Developing innovative pharmaceutical drugs and technologies is a complicated process. A robust chemistry, manufacturing, and controls (CMC) strategy is critical to determining a new drug’s success or failure.
CMC consulting is central to translating a drug’s target profile into an end product by defining its dosage form, formulation, and manufacturing process. Every aspect of the drug’s development complies with relevant regulatory requirements.
This article examines the work of CMC consultants and how their expertise and guidance are helping to advance new technological advancements in drug development.
Image Credit: Design Space InPharmatics LLC
The role of CMC in drug development
Establishing a robust CMC strategy that effectively controls a clinical program can address potential developmental risks while avoiding pitfalls that often stall promising therapeutics.
The CMC process involves defining product specifications and manufacturing processes to ensure product quality, safety, and consistency. This evaluation is complex and intensive, typically evolving as the program scales, necessitating ongoing adaptation and optimization.
Expertise and guidance
Working with CMC consultants is beneficial for executing successful Investigational New Drug and New Drug Applications.
They help companies avoid clinical holds and receive regulatory approval through developmental strategies that balance near-term logistical and financial considerations with long-term commercial and regulatory goals.
Experts across the field recognize the importance of understanding the drug product development timeline so it can be accurately translated into an effective CMC strategy.
This approach assists in delivering on critical milestones and ensuring the product can be tested in clinical trials and toxicology studies.
Strategic planning
A comprehensive CMC strategy considers the drug molecule, its development, and the funding supporting it. Early-stage planning is essential in defining the specific strategic objectives that inform the main timeline and required milestones.
It relies on a cost-effective approach that balances short- and long-term considerations. It supports comparability between early-phase processes and eventual good manufacturing practice (GMP) manufacturing at larger scales.
Insourcing versus outsourcing
Another crucial aspect of a strategy is the decision to insource or outsource CMC activities. Due to the high costs of in-house development and manufacturing, significant shifts toward outsourcing have been observed throughout drug development.
Contract development and manufacturing organizations (CDMOs) have evolved in recent years and now offer services that empower small biotechs to remain competitive against larger companies.
Selecting the right CDMO is important and requires numerous considerations, including the core internal capabilities required and the novelty of the technology platform used.
The role of CDMOs
CDMOs play a crucial role in assisting companies with developing a CMC strategy for their molecule, leveraging their expertise and infrastructure to aid between early-phase development and GMP-compliant, scalable manufacturing.
Pursuing a single partner to undertake all outsourced activities in the initial stages makes the decision of CDMO critical to avoid weak supply chain links.
Summary
DS Inpharmatics boasts significant experience in drug development matters. The right strategic partner is key to a drug development company’s success, and the company’s CMC consulting services have been specifically designed to facilitate new technological advancements in drug development.
It offers critical guidance, from formulation to CMC regulatory compliance, employing its comprehensive approach and extensive experience in supporting companies to balance short-term logistics with long-term commercial and regulatory goals.
DS Inpharmatics’ CMC experts craft tailored strategies that address a program's distinct challenges, ensuring product quality, safety, and consistency at each step.
The company’s consultants provide the insights needed to make informed choices that align with business objectives, whether the client opts for an insourcing- or outsourcing-based approach.
A hybrid approach is often an ideal solution, with many companies combining internal capabilities with strategic external partnerships to enhance innovation and optimize resources.
DS Inpharmatics is committed to supporting the drug development journey from concept to commercialization. The company focuses on overcoming potential challenges and mitigating risks, ensuring that any developed CMC strategy is scalable, robust, and successful.
References and further reading
- Cytiva. Getting CMC Right for Emerging Technologies. BioProcess Online. https://www.bioprocessonline.com/doc/getting-cmc-right-for-emerging-technologies-0001. Published 20th December 2023. Accessed 6th June 2024.
- Pharmaceutical Quality – Chemistry, Manufacturing & Controls| PQ/CMC. U.S. Food & Drug Administration (FDA). https://www.fda.gov/industry/fda-data-standards-advisory-board/pharmaceutical-quality-chemistry-manufacturing-controls-pqcmc. Updated 19th April 2024. Accessed 6th June 2024.
- Quality Guidelines. International Council for Harmonisation of Technical Requirements for Human Use. https://www.ich.org/page/quality-guidelines. Accessed 6th June 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.
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