We are ready to execute a single CMC task or create and implement a full CMC strategy that is appropriate for you and your company.
A well-thought-out CMC strategy is key to project success as it ensures sufficient drug is available at any stage of development. CMC is the sum of, first, the definition of the properties of the final drug and methods to measure and quantify them (chemistry); second, the processes by which the drug is made and an understanding of the steps that critically affect product quality (manufacturing); and third, a control strategy, based on molecule and process understanding, that ensures consistency between batches (control).
Many different aspects contribute to CMC, some of which are highlighted in the pages in this section. The more these aspects are considered parts of a whole, the higher the likelihood of a successful CMC strategy. In addition, it is critical to properly integrate a CMC strategy with regulatory, clinical, pre-clinical, and quality strategies.
Any CMC strategy needs to be a function of the company executing it, the indication they are pursuing, and the particular details of the drug.
At 3D-PharmXchange, we have extensive experience with many different drugs, for different indications and administration routes, in different companies. Our expertise ranges from small molecules, monoclonals, vaccines, and biotechnology-derived products to novel therapies such as oligonucleotides and advanced therapy medicinal products (ATMP) including gene and cell therapy. We have worked with our own pre-clinical, clinical, and regulatory colleagues, or with those in other companies. We bring all this experience to help you craft the best approach for your company.