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Chemistry, Manufacturing, and Controls (CMC) for Effective Drug Development
Our experts help to ensure that your drug substance reaches the right place in the body, in the right amount and at the right time, to exert its optimal pharmacological effect.
Expertise to help you build a strong CMC strategy
In-depth knowledge about your specific project, product development, and drug delivery is central to a successful CMC program. Our CMC experts help you define the manufacturing process, quality control, specifications and stability of your product, helping you to identify gaps and build a strong CMC strategy. We establish close collaboration with identified contract manufacturers to gain essential information about a product’s manufacturing, quality, and stability. We develop a thorough understanding of the unique features of the drug substance and the drug product necessary to build relevant regulatory documentation.
Cytel’s experts can help you outline the best path forward by addressing critical questions such as whether the drug substance has poor solubility, is sensitive to environmental degradation, and is well absorbed from the intended administration site in the body.
Contact usComprehensive Development Support
Our consultants provide tailored advice on formulation, process, and analytical development to ensure optimal drug efficacy and stability.
Regulatory Guidance
We guide you through procurement, quality standards, and CMC documentation compilation necessary for clinical trial applications and product registration.
Partnership Facilitation
We can help you in procuring contract research and manufacturing organizations (CDMOs) tailored to your drug’s specific development and production needs.
Strategic Advisory Services
We offer expert support in scientific publications, advice meetings, and due diligence assessments to strategically advance your product’s market readiness.
Formulation Development Expertise Across All Clinical Trial Phases
Understanding substance properties—such as solubility, permeability, and stability—is crucial for all formulation development. These properties determine the feasible types of formulations and routes of administration.
Lifecycle formulation types:
- Toxicity studies formulations: Designed to administer very high doses to various animal species.
- First time in human (Phase I) studies formulations: Offers the flexibility to administer doses within a wide range.
- Phase II studies formulations: User-friendly for patients to manage at home.
- Pivotal clinical and commercial formulations: Developed for large-scale manufacturing at a reasonable cost.
- Additional formulations may be developed for special patient groups, such as children.
Placebo: The Formulation Challenge Developers Forget
Cytel’s experts help ensure your clinical trial integrity through the development of sophisticated placebos that match the active product in form, color, taste, and texture. This involves not only the removal of active substances but may also require the addition of specific excipients to maintain the trial’s blinding integrity. While not always as complex as developing the active drug, placebo formulation demands detailed attention to dosage, route of administration, and sensory characteristics.
Helping You Navigate CMC Regulatory Guidelines and Authority Meetings
Staying within regulatory guidelines typically eliminates the need for discussions with regulatory authorities. However, deviations from these guidelines or any special solutions should be communicated to the authorities as early as possible to avoid rejection of market applications. It is crucial to remember that the substance and product used in pivotal clinical studies must be representative of the final marketed product. We can help you establish a complete and aligned CMC strategy before beginning these clinical studies.
Learn More
The Road to First-in-Human Trials: Insights from a Real-World Example
In this webinar, co-hosted by our client Dicot AB, we explore their path to the first-in-human trial. We discuss navigating drug development, regulatory strategy and decision-making, authority communication, and adhering to regulatory guidelines.
Watch the webinar
Related Insights
The Road to First-in-Human Trials: Insights from a Real-World Example
First-in-Human Drug Substance and Formulation: The Challenge of Achieving Flexibility and Quality
Drug Manufacturer Auditing: Ensuring Quality, Control, and Safety
How to Save Time and Limit Costs toward First-in-Human Clinical Trials
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