Crystallization Process Development
Solid-state studies of APIs form the link between their chemical synthesis and subsequent formulation development. Designing the solid and particulate forms of specific APIs is of importance. Crystallization is a key unit operation in the production of APIs. Reliable crystal form studies ensure reproducible and scalable production of the desired crystal form selected from solid-state studies. Issues such as oil-out, solvent and impurity entrapment, multi-modal particle size distributions and previously unseen polymorphic transitions often require significant additional time and investment to circumvent. BOC Sciences's crystallization process development services help customers develop a scientific and rational crystallization processes to generate the selected crystal form and improve the overall quality of the product by optimizing yield, solvent residue, particle size and particle distribution, and bulk density.
Figure 1. The manufacture of active pharmaceutical ingredient. (OGrady, D.; et al. 2006)
Our Services
To make it easier and better for researchers, BOC Sciences provides crystallization process development service in a competitive fashion. We have provided a more efficient way to increase the number of new drugs, greatly shorten the R&D cycle, and reduce the development costs
Process development for specific polymorph
Our experts assist our customers in the development of crystallization processes for their preferred polycrystals
- For metastable crystal forms: our team is able to successfully separate the resulting crystals from the solvent system by controlling the supersaturation of the solution
- For stable crystal forms: we help to determine the ideal process via balancing the crystallization conditions to increase the purity of the crystal form and improve the crystallization yield
Optimization of the crystallization process
Our crystallization process optimization services include improving crystal habit and particle size
- Needle-like crystals may break easily during stirring and filtration, and a large number of secondary nucleation sites can be generated that negatively affect the final crystal size and morphology. One of the goal of our process optimization is to avoide such kind of crystals
- We can perform a systematic investigation of the particle size distribution to reduce the risks associated with uneven particle size distribution, which may lead to dissolution problems and quality fluctuations in crystal morphology
Integrated crystal development solutions
BOC Sciences has combined our computational and experimental expertise to address multiple aspects of its pharmaceutical solid-state development efforts. Our scientists offer the following solutions:
- Solid-state characterization for lead molecules
- Solubility improvement studies
- Crystal structure determination for challenging molecules
- Polymorph risk assessment
- Polymorph patent breakthrough studies for generic drugs
Instruments
- Powder X-ray diffractometer (pXRD)
- Differential scanning calorimeter (DSC)
- Thermal gravimetric analyzer (TGA)
- Polarized light microscopes (PLM)
- Particle size distribution analyzer (PSD)
- PAT tools, such as focused beam reflectance measurement (FBRM) and Reactor IR (online IR)
Why choose BOC Sciences?
Our dedicated CMC team has provided tailored solutions to our clients from engagement to launch. With many years of industry experience, we provide clients with the following:
- Comprehensive, integrated CMC services with a flexible service model that grows with your programs
- Knowledgeable industry experts who deliver scalable, actionable insights
- World-class facilities and equipment that remain at the forefront of the global pharmaceutical research, analytical and development standards
- Our comprehensive services support products at every stage of the product lifecycle, from early-stage discovery to full commercial cGMP manufacture
- A focus on risk management that is designed to ensure completion of your technical goals
BOC Sciences provides professional, rapid and high-quality services of crystallization process development at competitive prices for global customers. Personalized and customized services of crystallization process development can satisfy any innovative scientific study demands. Our clients have direct access to our staff and prompt feedback to their inquiries. If you are interested in our services, please contact us immediately!
Reference
- OGrady, D.; et al. PAT and the Crystallization Toolkit. Pharmaceutical Manufacturing. 2006.
