My CDMO Is A Constellation of Unified Skills. Is Yours?

By Louis Garguilo, Chief Editor, Outsourced Pharma

A CDMO employs accomplished professionals, operates modern facilities, and still frustrates the heck out of you.

Accumulated talent and capabilities are impressive, but closer examination reveals the problem lies between the lines of the CDMO’s work demarcations.

Key lessons from Development fail to reach Manufacturing, which discovers a constraint only after your process is locked in. Tech transfers feel like starting from scratch.

What you need from a CDMO is a constellation of unified skills.

Constellation meaning a holistic pattern of work that forms an interconnected organization, and presents a clear picture of management and culture.

The individual stars, if you will, are comprised of:

• business development/customer service professionals
• scientists/engineers, analytical, quality/regulatory experts
• senior and project managers
• materials/logistics/supply chain professionals

This individual expertise is fully utilized when internally coordinated to guide the work performed, engage the client, and carry a program from start to finish.

How does a CDMO get to this unification?

It begins with Executive Leadership; men and women paying close attention, ensuring the effective practice of “collaboration” is a companywide monitored corporate value.

All senior personnel have a role in actively supporting cross-functional operations, and encouraging employees to resolve problems across departmental boundaries.

There is a component here of hiring, as well, and a need for strategic recruitment and retention strategies.

CDMOs need PhD-level biochemists, experienced process engineers, and regulatory veterans serving as astute collaborators across functions, and outwards to sponsor teams. Experienced employees can help colleagues develop the habits of continuous improvement, constructive problem-solving, and knowledge sharing.

Look around your CDMO:

Can you identify the professionals who foster those behaviors? Those employees who fulfill individual responsibilities by adequately understanding, guiding, and effectively communicating with you?

The CDMO constellation requires enforced systems for sharing information, documenting decisions, tracking issues, and maintaining program visibility. Without such connections, even the best people and facilities will frustrate sponsors, and produce a poor outsourcing experience.

Relationships and Creative Problem-Solving

Call it interpersonal, relational or what have you, but this idea of a coherent constellation requires an ability to build genuine relationships precipitating creative problem-solving.

You want your CDMO to internalize your scientific vision, commercial objectives, development constraints and opportunities, and culture.

And as part of this constellation, you need to reciprocate.

On both sides – throughout the organizations – there are also sensitivities to concerns that may not be explicitly stated. A CDMO that listens carefully can address the underlying concern rather than simply answer the immediate question.

However, your questions about a specialized analytical method, for example, may reflect difficulties encountered with a previous partner. Obviously, the best way forward is if you volunteer those details to your partner.

Consider a smaller biotech approaching its CDMO with an unconventional formulation that does not fit standard unit operations.

An integrated CDMO brings the relevant development scientists, process engineers, analytical experts, quality representatives, and supply chain specialists together to explore the options – with you.

The outcome might be an adapted process, a revised control strategy, or a clear explanation of why the proposed approach will not work.

The point is not that a CDMO should always find a way to say yes, but that answers emerge from coordinated expertise and not a succession of disconnected objections.

Consider now the demands of cell and gene therapies. Programs may require specialized expertise in viral vector production, cell processing, analytical methods for identity and potency, and aseptic fill-finish operations. They depend on reliable supplies of specialized starting materials, plasmids, viral vectors, and critical inputs from regulatory and other professionals to support development and manufacturing decisions.

The practical (scientific) challenges and the human coordination required to work through these relationships are both important.

The Connecting Force Of Project Management

We are (theoretically at least) set up as an outsourcing universe unified and visible via project management.

Effective PMs translate objectives into workable plans, align multidisciplinary teams around milestones, and protect timelines and budgets from delays and scope changes.

They connect the activities of process development, analytical development, quality, supply chain, and regulatory affairs, making sure dependencies and potential conflicts are visible before they become costly problems.

The strongest project managers are also people managers. They bring the right people into the technical discussion, resolve issues between working disciplines should they arise (because leadership has imbued them with the authority to do so), but also escalate issues when required.  

Still, for all that expected of a CDMO’s project manager, from your perspective as  the sponsor, you want to know the PM is representing and fully informing you on discussions, and challenges and opportunities.

Thank Your Lucky Stars

Engaging a CDMO whose skills and functions work in concert can bring substantial benefits.

• Timelines become more predictable as cross-functional visibility helps identify risks earlier
• Costs are better controlled when decisions account for implications across development, manufacturing, and supporting functions
• Quality practices and outcomes benefit from operational discipline and shared lessons learned

Overall, you gain greater confidence in your partner, who in turn, encourages a more open and collaborative relationship.

Today, coordination is essential as sponsors pursue increasingly complex modalities. Programs place greater demands on analytical development, process understanding, comparability assessments, and control strategies, among other disciplines.

Artificial intelligence will help collect, organize, and analyze data. Advanced process monitoring and real-time release testing can offer value in appropriate settings.

But applying these technologies adds another set of skills and oversight requirements to our constellation. The technologies themselves do not eliminate the need for people and functions to work together.

In this environment, the standout CDMO will treat outsourcing as the strategic alliance we've long discussed in this publication. But that alliance must manifest at the CDMO itself, connecting disciplines, departments, and facilities.

Summed up, your guiding question is:

How do we ensure and monitor that a CDMO operates as a Constellation of Unified Skills in its service to our organization?

Start by asking them.

Listen carefully to how prospective partners answer these questions during due diligence:

• How do you foster cross-functional collaboration?
• Who has the authority to resolve conflicts between functions?
• How are problems escalated?
• How do lessons from earlier development stages inform later decisions?
• How do you maintain consistent processes and knowledge when work transfers between sites?

You shouldn't have to thank your lucky stars that your CDMO's people, functions, and facilities work together. Your partner should be able to show you how it shines brighter than the others.