Preclinical Research and Development
Preclinical research and development enables to provide a useful strategy for the small molecule APIs manufacturing while producing reproducible, high quality materials. In addition, preclinical development can deliver a work program with fixed budgets and timelines, as well as milestone targets and cost assumptions, allowing for transparency in scaling up estimates.
Figure 1. Preclinical drug development stages. (Steinmetz, K. L.; et al. 2009)
Our Services
To make it easier and better for researchers, BOC Sciences provides pre-clinical research and 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. Our professional teams provide pre-clinical research and development services for your small-molecule APIs to meet specific requirements, and we are capable of performing the following pre-clinical research based on the needs of the project:
- Process outline manufacturing
- Stress testing
- Impurity tracking (including PGI control)
- Specification setting
- More detailed specification and impurity synthesis studies
- Process validation
Materials research is indispensable to obtain exploitable solid forms and crystallization processes. Stability, solubility, bioavailability and processability of APIs can be significantly improved. BOC Sciences' materials science team provides comprehensive discovery support services that include solid state chemistry, solid form screening and crystallization process development.
At BOC Sciences, we guarantee that the analytical methods developed will ensure that they can be used to measure the purity and potency of your small molecule APIs and are suitable for cGMP synthesis. By working with our dedicated team, all analytical needs for their projects are met. We are committed to providing a series of high-quality services including the support of raw material release, process/intermediate testing, and final product analysis. We are particularly proud of the fact that all of our methods are developed with cGMP quality in mind and will be suitable for validation at the appropriate stage.
Our custom non-GMP production labs are available in 50 L containers and 100 L working containers, as well as multi-kg chromatography capabilities. We typically produce 3-5 kg batches for GLP toxicity studies (CoA, TSE). We also provide compound support for our customers, including impurities, metabolites, stable labeled compounds and building blocks.
Figure 2. Preclinical flow diagram. (Steinmetz, K. L.; et al. 2009)
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 preclinical research and development at competitive prices for global customers. Personalized and customized services of preclinical research and 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
- Steinmetz, K. L.; et al. The basics of preclinical drug development for neurodegenerative disease indications. BMC Neurology. 2009. 9.
