🎙️ New Podcast Drop: 10 CMC Questions Every Emerging Biotech Must Answer in 2025! 🎙️

Are you ready for 2025? Before you push forward, make sure you’ve got answers to these 10 make-or-break CMC questions.

Our latest Podcast dives into the critical areas every emerging biotech should be thinking about — from regulatory milestones and risk management to quality assurance and future goals.

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Here’s what’s on the table:

❓ Are you on track for key regulatory milestones?

❓ Is your data analytics strategy driving smarter decisions?

❓ Have you identified and mitigated your biggest CMC risks?

These aren’t just “nice-to-have” questions — ignoring them could mean delays, missed opportunities, and costly setbacks. Get ahead now, so you’re not playing catch-up later.

Don’t let 2025 catch you off guard. Click play and make sure your CMC strategy is ready to win. 💥

Every Small Emerging Biotech with a Drug Development Program Should Ask at Year-End

As an emerging biotech company, the end of the year is a critical time for reflection and strategic planning. This period offers an opportunity to evaluate the progress and direction of your drug development program—particularly your Regulatory CMC (Chemistry, Manufacturing, and Controls) strategy.

Here are ten essential CMC-focused questions to guide your year-end review, complete with examples to illustrate their importance:

Have We Met Our (CMC) Regulatory Milestones?

If your goal was to achieve Orphan Drug Designation or Fast Track status, assess whether you’ve met the CMC requirements to support these designations. Missing these milestones can have significant downstream effects on your development timeline.

Example: Did you submit sufficient CMC data to support your Orphan Drug Designation? If not, assess the impact on your next submission timeline and understand how to close the data gaps before the next regulatory interaction.

Is Our Regulatory Strategy Still Relevant?

Regulatory expectations shift, and it's crucial to ensure your CMC strategy remains aligned with evolving FDA guidelines.

Example: Did recent FDA guidance on Nitrosamines or ICH Q13 for continuous manufacturing impact your development strategy? Reassess if your strategy accounts for these updates, especially for impurities, elemental impurities, and control strategies.

How Robust is Our Data Analytics Approach?

Your CMC strategy is only as strong as your data. Ensure your data analytics approach can support risk-based decision-making and drive predictive outcomes for your manufacturing and quality activities.

Example: Are you leveraging advanced analytics to predict batch failures? Assess how well your stability data, in-process control (IPC) data, and batch release data are integrated to identify trends and predict future manufacturing risks.

Are We Prepared for FDA Interactions?

Readiness for regulatory interactions—including Type C meetings, pre-IND, and pre-NDA/BLA meetings—is essential to avoid costly delays.

Example: Have you conducted an FDA-style review of your CMC submission? Conduct mock FDA reviews of your IND, NDA, or BLA Module 3 content to identify potential deficiencies before submission.

Have We Conducted Comprehensive Gap Assessments?

A CMC gap assessment identifies missing data, unresolved questions, or incomplete validation work.

Example: Are there critical gaps in your analytical method validation? Conduct a method performance review to ensure assay specificity, sensitivity, and reproducibility are sufficient to meet FDA expectations.

Is Our Risk Management Strategy Up to Date?

Risk management is a living process. Ensure you’ve re-evaluated supply chain risks, changes to manufacturing processes, and regulatory risks.

Example: Did you reassess your supply chain resilience? Identify key suppliers of raw materials and active pharmaceutical ingredients (APIs) and develop contingency plans for disruptions.

How Effective is Our Quality Assurance (QA) Compliance?

GMP compliance failures can lead to 483s or warning letters. Assess your QA program to ensure manufacturing processes remain inspection-ready.

Example: Did your internal audits highlight deviations that could trigger an FDA Form 483? If so, address these issues and document Corrective and Preventive Actions (CAPAs) to ensure your facility is inspection-ready.

Are We Utilizing Cutting-Edge CMC Development Practices?

Adopting modern development approaches can accelerate timelines and reduce costs.

Example: Is your company exploring continuous manufacturing or PAT (Process Analytical Technology) to enhance process control and product quality? Determine if adopting continuous manufacturing could reduce costs, improve efficiency, or provide a competitive advantage.

How Strong is Our CMC Development Program?

Your CMC program’s strength directly impacts submission success. Ensure your product’s formulation, stability, and manufacturing process are adequately characterized.

Example: Is your stability data supporting your proposed shelf-life? If not, consider accelerated stability studies to provide early insights and adjust storage conditions or packaging configurations.

What are Our CMC Goals for the Coming Year?

Set clear, CMC-specific objectives that support your regulatory strategy and business goals.

Example: Do you have plans to scale up your manufacturing process to support late-stage clinical development? Set clear goals for process validation, technology transfer, and commercial readiness activities.

🎧 Watch on YouTube

🎧 Listen on Spotify