How the First 90 Days of a Fill/Finish CDMO Engagement Set the Tone for the Program

The first 90 days of a fill/finish CDMO engagement aren’t administrative onboarding. Patterns are established early on how both parties communicate in this period, how they handle the first unexpected problem, whether the CDMO shows up as a genuine partner or a service provider waiting to be told what to do.

What a Strong Kickoff Looks Like

A kickoff that goes well isn’t just an introductory call. It’s a working meeting that accomplishes specific things: both teams meet each other, roles get established, and the timeline gets laid out — including what the CDMO needs from the sponsor to hold it. Those dependencies matter. API availability, document review turnaround, supply chain status on the sponsor’s side — if these aren’t surfaced at kickoff, they can surface later as problems.

From the CDMO side, a cross-functional team should be in the room: project management, QA, QC, operations, and MSAT. Not every person needs to speak but having the full team present signals a commitment. It tells the sponsor the program has the organization’s attention from day one.

When kickoff can happen onsite, it should. There’s practical value beyond the relationship-building: sponsors get a facility tour, if they haven’t already, they can meet the operators and site managers who will actually run their product, and they pick up the kind of context that doesn’t come through on a video call. When onsite isn’t possible, that relationship-building has to be more deliberately constructed in the weeks that follow.

One thing that often gets skipped: the follow-up. Meeting minutes and a full contact list — names, roles, direct contact information for everyone on both sides — should go out after every kickoff. It sounds like a small thing, but it isn’t.

Most CDMO content focuses entirely on what the CDMO should be doing. That’s only half the picture. A fill/finish CDMO in the first 90 days is heavily dependent on the sponsor — and programs that run into early friction often do so because that dependency isn’t fully understood going in.

The most common friction points aren’t dramatic. They’re slow document review. Delays in getting documentation to the CDMO. Unclear internal channels, especially around API decisions and testing requirements. In larger organizations, it may not be obvious who owns what decision or who has to sign off before something can move. A sponsor who hasn’t sorted out their own internal approval chain before kickoff will figure it out the hard way.

If a sponsor has a prior batch record or bench-scale documentation from a previous CDMO or development lab, getting that to the fill/finish CDMO early is one of the highest-value things they can do. It gives the CDMO a foundation that reflects the product’s actual history and not just its current specification.

Sponsor presence during engineering and pilot runs is worth more than most sponsors realize. The fill/finish CDMO is often encountering the product for the first time during pre-batch setup. Things come up.

HYPOTHETICAL

During a pilot formulation, a product becomes unexpectedly viscous during the addition of a certain excipient. A sponsor who is onsite can say immediately — “oh, that’s normal, we forgot to mention it” or “that’s strange, we’ve never seen that before.” Either answer is useful. Without the sponsor there, the process stops while someone makes a phone call. The CDMO is the expert on the process. The sponsor is the expert on the product. When both are in the room, problems get resolved in real time instead of over a series of calls.

One more thing worth considering: just as the CDMO brings a cross-functional team to kickoff, sponsors should think about whether their own coverage matches what the program requires. A three-person virtual biotech may need only one CMC or operational contact. A larger organization likely needs clear representation from supply chain, quality, and regulatory.

What a CDMO says at kickoff about responsiveness and communication isn’t the signal, but what they do in the weeks after kickoff is.

The clearest indicator that a program is being actively managed is contact between scheduled calls. Not the call itself — the things that happen in between. A project manager who sends a note because vials are on order and the ETA just came in, or because the pilot formulation wrapped and they’re on track — that’s the program being worked on, not just reported on. It tells the sponsor something without them having to ask.

It goes the other direction too. Questions between calls — a project manager reaching out to clarify a testing requirement or ask about a previous batch — are just as much a signal as updates. Active engagement looks like both.

If the sponsor only hears from the CDMO during scheduled calls, and those calls don’t show much movement, that pattern should be addressed directly rather than waiting to see if it improves. It usually doesn’t improve on its own.

Communication cadence should be figured out at kickoff. A program filling twice a year has different needs than one in active development. What matters is that it’s agreed on, not inherited from whatever the CDMO does by default.

Something unexpected will come up. It always does. A process behavior that wasn’t anticipated at bench scale, a supply chain dependency, a documentation gap that only becomes visible once it’s needed. The nature of it varies. What doesn’t vary is whether the CDMO and sponsor handle it well together.

What handling it well actually looks like: the CDMO loops in the sponsor immediately — not after they’ve fully worked through it internally, not at the next scheduled call — and they come to that conversation with something more than just a problem report. Ideas about what might be causing it. Options for how to address it.

A CDMO that goes quiet when something goes wrong, or that surfaces problems without any proposed path forward, is showing the sponsor something important. Early behavior is predictive.

The sponsor’s posture matters here too. Approaching a problem as something to solve together, rather than something to assign blame for, is part of what makes the collaboration function. Both parties need to show up that way.

The handoff from business development to project management is a known friction point. When the project manager only comes on after the contract is signed, kickoff becomes a reset. The sponsor has to re-establish context with someone new, and whatever trust was built during the proposal process doesn’t automatically carry over. A model where the PM is involved before contract signature avoids that reset — kickoff continues a relationship rather than starting one.

What good project management looks like in the first few weeks isn’t complicated: proactive communication between scheduled touchpoints, active management of open items without waiting for the sponsor to follow up, and genuine familiarity with the program. Not just familiarity with the contract — with the actual product, its history, and what the sponsor cares about.

The number of programs a project manager is carrying at any given time matters. A PM managing a large portfolio operates differently from one managing a smaller one, and that difference shows up in responsiveness and attention. It’s a reasonable thing for a sponsor to ask about directly.

Escalation paths need to be clear from the start. Who does the sponsor call when something needs a decision that’s outside the project manager’s scope? What’s the expected response time? Quality agreements document these commitments formally — escalation expectations aren’t just a matter of relationship, they’re defined. A CDMO with a mature escalation model will be able to answer these questions specifically at kickoff.

By 90 days, a sponsor should have a clear sense of whether the engagement is working. Did the CDMO communicate between calls without being prompted? When something unexpected came up, did they surface it quickly and come with ideas? Do the sponsor’s contacts know the program, or does every conversation feel like starting from scratch?

There are also specific things a sponsor should simply know by this point: who their contacts are across functions and how to reach them directly, where things stand in pre-batch setup, what the current timeline looks like and what’s in play. None of that should feel uncertain at 90 days.

If the sponsor is pulling information rather than receiving it, or feels like they don’t quite know who to call when something comes up — the right move is a direct conversation. The sponsor should initiate it. It doesn’t need to be confrontational: here are the expectations that aren’t being met, here’s what needs to change. Early enough in the program, there’s room to reset.

90 days is a useful point to pause and assess. If something feels off at week four, the conversation should happen at week four. The value of naming 90 days as a milestone is giving both parties a deliberate moment to take stock of how the engagement is actually going — not just how busy everyone has been.

The patterns established in the first 90 days tend to hold. So does the opportunity to change them, if the conversation happens early enough.

Afton Scientific is a U.S.-based sterile injectable CDMO specializing in aseptic fill/finish, supporting programs from Phase 1 through ongoing commercial manufacturing. To learn more, visit aftonscientific.com.