Completing a successful tech transfer
In the complex world of pharmaceutical manufacturing, pharma tech transfers – the process of moving manufacturing operations between facilities or phases – can present significant challenges.
A recent pharmaphorum podcast, sponsored by and featuring experts from Lannett CDMO (who recently published an eBook on the subject), shed light on the intricacies of this process and offered valuable insights into best practices.
You’ve seen one pharma tech transfer… you’ve seen one
Grant Brock, VP of operations, and Frantz Maignan, director of validation and tech services at Lannett, spoke about the tech transfer process as a single process, but Maignan emphasised up front that there’s a great deal of variation from one pharmaceutical technology transfer to another.
“It could be something that's at bench scale, still very small and experimental, to very large commercial scale, where you're transferring it from one large manufacturing facility to another,” he said. “There are a whole bunch of reasons why people do that, too. Sometimes it's a more favourable cost structure. Sometimes it's maybe more flexibility and scheduling. Or you may even have a site that has quality issues, so they want to go somewhere that has a better quality profile.”
That variation also means that technology transfer challenges in execution are always different. But there are some commonalities.
"Sometimes, when you're starting to look at the project, you have the use of novel technologies or ingredients,” Maignan said. “Sometimes, your analytical testing methods can be pretty complex and they're very difficult to transfer." He also pointed out that high-potency compounds and unforeseen equipment failures can complicate the process.
Time sensitivity is a crucial factor in tech transfers, Brock added.
"There are financial expectations and results that are dependent upon the schedules of bringing a product to the market or transferring a product into a new CMO,” he said. “So it's very critical to their business and their success."
“Sometimes, if you are doing a tech transfer and things start to delay and run behind, it has a sort of a ripple effect, if you will, in scheduling all kinds of other items that are going through the facility,” Maignan added.
Best practices for successful technology transfer
To navigate these challenges, the experts offered several best practices. Maignan stressed the importance of avoiding assumptions.
"Those can always come back and haunt you,” he said. “A good case in point is assuming that maybe a product's characteristics or performance won't change when you change scale. They can."
He also emphasised the need for realistic expectations and frank discussions with clients, rather than overpromising and underdelivering.
Experts also discussed strategies for maximising cost efficiency. Maignan suggested "designing and scheduling experiments […] to maximise the amount of knowledge you gain and minimise the amount of material consumed.” That can mean figuring out which processes have to be done one at a time and which can run in parallel.
Additionally, Brock pointed to the importance of asking clients the right questions up front.
“For example, have they done any studies on powder flow characteristics?” he said. “Have they looked at particle size ranges within each excipient or key ingredient and how that could potentially impact, either positively or negatively, the transfer? Making sure those questions are asked and answered is very helpful in making sure that you can remain cost effective.”
Why planning is paramount
Once a CDMO has asked the right questions and understands the manufacturing process, they can design the right tech transfer procedures. Having a solid technology transfer plan means being prepared, but it also means being realistic about how long a tech transfer process will take and communicating that with all sides of the business at a pharma or biotech company.
"There's always this friction between the commercial objectives and the project timing and planning," Brock says. "Once an organisation decides they're going to move a project forward and fund a particular product and bring it to market, the expectation is that it should have happened yesterday. We approved it. Why don't we have it yet?"
The job of a good pharma tech transfer partner is to moderate those expectations, but also to make sure that if a goal is achievable, they do what they need to do to achieve it.
"If there's a totally unrealistic expectation, we need to be transparent and clear about that," Brock said. "But we also need to say, hey, here are some opportunities to meet your objectives, but maybe it requires additional resources. Maybe it requires doing something a little outside the box in order to get it done in a reasonable timeline that meets their objectives."
Choosing a CDMO development partner
For companies in the pharmaceutical industry selecting a CDMO partner, Maignan recommended looking for "a history of successful tech transfers" and a history of regulatory compliance and passed inspections. Every company will proclaim itself best in class, Brock added, but the proof is in a history of successful executions.
Ultimately, Brock says, a good partner is communicative and accountable.
“Every tech transfer will have its own set of circumstances and hurdles that have to be overcome. It's how the team responds to those challenges that really makes the difference in the experience that the customer has,” he said. “Because the last thing a customer wants to hear is ‘Your project's not going to happen because of this, but by the way, we didn't tell you about that issue three months ago when we knew about it. We're telling you now, after it’s too late and we can't do anything to change the outcome’.”
If pharma companies choose the right partner, Maignan advised, they’ll be able to sidestep some of the common pitfalls of tech transfers.
“If you have a solid project plan and realistic timelines and milestones, you're going to be successful,” he concluded. “You're going to hit it on time and on budget.”
You can listen to the full podcast, with more insights into tech transfer success, here.
