CDMO Process Development: What to Look for in a Manufacturing Partner

Sometimes the process exists only at laboratory scale.

Sometimes it works, but not consistently.

Sometimes the science is sound while yield, purification, analytical methods, scale, or manufacturing controls still need significant work.

That is where process development becomes central to CDMO selection.

If a program still needs development, choosing the manufacturer based only on production equipment can be a mistake.

The sponsor may need a development partner first and a manufacturer second.

Process development is the work required to build, optimize, understand, and prepare a manufacturing process for reliable production.

The exact activities depend on the product and modality.

They may involve:

• upstream process development
• chemistry development
• downstream purification
• formulation
• analytical development
• scale-up
• process optimization
• raw-material evaluation
• manufacturing controls

The objective is to move from a scientifically workable process toward one that can be executed consistently in a manufacturing environment.

One sponsor may already have:

• a defined process
• established analytical methods
• known raw materials
• demonstrated scale
• clear manufacturing instructions

Another may have little more than proof that the product can be made.

Those programs need different CDMOs.

Before sourcing, sponsors should be realistic about process maturity.

That allows the CDMO to estimate the actual development work rather than treating the project as a simple technology transfer.

Technology transfer moves an existing process into a new manufacturing environment.

Process development changes or improves the process itself.

In practice, the two can overlap.

A sponsor may begin a transfer and discover that:

• the receiving equipment behaves differently
• scale creates a new problem
• yield falls
• purification needs improvement
• analytical methods are not ready

At that point, additional development work may be needed.

A good CDMO should be able to distinguish between transfer work and genuine process development.

Sponsors should be able to explain where the process is mature and where uncertainty remains.

Examples might include:

• poor yield
• inconsistent product quality
• purification bottlenecks
• scale limitations
• unstable formulation
• incomplete analytical methods
• difficult raw materials
• equipment incompatibility

This helps the CDMO understand the actual problem it is being asked to solve.

For biologics and certain other modalities, upstream development may involve improving the conditions under which the product is produced.

Potential areas can include:

• media
• feeds
• cell culture conditions
• production parameters
• scale-up
• productivity

The relevant work depends heavily on the modality.

Sponsors should look for a CDMO with development experience that matches the process rather than generic development capacity.

Downstream development focuses on recovering and purifying the product after it has been produced.

Depending on the modality, this may include:

• clarification
• filtration
• chromatography
• concentration
• impurity removal
• buffer exchange

A manufacturing process that produces the product successfully can still be commercially impractical if downstream recovery is weak.

That makes purification expertise an important selection criterion for many programs.

For small molecules, process development may involve:

• route optimization
• reaction conditions
• impurity control
• crystallization
• isolation
• process safety
• scale-up

The same term, “process development,” can therefore mean very different work depending on the product.

Sponsors should make sure the CDMO's development expertise matches the manufacturing problem.

A process can work beautifully at laboratory scale and become difficult once volumes increase.

Scale can affect:

• mixing
• heat transfer
• mass transfer
• reaction behavior
• filtration
• purification
• equipment performance

The goal of development is not merely to demonstrate that the product can be made.

It is to create a process appropriate for the manufacturing scale required by the program.

Process development that ignores the receiving facility can create problems later.

If the intended CDMO uses different equipment from the laboratory or previous site, the development team should understand those differences.

This can reduce the risk of developing a process that is difficult to implement in the actual manufacturing environment.

For sponsors considering several CDMOs, equipment compatibility may therefore become part of selection.

A process cannot be optimized effectively if the team cannot measure what is happening.

Analytical methods help teams understand:

• product quality
• impurities
• yield
• potency
• stability
• consistency

This makes analytical development closely connected to process development.

Sponsors should evaluate whether the CDMO can support both or how those functions will be coordinated across partners.

Early development often involves experimentation.

The goal is not simply to produce one successful batch.

The team needs enough process understanding to recognize:

• which parameters matter
• where variability comes from
• which steps are sensitive
• how changes affect product quality

The depth required depends on the development stage and applicable regulatory expectations.

Sponsors should work with qualified CMC and regulatory teams to determine the appropriate development strategy.

A sponsor under timeline pressure may naturally prioritize speed.

But development shortcuts can create problems later if the process has to be reworked during scale-up or technology transfer.

The fastest proposal is therefore not automatically the best proposal.

Sponsors should understand what work the CDMO believes is necessary and why.

A strong development partner should be able to explain where it sees risk in the process.

A process-development proposal should be specific enough to evaluate.

Sponsors should understand:

• experiments planned
• development objectives
• deliverables
• decision points
• expected sponsor inputs
• timeline
• connection to GMP manufacturing

Without that clarity, two development proposals may appear comparable while covering very different amounts of work.

A sponsor may choose one organization for development and another for commercial manufacturing.

That can work.

But every additional manufacturing transfer introduces work and risk.

If the development CDMO is not expected to become the long-term manufacturer, the sponsor should make sure the resulting process and documentation can move elsewhere.

The manufacturing strategy should therefore consider both immediate development needs and potential future transfers.

Pharma Connect Navigator helps sponsors search for manufacturing partners based on the requirements and maturity of a specific program.

Sponsors can indicate their development stage, required capabilities, scale, support needs, timing, budget, geography, and other project factors.

PCN helps identify potentially relevant CDMO companies and facilities and gives teams a structured way to compare project fit.

That can help a sponsor distinguish between a company that simply has manufacturing equipment and one that appears better aligned with the level of development support the program requires.

Detailed development scope and technical feasibility should still be discussed directly with the CDMO.