Top 5 Reasons Tech Transfer Keeps Breaking… And What We Can Do About It

by Teodor Leahu | posted on May 19, 2025

In biologics, tech transfer isn’t a one-time event. It’s a recurring challenge across scales, sites, and often entire organizations. A single product might go through three or four transfers across its lifecycle: from process development to validation, then to clinical production, and eventually into commercial manufacturing.

These transitions are essential. But more often than not, they’re also painful.

Despite decades of innovation, tech transfer remains one of the slowest, most failure-prone stages in the product lifecycle. We keep trying to fix it with more documentation, more SOPs, more alignment meetings. But the problem isn’t effort. It’s architecture. Most life sciences teams still treat tech transfer as a handoff, when what we really need is co-authorship.

Why Internal Transfers Aren’t as Simple as They Seem

There’s a persistent belief that internal tech transfers—between departments or sites within the same organization—are simpler. Shared systems. Aligned teams. One big happy enterprise.

But here’s the reality: if the knowledge doesn’t flow, it doesn’t matter who owns the building.

I’ve worked on internal transfers where process development was on the first floor, and manufacturing was on the third. Still, we were out of sync. I’ve also worked on transfers across continents, and in many ways, the disconnects were the same.

Imagine the scenario – midway through a tech transfer to pilot scale for a clinical material campaign, your chromatography yield is below specification. The root cause: process development (PD) updated the UV collection values without informing manufacturing. The update to PD documentation never propagated. A simple misalignment that results in months of delay while compromising your ability to demonstrate manufacturing consistency.

Now, consider the same failure, specifically on the second of three consecutive validation batches. How does one data transfer oversight impact your regulatory timeline and commercial launch? 

It’s not about location. It’s about alignment. And alignment is hard to achieve when your process knowledge is fragmented, your communication is linear, and your collaboration lives in static documents.

The Hidden Pitfalls of Tech Transfer (and What They Really Look Like)

Many of the biggest breakdowns in tech transfer stem from familiar issues, but most organizations don’t see the full picture until something goes wrong. Below are the core pitfalls I’ve seen again and again… and why they persist.

1. Dispersed Knowledge

Let’s say your process development team has generated a series of reports, each with critical insights. One outlines unit operations, another defines setpoints, and a third details intermediate sampling. Individually, each is valuable. But none of them, on their own, tells the whole story.

In practice, that means the team receiving the tech transfer has to reverse-engineer the logic behind the process. Stitch together PDFs. Cross-reference slides. Hope nothing gets lost in translation.

And something always does.

We talk a lot about “process knowledge,” but too often that knowledge is scattered and nowhere near ready for handoff.

2. Incomplete Documentation

Even when the science is solid, the documentation often falls short. Why? Because process understanding doesn’t always get formalized. It stays in people’s heads or in unstructured formats spread across departments.

I’ve seen cases where critical parameters or sampling steps weren’t explicitly documented because someone assumed, “Well, everyone knows that.” But when that assumption crosses continents (or even just departments), it fails.

And then, a deviation.

Process definition and control strategy are rarely documented as one unified object. But they should be. Because in practice, they represent two halves of the same thing: process knowledge.

If you don’t know what you’re measuring, when, and why, you’re not ready to scale.

3. One-Way Communication

Traditional tech transfer assumes a unidirectional flow: development pushes, manufacturing receives.

That model breaks down quickly in real life.

When you’re scaling from small-scale development to CGMP manufacturing, adjustments are inevitable. Pumps, probes, mixing dynamics—all differ at large scale. But if feedback from the recipient never reaches the donor, the process is treated as locked. That’s a problem.

For example: I’ve seen a spec for a pH sensor set at ±0.05, only to find out that the inline sensor at commercial scale had a tolerance of ±0.1. That’s not a trivial mismatch. That’s a baked-in deviation.

Process development brings the science. Manufacturing brings the engineering. If those voices don’t meet early(and by early, I mean before specs are finalized), you’re setting yourself up for iterative failure.

4. Engineering Misalignment

Sometimes, a spec defined at development scale isn’t feasible at manufacturing scale. But instead of raising a red flag, the manufacturing team quietly adjusts it.

Maybe they round up a flow rate. Swap a pump. Modify a hold time. All of it well-intentioned, but all of it potentially process-breaking.

The development team never knows. Until they get a call about a failed lot.

This is where the idea of “first-time-right” tech transfer dies. Not because of poor science, but because the process was never calibrated for the real-world constraints of production.

The fix? Collaboration before execution. Not after failure.

5. Static, Siloed Formats

Most tech transfers are still run on PDFs, Word docs, Excel files, and disconnected systems. That means every stakeholder, from development to QC to the CDMO, gets a slightly different version of the truth.

I once worked on a tech transfer where the process development team shared a schematic of the filtration step. It made sense to them, but not to my technicians. We had to redraw the entire diagram, down to the valve instructions, just to make it operational.

And that’s assuming the documentation even includes material details. In one transfer, we couldn’t figure out why buffer conductivity was off until we discovered we were sourcing salt from different vendors. Nowhere in the master batch record did it mention the supplier name or catalog number. Just “NaCl.”

Bridging Science and Engineering with Shared Process Knowledge

At its core, successful tech transfer isn’t about documentation. It’s about shared understanding.

Process development contributes scientific knowledge on how and why a process works. Manufacturing contributes engineering knowledge, in other words, what’s actually feasible on real equipment.

Too often, those knowledge sets don’t meet until it’s too late. But when they do, and when they converge in a shared digital space, something powerful happens: you stop handing off documents, and you start co-authoring process execution.

That’s where orchestration comes in.

Orchestration: Turning Process Knowledge into a Shared Asset

Let me put it this way: if you give me the Mona Lisa and tell me to replicate it on a seven-meter-tall building, I can try. But unless you also give me the brushstrokes, the coordinates, and the color palette, I’m going to fail.

Tech transfer works the same way.

A PDF can’t give you execution logic. A version-controlled Word doc can’t notify you when the pH spec gets updated. A schematic in someone’s slide deck doesn’t tell you how it behaves in MES.

But a dynamic, executable workflow can.

When you orchestrate tech transfer through a shared, versioned workflow:

• Process definition and control strategy become one object.

   

• Scientific assumptions are visible and reviewable by engineering.
• Equipment constraints are flagged before deviations happen.
• And both sides—donor and recipient—co-own the outcome.

You stop running after deviations. You start designing for success.

Conclusion – What’s at Stake

When tech transfer fails, it’s not just a process problem; it’s a business problem. Delayed lots cost months. Missed specs cost credibility. And in competitive markets, even a small delay can mean losing first-mover advantage.

But it doesn’t have to be that way.

When process development and manufacturing teams align early, scientific logic on one side, engineering realities on the other, you create the conditions for first-time-right execution. And when that shared understanding lives in a unified digital workflow, it becomes repeatable, scalable, and future-proof.

You don’t need more documents. You need orchestration.

To learn more about our orchestration platform, L7|ESP®, visit the L7 website or contact us to start the conversation.