well; for example, it should be the responsibility of the Operations team to ensure that the team is well trained on the incoming process, that the facility receiving the process – the equipment, utilities, etc. – will perform as promised, and that any new equipment or facility modifications are completed in time for the first engineering runs.
But the idea that the Manufacturing team is the decider can be challenging for some - it can require an ego check. But collective success depends on everyone to be able to check their egos and have clear decision-making paths. Since the Manufacturing must own and operate the process after the start-up team has left, they are the owners and deciders about what will go into the plant.
This said, before decisions are made, PD should attempt to influence Manufacturing, lobby for why option #1 should be implemented, etc.
I was participating in a new product start-up years ago[1], and it was an interesting one. The product had such unique properties, even the development of a pilot-scale recovery process was a challenge. Through some good old-fashioned ingenuity, the team came up with a process that was an interesting extension of another process we had used before, but with a twist. This “twist” process worked great at pilot scale, but do “twist” processes scale up?? We weren’t certain, and we knew the physics of the larger-scale system was different. Further, we were hard pressed to build the scaled-down model for this step.
The most direct approach to this was to modify the operation of one piece of separation equipment to suit the needs of the separation. This process was demonstrated at lab and pilot scale to be effective but we we uneasy. Before scale-up, the team engaged an outside expert consultant, and they felt that the approach stood a reasonable chance of success, but could not guarantee it, as it has not been demonstrated at full scale elsewhere in their experience.
Understandably, in discussions with the Manufacturing team, there was some concern due to this lack of precedent. Critically, because everyone had bought into Mantra #1 - Manufacturing is the Customer - the process development team designed a back-up approach utilizing different equipment. The plant throughput would be cut in half, increasing product costs a bit and requiring more plant time, but this back-up could be implemented quickly should the novel approach fail to scale up.
You can read more about this start-up in our paper. Suffice to say here that the reluctance of the Manufacturing team to rely too much on plan A, and the flexibility and partnership of the PD team to agree to design a Plan B, resulted in a great result when Plan A didn’t scale-up well.
It can pay big dividends to think a lot about your relationships well in advance of start-up. Building up that trust – and as important – and defining the operating relationships will serve you well. If you are preparing for a technology transfer and would be interested in a chaperone from someone who has done it many times before in many different ways, feel free to reach out and we can talk about how Berkeley BioProcess can help maximize your start-up success.
[1] Hill PW, Benjamin K, Bhattacharjee B, Garcia F, Leng J, Liu C-L, Murarka A, Pitera D, Porcel, EMR, da Silva I, Kraft C, “Clean manufacturing powered by biology: how Amyris has deployed technology and aims to do it better”,
Journal of Industrial Microbiology & Biotechnology, 07 October 2020,
https://doi.org/10.1007/s10295-020-02314-3