Introduction to CDMO partnerships

Why biotech companies need the right CDMO partner

Biotech companies - particularly early-stage or small-to-mid-sized firms - often face limitations in their internal capabilities to support the complex demands of drug development and manufacturing. Outsourcing becomes essential as therapies become more advanced, from monoclonal antibodies and antibody-drug conjugates (ADCs) to cell and gene therapies and personalised medicine.

Partnering with contract research organisations (CROs) and contract development and manufacturing organisations (CDMOs) allows biotech companies to access specialised expertise (including regulatory know-how), cutting-edge technologies, and Good Manufacturing Practice (GMP)-compliant facilities that might otherwise be out of reach.

But what exactly differentiates a CRO from a CDMO? Simply put:

• CROs manage clinical trial design, execution, and data analysis.

• CDMOs support product development and manufacturing, including formulation development, process optimisation, scale-up, technology transfer, GMP manufacturing, and regulatory compliance.

This article offers a practical guide to help you select the right CRO or CDMO partner, with key considerations tailored to the unique needs of early-stage biotech developers.

How to choose the right CRO or CDMO for your biotech product development

Start by identifying your internal drivers. Are you outsourcing due to limited in-house expertise, resource constraints, or as part of a strategic growth plan? Your goals will shape whether you need a CRO, a CDMO, or both.

Next, decide on the most suitable outsourcing model:

• Tactical engagement for short-term needs or specialised gaps in capability

• Preferred provider relationships for repeat services where consistency is key

• Strategic alliances for integrated, long-term collaboration and innovation co-development

Your product development stage is also key. Early-stage projects may rely on a CRO for tasks like preclinical studies, clinical trial design, regulatory strategy, and site management. As you move towards scale-up and commercialization, a CDMO becomes essential, offering process development, GMP manufacturing, and support for product launch.

Determine whether you need a full-service partner or a specialist. A full-service CRO or CDMO can support you across multiple development stages, simplifying coordination and enabling integrated project management. However, a specialist might be better suited for complex challenges such as advanced therapy medicinal products (ATMPs), controlled substances, or novel drug delivery mechanisms. For example, a developer of a cell or gene therapy (an ATMP) might partner with a CDMO that specialises in cell processing, whereas a program involving a controlled substance would require a CDMO with the proper licences and security protocols.

Involve key stakeholders across R&D, quality, regulatory, legal, and finance early in the process. Their insights will help you evaluate potential partners from every angle, balancing scientific needs with budget constraints, regulatory compliance, and business priorities.

Both CROs and CDMOs offer unique advantages, but successful partnerships rely on shared goals, open communication, and aligned expectations. Ultimately, the partner you choose should feel like an extension of your internal team.

Key factors to consider when selecting a CRO or CDMO for biotech success

When vetting potential partners, pay special attention to the following factors.

Ability to scale and flexibility

Choose a partner that can grow with your project, from early development to commercialisation. This includes the ability to scale production volumes, adjust the scope of services, and quickly integrate new requirements as your project evolves. Flexibility is particularly important for biotechs operating in fast-moving or uncertain therapeutic areas, where plans often shift due to funding changes, regulatory feedback, or new clinical data.

Ask potential partners:

• Can they support both small-scale and large-scale production?

• How have they handled project changes or delays for other clients?

• Are their systems and teams built to adapt quickly?

A flexible CDMO is not just one with capacity; it is one that has built-in agility to manage the unexpected without compromising quality or timelines.

Experience and expertise

Look for a partner with proven experience in your specific therapeutic area, product type, and regulatory environment. For example, if you are developing an mRNA therapy, a CDMO with nucleic acid handling capabilities, lipid nanoparticle (LNP) formulation experience, and RNA-specific quality controls will be more valuable than a generalist.

When assessing a partner’s track record, request case studies, client references, and regulatory inspection histories relevant to your product. Don’t underestimate the value of institutional knowledge; partners who’ve worked with similar modalities can flag risks early and offer tailored solutions.

Quality of facilities, technologies, and resources

For CRO partners, evaluate whether they offer modern, validated digital tools for clinical trial design, remote monitoring, data analytics, and patient engagement. For CDMOs, inspect their physical infrastructure, GMP-certified manufacturing facilities, equipment qualifications, and assess the capability to handle specialised production (e.g. sterile fill-finish, biologics, or high-potency compounds).

Look for:

• Proven readiness for GMP and regulatory inspections

• Robust digital infrastructure for documentation and traceability

• Capacity for tech transfer, process validation, and batch release

Importantly, assess staff expertise, not just the facilities. Do they employ seasoned scientists and operators who understand your specific molecule and its delivery route? Afterall, people drive results.

Capacity to meet timelines and regulatory expertise

Even the best science can fail if your development timeline slips or regulatory expectations are not met. Assess a potential partner’s track record in project delivery, as well as its ability to proactively manage submission risks and respond to regulatory queries.

Ask:

• Have they submitted similar products to major regulators such as the MHRA (UK), EMA (EU), or FDA (USA)?

• Can they support critical regulatory interactions like pre-IND (pre-Investigational New Drug) meetings or Scientific Advice consultations?

• How do they handle Chemistry Manufacturing, and Controls (CMC) documentation, and how do they ensure GMP audit readiness?

A partner with global regulatory knowledge adds value far beyond compliance; they can help accelerate timelines by anticipating and resolving regulatory issues early.

Innovation and scientific knowledge

Choose a partner who actively invests in innovation, not one simply delivering status quo services. This may include capabilities like advanced analytical capabilities (e.g. multi-attribute assays, next-generation sequencing), new clinical trial models (e.g. decentralised or virtual trials), or modern continuous manufacturing techniques.

Innovation doesn’t need to be flashy. Small improvements in things like assay validation, patient retention, or downstream yield can have a major impact. During selection, ask how the organisation stays ahead of scientific and technological trends and how it applies that innovation to client projects.

Objective evaluation: use a scorecard

Use a structured scorecard to compare partners objectively. Include weighted criteria such as:

• Scientific and technical expertise

• Compliance record and audit history

• Capacity and scalability

• Communication and responsiveness

• Cultural fit and collaboration mindset

Assign numeric scores to each category and hold internal meetings to review the results. This process supports a transparent, repeatable decision even when comparing very different providers.

Remember, choosing a respected partner can strengthen your biotech’s credibility, building trust with investors, regulators, and potential acquirers by showing you’ve aligned with proven experts.

Building a collaborative relationship with your CDMO: best practices

Successful CRO/CDMO relationships go beyond legal contracts. They rely on strong interpersonal collaboration, open communication, and mutual respect.

Understand working styles

Every organisation has a unique communication and decision-making style. Discuss expectations early, for example, frequency of meetings, escalation paths for issues, reporting cadence, and decision thresholds. Misaligned assumptions often cause delays or miscommunication.

Encourage transparency from both sides. If your team has internal resource constraints or tight timelines, flag it. If your partner has scheduling limitations or upcoming audits, ensure these are known. Openness from day one builds trust and prevents surprises.

Align culturally

Cultural differences, whether organisational or geographic, can affect working relationships. For example, a US-based biotech may have a fast-paced, agile approach, while a European CDMO may employ more formal processes. Understanding and respecting these differences improves team harmony.

Make time for face-to-face interactions to build rapport. Consider site visits, cross-training days, or integrated workshops. Personal relationships matter, especially when projects hit pressure points.

Assess the team behind the partner

It’s not just about the company, it’s about the individuals who will run your project. Ask to meet the actual project manager, quality lead, and scientists who will support your programme. Their experience, communication skills, and problem-solving approach can make or break a collaboration.

If you’re considering a long-term partnership, evaluate staff turnover, training policies, and succession planning. You need continuity, especially across multi-year development programmes.

How to structure a successful collaboration with your CRO or CDMO

Once you have selected a partner, formalise the relationship with robust agreements that reflect both operational needs and strategic intent. Key agreements typically include:

• Master services agreement (MSA): Defines the legal and financial framework of the partnership

• Statement of work (SOW): Details the specific activities, timelines, deliverables, and responsibilities

• Quality agreement (QAA): Covers quality standards, documentation, change control, audits, and compliance expectations

Build in:

• Clear project milestones and go/no-go decision points

• Defined escalation paths for issues

• Regular project reviews and joint planning meetings

• Key Performance Indicators (KPIs) that reflect performance, quality, and responsiveness

This formal structure keeps both sides accountable while maintaining flexibility to adapt as the programme evolves. Do not treat contracts as static - review and update them as your relationship matures.

Governance structures for successful CRO and CDMO collaboration

Effective governance is essential for long-term partnerships. Set up a multi-level framework that allows strategic oversight and operational execution.

• Steering committee: Senior leaders from both sides meet quarterly to align on goals, budgets, and future plans

• Operational team: Day-to-day managers track milestones, resolve issues, and drive delivery

• Functional working groups: Specialists (e.g. regulatory, quality, logistics) collaborate on specific areas or challenges

Use shared dashboards and scorecards to track progress against the agreed KPIs. This visibility ensures alignment and encourages continuous improvement, even across complex, multi-site programmes.

Risk management in CRO and CDMO partnerships

Risk management is not a one-time exercise; it should be built into every phase of the partnership.

Common risks include:

• Clinical trial delays or low patient enrolment

• Manufacturing batch failures or out-of-specification results

• Regulatory feedback requiring significant rework

• Sudden partner capacity constraints or staff turnover

• Supply chain disruptions for critical materials

Develop a joint risk register with identified mitigation actions, responsibilities, and review frequency. Use scenario planning to test response readiness and resilience.

Also, establish clear change-control and deviation-management procedures from the outset. This ensures you can respond quickly to issues without disrupting quality or compliance.

Common mistakes when choosing a CRO or CDMO

Even with careful planning, early-stage biotechs can fall prey to a few classic pitfalls. Here are two common mistakes to watch out for.

Prioritising cost over value

For many young biotechs, budget pressure is intense. But prioritising the lowest cost option at the expense of long-term fit, quality, or technical ability is a mistake. Delays, rework, or failed audits are far more expensive than investing in the right partner from the start.

It’s better to focus on total value: scientific expertise, project stability, regulatory success, and speed to market.

Failing to involve stakeholders early

Another common pitfall is excluding key internal stakeholders from the selection process. If functional experts from departments like quality, regulatory, supply chain, clinical, or finance are not involved early, you are likely to miss critical requirements, misalign expectations, or face costly downstream changes. To prevent this, involve representatives from all these areas from the outset to build a robust picture of your needs and constraints.

Building a strong CRO/CDMO partnership for accelerated biotech growth

Choosing the right CRO or CDMO is so much more than a procurement decision. It is a pivotal strategic move that can define the trajectory of your biotech product. The right partner doesn’t just fill a capability gap; they bring clarity to complexity, transform uncertainty into momentum, and help you unlock the full potential of your science.

When you find a CRO or CDMO that shares your vision, brings deep technical insight, and works with you as a true collaborator, that partner becomes a catalyst for innovation, speed, and scale.

Biotech innovation has the power to change lives. By investing in the right partnerships early, you position your company not just to succeed but to lead.

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