Tech transfer is a challenge, but reading about it doesn’t have to be.
First, we’ll start with an overview of tech transfer: what it is and why it matters. We’ll then define it in the context of baking cookies (just watch how far we can run with that).
Finally, we’ll consider the top needs and challenges faced by pharmaceutical manufacturers when it comes to transferring their technologies across stages, teams, and sites.
Technology transfer, or tech transfer, includes everything that’s needed to move a technical process from one organization to another.
For a successful tech transfer, all the steps and knowledge needed to understand and replicate every step along the way must be communicated.
Let’s say I know how to bake the world’s best chocolate chip cookie (I don’t, but a girl can dream). In order for me to complete a tech transfer of this procedure to your kitchen, I’d need to provide in-depth documentation on every step of the process.
So, what does that entail? The recipe, of course. But that’s just the start.
I’d also need to document the exact materials I used and their exact quantity, all of my cooking equipment, and my analytical methodology for taste testing the results.
There's also the subjective matter of deducing what exactly constitutes the world’s best chocolate chip cookie (in my humble opinion, Levain Bakery figured it out 25 years ago).
The measure of success for this tech transfer? If you’d be able to take all this information and replicate it to make a similarly perfect cookie: not in my kitchen (the source), but in your own home (the destination).
Your cookie would need to have an identical taste, texture, consistency, shape, and size as mine for our tech transfer to be considered a success.
Even for cookies, tech transfer is no mean feat (or we’d all be eating the world’s best chocolate chip cookie whenever we felt like it).
Every variable, from the altitude of my kitchen to the height of my oven rack, the humidity of the air and the expiration dates of every ingredient, would need to be tracked and accounted for.
As life science consultant Thomas Chattaway explains, “It is not a physical asset that is being relocated or duplicated, but an ability — something much harder to define, specify, and get right.”
But let’s say that somehow, against all odds, everything got transferred over perfectly. That still doesn’t mean the tech transfer will be a success.
What if you have a different palate than me? What if you prefer dark chocolate chips to milk chocolate? These differences in mindset can be unavoidable and even invisible, originating as they do from our subconscious biases and preferences.
Now that’s just cookies. Let’s take it a step further. What about logging and transferring all the countless steps and precise knowledge needed to bring a new drug to market?
In the pharmaceutical realm, the level of detail needed for tech transfer is at a whole other level. And with errors making the difference between healing and hazardous medicines, the stakes are much, much higher. That’s why it’s so difficult to achieve, and so crucial to get right.
In the pharmaceutical industry, tech transfer refers to any point at which the information needed to produce a drug must be communicated from one organization to another.
Let’s start with the tech transfer that’s needed between the different stages of drug development.
There are three main stages to the drug production lifecycle: preclinical, clinical, and commercial.
At the preclinical stage, scientists must take a newly discovered molecule and figure out how to turn it into a safe medicine. To do this, they need to constantly experiment with processes to determine which ones work best.
At the clinical stage, scientists must take the process determined in the preclinical stage and figure out how to make it repeatable at scale. They also need to account for higher safety standards so that the drug is deemed safe not only for animal trials, but human trials as well.
At the commercial stage, it’s all about volume. Manufacturers need to figure out how to consistently make a high-yield, high-quality batch as frequently and quickly as possible.
Let’s take a look at some of the most crucial tech transfer points between these stages:
Tech transfers ensure that crucial knowledge and data are retained throughout a drug’s discovery through its commercial release.
Tech transfer is needed at multiple points along the drug production lifecycle. Any time there’s a change to the site, team, manufacturer, or development stage, the entire process must be cataloged and transferred over.
Each of these transfer points comes with its own set of requirements and obstacles, but all of them share a need for documented equipment, materials, methodology, and quality standards:
Tech transfers include a mix of documents, procedures, product information, equipment specs, safety and stability data, training requirements, and analytical methods. The lump sum of all this data is often referred to as a tech transfer package.
Tech transfer can occur from one facility to another, between sites, when outsourcing to a contract development and manufacturing company (CDMO), or when bringing outsourced data back in house.
In pharmaceutical manufacturing, outsourcing can occur for a variety of reasons.
These include lacking the needed GMP infrastructure for clinical manufacturing, facing limitations in manufacturing capacity or equipment, or simply deciding to invest resources in other areas like drug discovery.
Tech transfer isn’t something that can be rushed. It takes attention to detail, analytical rigor, and proactive communication. And with the intricacies involved in pharmaceutical tech transfer, miscommunications are bound to occur, and bound to wreak havoc when they do.
But that doesn’t mean there aren’t ways to make it easier.
Increasingly, more pharmaceutical companies are turning to digital solutions to streamline the tech transfer that’s needed to and from their sites.
“Tech transfer isn’t just taking something, picking it up, and moving it. You’re also transferring all the knowledge needed to make it all happen. Every step, every motion: the full experience.”
— Anastasia Wengrowski, VP of Strategy, Apprentice
In a post-COVID world, digitization is no longer optional. 93% of manufacturing and supply chain professionals plan to focus on the resilience of their supply chain, with 90% planning to invest in talent for digitization.
Digitizing data capture and transfer lets the technology do the heavy lifting instead of the manufacturer. Instead of manually transcribing and sharing every component of their research, they can leverage digital records to record and store all their documentation in real time.
To stay competitive, drug manufacturers must think of every replication that’s needed along each stage of the drug’s lifecycle, not just their own. They must prioritize the transparency, accessibility, and reproducibility of their data.
Tech transfer isn’t just a process: it’s a mindset.