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The Golden Goose of Biologics: Collaboration with Your CDMO
- Sarah Sink
- 58 minutes ago
- 3 min read
Protein-based biologics are powerful, precise, and full of potential. They can treat diseases that small molecules never could. But they also come with a catch: they don’t always behave.
Ask anyone who has taken a biologic from the lab to manufacturing, and you’ll hear the same story. The molecule looks beautiful on paper until it faces the stress of scale-up. Then the protein starts to misbehave, aggregating, unfolding, or reacting in ways that no one expected.
Formulation and stability aren’t just technical hurdles. They are turning points that determine whether your molecule moves forward smoothly or becomes stuck in a costly loop of investigation and rework.
The Personality Problem
Proteins are complex structures, and they don’t like change. A buffer adjustment that seems minor can shift pH enough to alter structure. A different pump speed or filter can introduce shear stress that triggers aggregation. Even the choice of container closure, whether glass, rubber, or plastic, can affect adsorption and stability.
These are the reasons biologics require so much care at every stage. And while the science is intricate, the solution is simple: bring in your subject matter experts early and often.
Your analytical, formulation, and process SMEs should not just review data. They should shape how that data is interpreted, transferred, and applied across each phase of development. Too often, companies wait until after signing with a CDMO to engage them in critical conversations about analytical comparability, fill-finish compatibility, or storage conditions. By that point, some risks are already built into the plan.
The Power of Collaborative CDMOs
The best CDMOs don’t just manufacture. They collaborate. They ask tough questions, bring their own SMEs to the table, and challenge assumptions in the name of protecting the molecule.
That is the golden goose: finding a partner who values collaboration over convenience.
A CDMO can take the molecule and run with it when processes are well-defined, but during tech transfer, close coordination is everything. Tech transfer is where theoretical stability meets real-world execution. If the teams are not communicating, that is where timelines fall apart.
When CDMOs and biotech sponsors work shoulder to shoulder, share data, test assumptions, and adjust in real time, they prevent issues that no single team could catch alone.
Where Programs Lose Momentum
Programs often stall not because the science is wrong but because communication slows. Analytical teams validate one set of conditions while manufacturing operates under another. Protocols shift slightly during transfer. Specifications are interpreted differently between facilities.
Each of those small gaps creates friction. In biologics, friction shows up fast as aggregation, yield loss, or unexpected stability failures.
When SMEs are engaged throughout, they catch those nuances. They know which parameters truly matter and can adjust quickly when something doesn’t translate from small-scale to GMP.
BD’s Role: Building the Bridge
Business development professionals play a crucial role in this process. We are the bridge between biotech strategy and CDMO execution. Our job is not just to align on cost and capacity; it is to ensure that collaboration is built into the partnership from the start.
When evaluating CDMOs, biotech teams should ask questions that reveal how the organization engages its experts:
Will our formulation and analytical SMEs have direct access to yours during tech transfer?
How do you manage real-time communication when an unexpected result occurs?
What level of transparency do you provide during manufacturing and data review?
These questions do more than signal partnership expectations. They help you find the CDMO that sees your molecule as a shared mission rather than a deliverable.
Final Thoughts
Protein-based biologics will always come with a few surprises. But programs that plan for them by engaging SMEs early, maintaining open communication, and partnering with collaborative CDMOs are the ones that stay on track.
Before you sign with a CDMO, make sure you know what kind of partner you are choosing. The golden goose is not the team that promises smooth sailing. It is the one that invites you into the cockpit.
If your biotech team is preparing to scale up a biologic or transfer methods into GMP, check out my guide, How to Compare CDMO Quotes: 10 Factors Beyond Cost. It walks you through how to interpret proposals, identify collaboration-minded CDMOs, and choose partners who will help you execute with confidence.
In biologics, success does not depend only on the science. It depends on the partnership behind it.
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.