CMC challenges in the development of breakthrough drugs

Creating a new drug takes a lot of time, effort and resources. Many assume that drug development is straightforward, with final products approved fairly quickly, but the drug approval timeline can take 10 to 15 years. Of every 10,000 compounds analyzed, only one or two are ultimately approved.

Drug development is extensive, starting with pinpointing the DNA proteins that drugs can target before ensuring the product is safe by running various tests. Several clinical trials are also required before final approval is granted, further adding to the complexity.

Image credits: Design Space InPharmatics LLC

Incorporating chemistry, manufacturing and controls (CMC) is central to this process, ensuring the highest standard for new medicines during creation and approval.

Compliance with CMC requirements during development confirms the quality and safety of new medicines. This article examines CMC and its involvement in drug development.

Ensure regulatory compliance

Compliance with regulatory requirements is essential in drug approval. The CMC section of a regulatory submission will be thoroughly examined for evidence that the drug can be commercially manufactured consistently while meeting strict quality standards.

Regulatory agencies such as the US Food and Drug Administration or the European Medicines Agency require comprehensive data confirming that a drug’s manufacturing process is reproducible and robust.

Inadequate or incomplete CMC documentation can cause significant delays in approval timelines or even rejections, highlighting the need for strict compliance.

Manage resources

While innovative organizations may not have extensive internal CMC resources or capabilities, developing breakthrough medicines is often within their reach.

Partnering with contract manufacturing organizations becomes strategically necessary to overcome these limitations. This enables specialized manufacturing and analytical expertise and facilitates advanced new therapeutic development despite fundamental resource limitations.

Customized approach

Each drug candidate is unique, meaning a one-size-fits-all approach to CMC is impractical.

Developing and optimizing analytical methods and manufacturing processes should be custom designed around the following properties of the drug:

• Special attributes
• Therapeutic goal
• Intended clinical use

This requires an in-depth understanding of the drug’s process parameters and critical quality attributes, which are essential for ensuring a product’s efficacy, quality and safety.

Documentation

Careful documentation of all CMC activities is fundamental to successful drug development and includes comprehensive data on:

• Production processes
• Quality control measures
• Changes made during development
• Stability data

Such documentation is essential for submissions to regulators and a fundamental element in ensuring accountability and traceability of the drug’s lifestyle.

Telling stories

When completing new drug applications or biologics marketing authorization applications, it is important to formulate a compelling and coherent CMC story in regulatory submissions.

This story should convincingly demonstrate complete control over the drug manufacturing process and emphasize maintaining quality control at all stages of drug development.

A well-crafted CMC narrative can positively impact the regulatory review process, demonstrating the applicant’s commitment to patient safety and product quality.

Plan early

CMC considerations should be explored early in drug development to preemptively address potential problems.

Early planning allows drug developers to streamline the approval process by generating accurate, comprehensive data sets that meet regulatory requirements. This enables more effective resource allocation and risk management throughout the development lifecycle.

Expertise and partnerships

The complexity of CMC activities requires technical and regulatory expertise. Organizations, especially smaller organizations with limited internal capabilities, benefit from strategic partnerships with CMC regulatory consultancies.

These partnerships provide specialized knowledge and insights into regulatory strategies, increasing an organization’s internal expertise, improving the quality of submissions and increasing the likelihood of regulatory approval.

Addressing these critical CMC considerations can significantly impact the success of breakthrough drug development.

Through regulatory compliance, careful planning, effective resource management and strategic partnerships, pharmaceutical companies can better understand the drug development process, increasing the likelihood of bringing innovative therapies to market.

Summary

Incorporating CMC into drug development is critical to ensure product quality; it acts as a lens that focuses on various aspects of drug development and ensures that they function appropriately.

By following the CMC recommendations, organizations can:

• Comply with the essential regulations that may result in sanctions or fines if violated
• Save money by avoiding procedural issues that can delay or hold back development
• Ensure that the unique properties of the drug are taken into account, maximizing product quality

If a drug is to be approved, the development process requires uniformity and reliability, and CMC can help with that.

CMC considerations in drug development can be complicated, so it is important to seek expert advice from companies like DS Inpharmatics to fully understand the process.

The experts at DS Inpharmatics can provide information and support throughout the entire CMC process, whether it concerns medicines or substances.

Acknowledgments

Produced using materials originally written by Meranda Parascandola of Design Space InPharmatics LLC.

About Design Space InPharmatics LLC

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

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

Whether advocating CMC strategy, directing CMC activities, or developing CMC submission content that represents the best interests of emerging biotechnology, we focus on the critical CMC issues and build programs that accelerate the development promote.

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