Tech Transfer 2025 – A High-Stakes Game Of Trust

By Louis Garguilo, Chief Editor, Outsourced Pharma

I was gently reminded I hadn’t circled back to the subject of tech transfer in a while.

My oversight, herein corrected.

The exchange of emerging or expanding programs from drug sponsor to CDMO, and any process and product knowledge earlier attained, demands a continuously renewed attention.

Even as newer modalities mature, and industry playbooks become more widely dispersed, today’s sponsors still wrestle with this fundamental question:

How do we ensure a CDMO understands and then executes on our desires and processes with alacrity and without costly misconceptions – and sans a whole lot of stress?

And on the side of the receivers:                                                              

How do we translate what are – despite a sponsor’s best efforts perhaps – often incomplete data packages and overly optimistic goals, into a smooth development and production ramp-up … and do it under pressure from clients who are often budget and time constrained?

For sponsors and CDMOs, tech transfers present moments of vulnerability.

You Are Transfering Trust

Often, years of r&d, and accumulated knowledge and nuanced scientific and technical understanding – often held by a small team at a biotech – must now be magically externalized, and entrusted to a partner to be a magician.

Changing metaphors, especially for those smaller biotechs with limited manufacturing experience, this moment can feel like bungee jumping.

And so you make decisions along these lines. 

Do we want our CDMO to “own the project” from the transfer, and operate with a great deal of independence?

Or do we insist on close supervision and a stricter control over how projects are transferred and initiated (and then fully executed)?

Perhaps you may fall somewhere in between, but no matter your stance, it should be driven by your outsourcing and operational strategies. 

Practically speaking, have you worked with the CDMO before and made an earlier determination of "trustworthy" as well as on the CDMO having the skills and capabilities?

Your answer to that impacts how you and your CDMO view the transfer well before the act.

This also needs to be reckoned with:

Because of the necessity for the (sometimes assumed) need for speed and other factors (think funding), do you have the CDMO drinking data from a firehose? Staying on that line of thought, is your CDMO actually allowed to digest the transfer?

From the CDMOs' perspective, it often inherits a patchwork of documentation and untested process assumptions. 

They are asked to operate on those assumptions in a new facility with different equipment and configurations while adhering to quality and regulatory standards.

So on both sides – the sender and receiver of development and manufacturing programs – the tech transfer is also a trust transfer.

What's Success Look Like

Success, defined.

A program transfer to a CDMO resulting in a timely start on the correct glide path.

For that short statement to be realized you'll need room for some experimentation to assure acceptable reproducibility with consistent quality and regulatory adherences; a degree of flexibility built into timelines and (yes) budgets; few(er) surprises, but should anomalies arise, quick mutual recognition and remediation.

Stuff happens. Materials don’t behave as advertised. Scale ups take on new impurities. Preferred development routes hit detours. How these events are handled is highly determined by how you set your working relationship with the CDMO at the initial transfer and implementation.

Success, then, can, but does not insist on flawless processes or products at all steps and stages.

Go back to our above statement of success.

• "Timely" can imply moving forward and performing "the correct activities at the right time and as necessary."
• Of ultimate importance is "setting and starting out on the correct and agreed upon glide path."

Trust plays a role. It's needed when decisions affecting both time and path must be made. 

Revisiting the topic of tech transfer reminds us that along with the technologies, templates, and timelines, we're also managing a critical decision-making partnership.

CDMOs Under Pressure

CDMOs today are often asked to absorb “program risks,” such as milestones and new equipment costs, and to practice flexible and reactive scheduling.

Unfortunately, these contract and operational asks by clients force CDMOs to cast a more jaundiced eye on who they actually want to onboard as customers.

Sponsors should thus be cautioned. Your early discussions themselves can become a filtering factor for the CDMO.

Likewise, as hinted above, if a biotech is unprepared – lacking clear objectives or internal alignment, process descriptions, scale-up strategy or related goals, or perhaps not-so-logical critical quality attributes (CQAs) — a CDMO may hit the relationship pause button.

Experienced CDMOs may have "tech-transfer-intake evaluations" to assess transferability and client compatibility before any work begins.

Some CDMOs now offer pre-transfer readiness audits, or “Phase 0” collaboration frameworks, to proactively align on expectations before the official transfer process kicks off.

Don't attribute this heightened selectivity to CDMOs becoming more difficult to work with.

Rather, it’s a rational adaptation to increasing sponsor expectations, the complexity of today's programs, and more virtual start-ups entering the field of drug development. 

The best tech transfers, then, are both based on structures and strictures, but at the same time exercises to determine culture and compatibility, and either gain or renew a working trust. 

For CDMOs, desirable sponsors bring documentation, and if possible people: scientists who have worked with the program, quality or analytical leads, and consultants. They take the time for on-site (or virtual) visits, engage in open dialogue about what’s known vs. assumed.

In return, your CDMO should be assessable, and assign stable transfer and project teams, and communicate clearly. Onboarding should be  bidirectional.

Mark down the tech transfer as the crucial moment your project and your partnership begins.