A guide to critical design review process (CDRP) in chemistry, manufacturing, and controls (CMC): What you need to know

Chemistry, manufacturing, and controls (CMC) is key in drug development, ensuring novel therapeutics’ consistency, quality, and safety.

The approval process for new medications can take 10–15 years, increasing expenses and potentially limiting patient access.

The CMC Development and Readiness Pilot (CDRP) program seeks to limit the impact of this bottleneck by encouraging collaboration between the United States Food and Drug Administration (FDA) and drug sponsors, accelerating the delivery of life-saving treatments to patients who require them.

This article explores how CDRP is transforming CMC and revolutionizing the drug development landscape.

Image Credit: Design Space InPharmatics LLC

Purpose of the CDRP program

The challenges linked to the accelerated clinical development of biologics and drugs prompted the launch of the CDRP program. Its objective is to expedite the CMC development phase, ensuring promising therapies reach patients quicker, especially when early access offers crucial clinical benefits.

Key aspects of the CDRP program

Enhanced FDA-sponsor communication

A primary feature of the CDRP program is improved communication between sponsors and the FDA, which enables improved exploration and implementation of science- and risk-based regulatory approaches to significantly streamline the CMC development process.

The program facilitates regular and detailed discussions, allowing sponsors to gain timely, product-specific advice in line with expedited clinical development timelines.

Regulatory flexibility

The CDRP program offers various regulatory flexibility options, including alternative approaches to process validation, stability data requirements, and analytical procedures.

It also allows the marketing of batches manufactured via clinical manufacturing processes, enabling the CDRP program to minimize the time and resources necessary to scale up commercial production.

Selective participation and eligibility

The CDRP program began accepting limited applications for participation on April 1, 2023. It is aimed at products with faster clinical development timelines, including Fast Track, Breakthrough Therapy, or Regenerative Medicine Advanced Therapy designations.

This selective approach ensures the program’s resources and benefits are specifically directed towards therapies that offer substantial early clinical benefits to patients.

Implications for the pharmaceutical industry

The CDRP program’s emphasis on accelerated CMC development has several key implications for the pharmaceutical industry:

Accelerated drug development: The CDRP program can considerably reduce the time required to bring new therapies to market by facilitating earlier interactions and offering regulatory flexibility.

Increased innovation: The program encourages adopting innovative approaches to CMC development, resulting in more effective and efficient drug manufacturing processes.

Enhanced patient access: Patients are, ultimately, the core beneficiaries of the CDRP program. They can obtain earlier access to potentially life-saving therapies.

The CDRP program is an FDA initiative to align the CMC development process with the expedited clinical timelines of promising innovative therapeutics.

It aims to accelerate patient clinical treatment availability through regulatory flexibility, enhanced communication, and selective participation.

As it progresses, the program is anticipated to set new standards in CMC development, foster innovation, and enhance patient outcomes.

Summary

Meeting appropriate regulatory requirements can take time when developing a new drug or medication. Specialized knowledge is required to ensure a drug application includes all information needed for approval.

DS Inpharmatics leverages its experience with CMC methods to offer its clients advice and support in optimizing their CMC documentation and strategy. It supports its clients’ drug development programs, working to ensure their advancement.

References and further reading

1. Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program Opportunity. National Institutes of Health. https://seed.nih.gov/aboutseed/news/chemistry-manufacturing-and-controls-development-and-readiness-pilot-program. Published 13^th January 2024. Accessed 21^st May 2024.
2. FDA Announces Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program. National Institutes of Health. https://seed.nih.gov/aboutseed/news/fda-announces-chemistry-manufacturing-and-controls-development-and-readiness-pilot. Published 15th November 2022. Accessed 21^st May 2024.
3. Patel P. Chemistry, Manufacturing, and Controls Assessment for Expedited Programs. U.S. Food & Drug Administration. https://www.fda.gov/media/170953/download. Published 6^th June 2023. Accessed 21^st May 2024.

Acknowledgments

Produced from materials originally authored by Meranda Parascandola from Design Space InPharmatics LLC.

About Design Space InPharmatics LLC

DSI provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.

Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence.

Whether advocating CMC strategy, directing CMC operations, or developing CMC submission content that represents the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.

Sponsored Content Policy: News-Medical.net publishes articles and related content that may be derived from sources where we have existing commercial relationships, provided such content adds value to the core editorial ethos of News-Medical.Net which is to educate and inform site visitors interested in medical research, science, medical devices and treatments.