Welcome to part two on the mental and physical state of tech transfer in drug development and manufacturing outsourcing.
Our discussion was undertaken as part of a biopharma professional’s dissertation for a Master’s Degree in Pharmaceutical Validation Technology at the Technological University Dublin. (read part one here)
Go Easy On Yourself
Humble Editor: “None of the challenges in tech transfer from a biopharma to a CDMO you uncovered in your survey and interviews with outsourcing professionals surprise me.”
[Four were stated in part one, in order of most concerning:
Collaborating effectively within the sponsor-CDMO relationship.]
However, I believe sometimes we are too hard on ourselves as an industry.
How can we say we are ineffective at tech transfer, but at the same time have established a thriving industry of virtual biopharma and start-ups reliant on outsourcing most all development and manufacturing to external partners?
We must be doing something right. So let’s start on a positive note.”
Facility Ready Or Risky?
Layth Ujam: “I don’t think we are performing tech transfer badly, as you say, but we need to be more efficient. As an industry we really don’t learn from our mistakes. I'm still seeing those same issues we had at the beginning of my career 18 years ago.
At the same time, I see we are driving down some inefficiencies through the use of Six-Sigma-type tools such as highlighting waste; value-stream mapping; root-cause analysis, FMEA [Failure Mode and Effects Analysis]; and Kaizen [Japanese business philosophy of continuous improvement].
I'm also hearing companies continuously wanting to do things ‘quicker.’ However, I don’t believe you can keep squeezing timeframes. The science itself has a breaking point; there must be a limit. And no two products are the same.
Instead, I think we must have a closer examination of those tools we are using, and answer questions such as:
What does each transfer need to accomplish specifically?
What's the best practice to ensure that is completed as efficiently as possible?
I don't think we should be so focused on doing tech transfers as quickly as we can. We should always have quality in the back of our minds, with a ‘right-first-time’ attitude in place.
One answer to this, I believe, is to better evaluate the readiness of a facility to accept a certain project transfer. Many companies know this as the ‘facility-fit assessment.’
It includes such things as having a look at the training that might be needed beforehand, and documentation and data management strategy throughout, as well as equipment and capabilities.
Overall for me, this is akin to making the process for the tech transfer as efficient as you are trying to make the process to produce the actual material.
That may mean a certain standardization as well … I think I'm kind of in the middle on that.
But procedures and tools should be firmly in place to assure readiness to start the transfer and run the processes – determined by this use of a facility-fit assessment.
For example, when a CDMO is trying to take on a new customer, they go through their proposal creation stage. Part of that should utilize tools to assess the risk of acceptance.
There should be business-risk and a product-risk assessments for not being fully ready, or capable, of an efficient transfer in.
I’m familiar with at least six or seven areas of risk: product characterization; equipment qualification; cleanroom segregation; storage capacity; staffing (training and resource planning); documentation; and asset capacity.
It’s the CDMO – in collaboration with the customer as the best practice – going through a systematic check of what needs to be in place, and what needs to be monitored. And the same contemplations at the biopharma: Are we adequately set up internally for a productive transfer?
So you can have a standard approach to transferring in that sense. It helps prepare the team receiving and the one sending the product. It helps ensure the CDMO does get all, or at least tries to get all the information and knowledge they need. And it prepares the facility.
So that's what I mean by a degree of standardization with a facility-fit assessment. It’s a way to measure and reduce risk.”
All’s Better That Starts Earlier
Layth Ujam: “So let's draw to a bit of a conclusion. Tech transfer has had a boost this year, obviously making the best out of a bad situation. This COVID-19 pandemic highlights we indeed can accomplish things quicker, even smarter and better. We can be more productive. I’m hearing this sentiment from CDMOs and biopharma companies alike.
However, we still have serious sponsor-CDMO communication issues. We need to work on that. I quite like the use of ‘operational excellence’ to force us to be smarter.
I think we're in a relatively good place, but we can only improve. Obviously, the fact that we were getting all these drugs out year after year means something's working right.
I wouldn't, though, set a model on this – there is no ‘model tech transfer.’ What’s important is to look at each step of the process from as early on as possible, and then make sure we are fully prepared to proceed.
For that, the concept of ‘the earlier the better’ resonates. I quite like looking further into how a biopharma can work at their CDMO’s facility much earlier in the drug program. Taking on a feeling of “eradicating tech transfer” all together, now that's really interesting.”
Humble Editor: “So interesting that I’ve interviewed the leader of the tech-transfer eradication camp. It’ll follow our conversation. You won’t want to miss my candid discussion with provocateur Mark Witcher.”
EDITOR’S NOTE: Layth Ujam’s views are his own, and do not represent that of any of his previous or current employers. Our dialogue here is slightly edited and abridged for clarity and flow.
Be sure to look for our final editorial of this three-part series right here at Outsourced Pharma.