July 7, 2026
Content
A Scientific Leadership Perspective
Where Scientific Expertise Meets Client Experience
Structured CMC Collaboration, Built Around Your Program
In biopharmaceutical development, nearly every CDMO claims to be a partner. But when programs are complex and timelines are under pressure, the distinction between a service provider and a true partner becomes clear quickly. It shows up in how a CDMO responds when a program hits an unexpected technical hurdle, how proactively they communicate when timelines are pressured, and whether they arrive at those conversations with actionable solutions. At ProBioGen, this kind of support is how every program is managed, from the first technical discussion to final delivery.
This commitment to solution-oriented partnership is crucial to every program's success and is carried through every layer of program support, with scientific leadership playing a key role. We spoke with Dr. Volker Sandig, Chief Scientific Officer at ProBioGen, about where the most consequential program decisions are made, and what it takes to get them right.
A Scientific Leadership Perspective
At what point in a program do the most consequential decisions get made? And how does ProBioGen's scientific team ensure clients understand the downstream implications of those early choices?
Earlier than many clients or development teams expect. Early CMC decisions, from selecting the expression system to choosing the lead clone, shape the entire development strategy and have lasting implications for the scalability, productivity, and quality of a biologic. Our role is to take a holistic, systems-based view of a program and anticipate downstream consequences from the start. By doing so, we help clients make informed decisions based on all aspects of the development and manufacturing pipeline, so that their molecule is developed with manufacturability, robustness, and regulatory readiness in mind from the outset.
Where do you see the biggest gap between what clients expect from a CDMO scientifically and what they actually need, and how do you close that gap?
One of the biggest gaps is that clients often expect a CDMO to focus primarily on execution, when what they actually need is early scientific alignment on how development decisions will shape the program end-to-end. We close that gap by getting involved early as scientific partners, guiding them to what their choices mean for things like product quality, scalability, and regulatory path so they can make more informed decisions upfront.
"We help clients make informed decisions based on all aspects of the development and manufacturing pipeline, so that their molecule is developed with manufacturability, robustness, and regulatory readiness in mind from the outset."
Dr. Volker Sandig
Chief Scientific Officer | ProBioGen
Where Scientific Expertise Meets Client Experience
Translating that scientific expertise into a seamless client experience is where ProBioGen's project management team excels. We spoke with Stefan Iarusso, Director of the Project Management Office, and My Vu, a CMC Project Leader, who work at the intersection of CMC operations, science, and client relationships, to get their perspective on what solution-oriented partnership looks like in practice.
How does ProBioGen approach customer support differently than a traditional CDMO?
At ProBioGen, the project manager is not a coordinator sitting between departments. They are the person who understands both the science and the program context, and who takes ownership of keeping both aligned throughout the entire program.
That ownership is active, not administrative. We don't wait for a client to ask what is happening. We flag issues early, come up with solutions rather than just information, and make sure clients have what they need to make decisions quickly. Clients don’t just receive updates, we provide them with context, options, and clear recommendations. That clarity extends to how program scope and structure are defined from the start.
Structured CMC Collaboration, Built Around Your Project
Clients often seek clarity, flexibility, and predictability when selecting a CDMO partner. Different programs require different CMC approaches. Stage, timeline, internal capabilities, and strategic priorities all shape what the right path looks like. Based on client feedback, we developed a framework to provide adaptable solutions that meet them wherever they are in their journey.
CMC Navigator™ is ProBioGen's structured framework for protein CMC collaboration, developed based on client feedback to help teams align strategy, timelines, budgets, and execution with their current program priorities. Four service models — Sprint, Scale, Customize, and Rise — each address a specific program situation, so scope and path forward are clear from the start.
Can you walk us through an example where a client came to you with a complex challenge? How did your team navigate it?
A typical example is a client approaching us with an accelerated timeline and a process that, on the surface, looks workable, but carries real scalability risks, especially for complex, non-standard molecules.
In one case, we identified that the process development would not translate reliably in a short time from small scale to GMP manufacturing. Instead of progressing and accepting the risk, we mobilized quickly across USP, DSP, and analytics within a very short timeframe, and proposed a structured mitigation strategy.
This included targeted scale-down experiments, parallel data generation, and a clear decision framework for the client.
The client had a clear picture of the risk, a concrete path forward, and enough information to make the call themselves. The program kept moving.
How do you keep clients informed and confident throughout a project, especially when things don't go exactly to plan?
Transparency and proactive communication are critical, especially when a program is under pressure.
We work to establish clear governance early in each program, including regular touchpoints, decision trackers, and defined escalation paths, so that when deviations occur, there is already a shared process in place to handle them. We communicate early, explain the impact in practical terms, and always come up with a proposal on how to move forward.
"Confidence does not come from avoiding issues, but from how consistently and clearly they are managed."
Stefan Iarusso
Director, Project Management Office | ProBioGen
Clients know where we stand, what the implications are, and what we recommend next. That creates trust, even in challenging phases.
What kind of feedback do you hear from clients at the end of a program — and what does that tell you about how ProBioGen's support lands in practice?
The most consistent feedback is that clients feel in control of their program, even when navigating complex situations.
They highlight the clarity of communication, the structured way decisions are prepared, and the fact that they are not left alone with uncertainties.
Clients also tell us that we do not overpromise. We set realistic expectations from the start and then deliver against them. And in an industry where timelines and outcomes are under constant pressure, that consistency matters.
This feedback tells us something important: good project management shows up as reliability and confidence throughout the collaboration, not just in the final delivery.
For a client considering ProBioGen for the first time, what sets the working relationship apart from day one?
The first thing clients notice is that we spend real time on alignment before anything else. Understanding the program in detail, stress-testing the timeline, agreeing on how decisions will be made. That upfront investment changes how the rest of the project runs.
Communication is proactive and structured from the start. Questions get answered before they are asked, and issues get raised before they become urgent. Clients don't need to coordinate across functions or chase answers internally; that's our job.
What we want every new client to feel from that first conversation is that their molecule is in the hands of a team that is as invested in its success as they are.
Talk to Our Team
Partnership in biopharma development is tested in the moments that don't go to plan, in how quickly a CDMO surfaces a problem, and how clearly they help a client navigate it. That standard shows up consistently here, reflected both in client retention and in the satisfaction scores clients report back. The work speaks for itself, but so do the clients who keep choosing to come back. If you are evaluating options for your program, get in touch with the ProBioGen team.