Process Scale-up
In the basic description of the scaling-up process, large-scale reactors, such as those found in manufacturing and pilot plants, typically behave adiabatically, losing little heat to the surroundings. This is very different from smaller, laboratory-based vessels, which lose proportionally more heat. Conducting all pharmaceutical manufacturing processes in a safe manner is essential. BOC Sciences is equipped with a diversity of advanced instrument, including RC1e, DSC, RSC, ARC, and TGA, and has a dedicated process safety team to collect comprehensive data and support the entire safety process analysis. We are capable of identifying potential safety risks during the scale-up processes, and helping chemists optimize and demonstrate process robustness. At BOC Sciences, a comprehensive safety assessment typically begins once a project is accepted and run parallel to process development activities.
Figure 1. Scale-up process and optimization steps to establish a high-throughput approach of all bioanalytical assays. (Burckhardt, B. B.; Stephanie, L. 2015)
Our Services
To make it easier and better for researchers, BOC Sciences provides process scale-up 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. We have established various compliant laboratories to collect, analyze process data to optimize the process to ensure that there is no safety risk in the process scale-up
- With years of experience in APIs development, BOC Sciences can offer a range of supports to meet any process optimization need with the aim of carrying out the scale-up safely and successfully
- Our laboratory-based process assessments fully consider plant-level hazards, and we employ various tools to mitigate worst-case impacts
- We can fully simulate a number of risk scenarios under manufacturing conditions in the laboratory to ensure that appropriate safety measures are planned and implemented prior to manufacturing
- If the manufacturing facility cannot handle the worst-case scenario, we modify the process so that the existing system can at least contain the worst-case scenario
- Our teams also expand the breadth of scale-up testing to be able to simulate different reaction scenarios
Key facilities
Our team is skilled in operating multiple tools to develop robust, safe manufacturing processes and ensure safe manufacturing of APIs:
- The process safety laboratory is accredited by the China National Accreditation Service for Conformity Assessment (CNAS)
- The accreditation of the process safety laboratory recognizes BOC Sciences’ capabilities and qualifications to serve process safety assessments in the field of pharmaceutical process development and manufacturing
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 process scale-up at competitive prices for global customers. Personalized and customized services of process scale-up 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
- Burckhardt, B. B.; Stephanie, L. Sample Preparation and Extraction in Small Sample Volumes Suitable for Pediatric Clinical Studies: Challenges, Advances, and Experiences of a Bioanalytical HPLC-MS/MS Method Validation Using Enalapril and Enalaprilat. International Journal of Analytical Chemistry. 2015: 796249.
