Modern Tech Transfer: The Expectations That Make or Break Biologic Programs

Sarah Sink
Dec 11, 2025
3 min read

Tech transfer in biologics has changed. It is no longer a handoff. It is no longer a binder full of documentation. It is no longer something that “happens” once development is complete.

Modern tech transfer is a real partnership, and expectations are higher than ever. Biotech teams want clarity, consistency, and confidence that their molecule will behave the same way in GMP that it did in development. CDMOs want context, rationale, and engagement so they can run the process reliably the first time.

When expectations are clear, tech transfer moves forward with momentum. When expectations are unclear, programs stall, teams become frustrated, and timelines take the hit.

So what should biotech companies and business development professionals expect from a modern tech transfer process, and what does it take to do it well?

Expectation 1: Shared Understanding, Not Just Shared Documents

The old model of “send the package and hope for the best” is gone. Modern tech transfer requires shared understanding of the process, not just shared information.

Biotechs should expect their CDMO to ask thoughtful questions, challenge assumptions, and want to understand why each parameter matters. And CDMOs should expect biotechs to explain not just what the process is, but what the molecule has taught them along the way.

Programs break down when knowledge stays locked inside one team instead of flowing between both sides.

Expectation 2: SME Access from Day One

Today, SME involvement is not optional. It is the foundation of a successful transfer.

Biotech teams expect direct access to analytical, formulation, and process SMEs who can interpret data quickly and discuss risks without waiting for multiple layers of internal communication. CDMOs expect biotech SMEs to be available to clarify the details that documentation alone cannot convey.

When SMEs are not involved early, misalignment builds quietly. When they collaborate early, issues get solved before they ever become delays.

Expectation 3: Transparency When the Molecule Misbehaves

Biologics rarely transfer perfectly. Proteins react to changes in scale, mixing, or equipment. Assays may behave differently in a new lab.

Modern tech transfer expects honesty. It requires both sides to acknowledge when something shifts, when a parameter needs adjustment, or when the molecule behaves unexpectedly.

There is nothing more damaging than silence during a biologic tech transfer.

Transparency creates trust, and trust keeps programs moving forward.

Expectation 4: Communication That Is Proactive, Not Reactive

Modern tech transfer moves too quickly for reactive communication. Biotechs expect regular updates, visibility into decisions, and early notification when something needs attention. CDMOs expect engaged sponsors who respond quickly and appreciate the realities of GMP execution.

Consistent, proactive communication prevents surprises.

Surprises are what break programs.

Expectation 5: Realistic Timelines and Clear Responsibilities

Timelines fall apart when expectations do not match reality. Today, both sides need clarity on:

Who owns each task
What information is still needed
When critical decisions must be made
What risks could impact scheduling

Biotech sponsors should expect CDMOs to define realistic timelines based on true capacity. CDMOs should expect biotech teams to supply complete and accurate information without delays.

When responsibilities are clear, timelines hold. When they are vague, programs drift.

Expectation 6: A Partnership Mindset, Not a Transaction

This is the expectation that defines everything else.

Biotechs should expect their CDMO to treat the molecule as a shared responsibility. CDMOs should expect biotechs to be collaborative partners, not distant observers.

Modern tech transfer succeeds when both teams work with one goal in mind: move the molecule forward with quality, clarity, and confidence.

Final Thoughts

Modern tech transfer is a partnership. It is defined by expectations that must be clear from the very beginning and honored throughout execution. The biotechs and CDMOs that meet these expectations consistently achieve smoother transfers, better alignment, and faster progress toward the clinic and commercial scale.

If your team is preparing for a tech transfer or evaluating potential CDMOs, explore my guide, “How to Compare CDMO Quotes: 10 Factors Beyond Cost”, for a simple framework to assess collaboration, expertise, and communication fit. It can help you identify the partners who will meet these expectations and deliver with confidence.

Because in biologics, expectations are not just guidelines. They are what make or break programs.

For more insights and personalized support in navigating the biotech-CDMO landscape, visit www.yourpharmagirl.com and follow Your Pharma Girl on LinkedIn. Whether you need strategic guidance, tailored BD solutions, or expert advice on building lasting partnerships, I am here to help you and your team succeed at every stage of development.