CMC Insights
September 2026

Friday, September 4, 2026

FDA Pushes Earlier CMC Readiness

Verta Life Sciences

Regulators have been unusually active this summer, with several July and August developments that could materially affect how drug and biologics companies approach CMC strategy, analytical development, manufacturing readiness, and regulatory interactions.

The Key Take Away

Across these developments, regulators appear to be moving in the same direction:

CMC can no longer be treated as a workstream that catches up to clinical development later.

For sponsors, the key questions increasingly become: Is the process sufficiently understood? Are the analytical methods appropriate for the development stage? Are critical quality attributes clearly defined? Can manufacturing changes be supported through comparability? Is the stability program keeping pace with development? And is there a credible path from today’s clinical process to tomorrow’s commercial process?

Companies that address these questions earlier have a better chance of avoiding late-stage validation, manufacturing, and regulatory bottlenecks.

Here are four developments sponsors should have on their radar.

1) FDA: Accelerated Clinical Development Needs Accelerated CMC Readiness

Strategy document — July 23, 2026

On July 23, FDA highlighted its strategy for improving Chemistry, Manufacturing, and Controls readiness for products moving through accelerated clinical development.

The challenge is familiar: clinical programs can move quickly while process development, analytical methods, stability programs, validation, and commercial manufacturing readiness lag behind.

FDA is encouraging sponsors to:

  • Build a CMC development plan earlier in the program
  • Identify CMC risks and critical milestones before they become filing constraints
  • Use dedicated CMC meetings with FDA to address issues proactively
  • Resolve focused questions through mechanisms such as Type D meetings
  • Begin planning for manufacturing and facility readiness well ahead of NDA or BLA submission

FDA also continues to signal that science- and risk-based flexibility may be possible for accelerated programs, but sponsors need a clear strategy for how remaining CMC gaps will be addressed.

What this means: Companies pursuing Fast Track, Breakthrough Therapy, RMAT, or other accelerated pathways should evaluate whether their CMC program is progressing at the same speed as their clinical program.

2) FDA Modernizes Container-Closure Expectations

Draft guidance — August 2026

In August, FDA issued new draft guidance on Container Closure Systems for Human Drugs and Biological Products.

The guidance introduces a more integrated, risk-based approach covering material safety and compatibility, protection of the drug product, container-closure integrity, manufacturing interactions, storage and handling, system performance, and suitability for the intended product and use.

Importantly, the guidance is relevant not only to commercial applications but also to IND-stage programs, biologics, and combination products.

FDA also indicated that additional guidance is expected around areas such as extractables and leachables and novel container-closure technologies.

What this means: Packaging and container-closure strategy should increasingly be considered part of development-stage CMC planning, not simply a late-stage commercialization activity.

3) FDA Clarifies CMC Expectations for Cell and Gene Therapies

Final guidance — August 2026

FDA’s August guidance addressing frequently asked questions for cellular and gene therapy products provides practical direction across the development lifecycle.

Key CMC topics include Critical Quality Attributes, product characterization, release testing, analytical methods for first-in-human studies, process characterization and validation, Process Performance Qualification, stability, manufacturing changes and comparability, and CMC readiness for BLA submission.

The guidance also reinforces the importance of engaging FDA early through INTERACT, pre-IND, Type D, and other formal meetings when significant manufacturing or analytical questions arise.

What this means: CGT developers should establish a clear path from early product characterization to a commercially sustainable control strategy much earlier than in traditional development models.

4) EMA Expands Technical Guidance for Biological Products

Living Q&A — revised July 20, 2026

EMA also updated its Q&A guidance for biological medicinal products in July.

The additions and revisions touch several recurring biologics CMC challenges, including host-cell protein testing, endotoxin testing, viral filtration, pre-use post-sterilization integrity testing, potency testing, AAV infectious titer, master cell bank changes, reference-standard qualification, biosimilar acceptance criteria, and comparability following manufacturing changes.

What this means: Biologics developers should assess whether current analytical and control strategies remain aligned with evolving European expectations, particularly when planning process changes, global development programs, or future marketing applications.

How Verta Life Sciences can help

Verta Life Sciences supports drug and biologics companies across the CMC lifecycle, including drug substance, drug product, analytical development, regulatory strategy, quality, CDMO management, validation, and manufacturing readiness.

If your program is approaching an IND, accelerated development milestone, Phase III, or NDA/BLA, now may be a good time to evaluate whether your CMC strategy is keeping pace with the program.

Have a CMC challenge you are working through? We’d be happy to connect at experts@vertals.com.

Sources & further reading

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