Crystallization Process Development

CD Formulation has deep expertise in crystallization process development. We use a quality-by-design approach to crystallization process development, aiming to provide a robust, scalable, and transferable crystallization program to help accelerate clinical development and minimize risk in any downstream activities by eliminating batch-to-batch variability.

Why Do Crystallization Process Development?

Crystallization process control is a common problem for drug R&D workers. Different crystal forms of the same drug molecule may have significant differences in properties such as crystal structure stability, manufacturability, and bioavailability, which directly affect the efficacy and developability of the drug. Excellent crystallization process can make the raw material drug have specific purity, particle size and crystallinity, that is, higher quality drug crystals, effectively solving the above problems. Therefore, the development of crystallization process is often an essential step in the pharmaceutical production process.

Our Workflow for Crystallization Process Development

Crystallization process development is a complex process that requires many experiments and adjustments to obtain the best crystallization process. The crystallization process development of CD Formulation is as follows:

1. Determine the crystallization goal: first, you need to clarify what the solute is to be separated, and the crystallization requirements that need to be achieved (such as crystal morphology, crystal size, purity, etc.).
2. Experimental design: according to the crystallization goal, design the experimental plan, including solvent selection, solution concentration, temperature, stirring rate, cooling rate and other conditions.
3. Experiment execution: conduct experiments according to the experimental plan, observe the crystallization situation, and collect data.
4. Data analysis: Perform statistical analysis on experimental data to determine optimal crystallization conditions.
5. Determination of process parameters: according to the optimal crystallization conditions, determine the process parameters, including crystallization temperature, cooling rate, stirring rate, seed crystal type, seed crystal addition time, seed crystal addition amount, etc.
6. Process verification: verify the determined process parameters, observe the crystallization situation, collect data, and determine the feasibility and stability of the process.
7. Process improvement: during the production process, the process is improved according to the actual situation to improve the yield and crystallization quality.

Advantages of Our Crystallization Process Development Services

• With high-standard laboratories, advanced equipment, and experienced researchers, we can provide customers with the most advanced solutions.
• Combined with the crystallization properties of the product and industrial reality, rationally design the optimal crystallization process to meet customer sample scale-up production needs and obtain the target solid form efficiently and stably.
• Have a deep understanding of the crystallization process, master the technology of big data analysis and AI prediction of process parameters, and have the ability to innovatively design crystallization equipment
• Reasonably apply scientific and engineering principles to every step of the crystallization process, not only improving the reliability of the process and product quality, but also improving the efficiency of process development.

CD Formulation adheres to the concept of Quality by Design (QbD) and develops stable, reproducible, and transferable crystallization processes based on key quality attributes and key process parameters to continuously meet the needs of customers in chemical drug crystallization. If you are interested in our services, please do not hesitate to contact us for in-depth discussions.