What Biotechs Miss in CDMO Proposals (And Why It Matters Later)

Sarah Sink
Dec 17, 2025
3 min read

CDMO proposals can look polished, thorough, and reassuring. Pages of timelines, capacity statements, and technical capability slides create the impression that everything is covered.

But for protein-based biologics, what is missing from a proposal is often more important than what is included.

Many biotech teams focus on cost, timelines, and whether the CDMO can technically execute the work. Fewer teams slow down to examine how the proposal reflects real execution risk across development, scale-up, tech transfer, and sterile fill and finish.

That gap is where programs stumble.

Proposals Tell You What Can Be Done, Not Always How It Will Be Done

Most CDMO proposals are built to confirm capability. They outline available equipment, headline experience, and high-level scope. What they rarely show is how that work will actually flow across functions and facilities.

For protein-based biologics, this matters early.

A proposal might confirm development experience, but not explain how process knowledge is preserved during tech transfer. It might describe fill-finish capacity, but not address how formulation decisions upstream affect container compatibility, filtration behavior, or aseptic risk downstream.

When those connections are not clearly articulated, biotech teams are left making assumptions. Assumptions are expensive in biologics.

The Development to Manufacturing Disconnect

One of the most common gaps in CDMO proposals is how development transitions into GMP execution.

Biotechs often assume that once development work is complete, manufacturing simply picks up where it left off. In reality, that handoff is one of the highest-risk moments in the program.

Questions that are often missing from proposals include:

How are development learnings documented and transferred to manufacturing teams?
Who owns analytical comparability when methods move from development to QC?
What happens if process parameters behave differently at GMP scale?

If a proposal does not address these points clearly, it is not a complete picture of execution readiness.

Sterile Fill and Finish Is Not a Footnote

Sterile fill and finish is often treated as a downstream checkbox. In proposals, it may appear as a short section with container types, batch sizes, and high-level timelines.

For biologics, that is not enough.

Fill-finish success depends heavily on decisions made much earlier in development. Protein concentration, viscosity, formulation composition, and filtration strategy all influence whether fill-finish runs smoothly or becomes a bottleneck.

A strong proposal should make it clear:

How formulation and process decisions are evaluated with fill-finish in mind
How development and fill-finish teams communicate during tech transfer
What contingencies exist if the product behaves differently during aseptic processing

When fill-finish is disconnected from development and manufacturing in a proposal, risk is being pushed downstream rather than managed upfront.

What Business Development Should Be Looking For

From a business development perspective, proposals are more than pricing tools. They are early indicators of how a CDMO thinks, communicates, and partners.

The strongest proposals reflect:

Cross-functional alignment between development, manufacturing, QC, and fill-finish
Clear ownership of risk, not just task execution
Willingness to engage SMEs early and throughout the program
Transparency about what is known, what is assumed, and what still needs to be learned

If a proposal feels overly generic or avoids addressing complexity, that is a signal worth paying attention to.

What Biotech Teams Should Ask Before Signing

Before selecting a CDMO, biotech teams should read proposals with execution in mind, not just feasibility.

Ask questions like:

How will knowledge move from development through sterile fill and finish?
Who is accountable when assumptions do not hold at scale?
How do teams communicate when analytical or process issues arise?
What does collaboration look like when timelines are under pressure?

The answers often matter more than the numbers on the page.

Final Thoughts

CDMO proposals are not just commercial documents. They are previews of how your program will be executed.

For protein-based biologics, success depends on how well development, manufacturing, tech transfer, and sterile fill and finish are connected. When proposals reflect those connections clearly, programs move with confidence.

When they do not, risk accumulates quietly until it surfaces at the worst possible moment.

If your team is comparing CDMO proposals, my guide, “How to Compare CDMO Quotes: 10 Factors Beyond Cost,” is designed to help you spot these gaps before they become problems. It walks through what to look for beyond pricing and timelines so you can select partners who are prepared to support execution from development through sterile fill and finish.

Because in biologics, the proposal is only the beginning. Execution is what determines success.

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 business development support, or expert insight into building strong CDMO partnerships, I am here to help you and your team succeed at every stage of development.