Process Optimization
Process optimization lays the foundation for scale-up and plays an important role in complying with current cGMP. Process optimization determines what is needed to scale up. The ultimate goal is to obtain better yields of chemicals and eliminate problems that may affect successful commercialization. Successful optimization of process can help customers get the right results the first time, which can save money and help you get to kilo labs faster with the right process. At BOC Sciences, our process department has employed QbD principles in API process development, striving to select the best route that is optimal for our customers. By optimize the API production process, we can reduce manufacturing risk and improve product quality and production efficiency. BOC Sciences is able to optimize and determine important process parameters, post-treatment methods, purification methods, impurity profile studies, process risk assessment and control, and process safety evaluation.
Benefits of process optimization
- Eliminate process steps
- Increase yields
- Reduce cycle time
- Produce higher quality products
- Reduce costs
Figure 1. The three stages of process validation. (Hulbert, M.H., et al. 2008)
Our Services
To make it easier and better for researchers, BOC Sciences provides process optimization 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. BOC Sciences has established a professional process safety team dedicated to process safety assessment in the chemical and pharmaceutical industry
- Thoroughly study critical process parameters (CPPs) including temperature, concentration, time of reaction, crystallization, stirring rate, etc
- Evaluate the thermal stability of samples by measuring the sample onset decomposition temperature, heat of fraction, and temperature and pressure changes during sample decomposition
- Measure the reaction heat, exothermic rate, heat accumulation, reaction outgassing rate, etc
- Perform safety analysis of the process
- Determine the direction of process optimization and adjustment
- Professional reaction heat risk assessment report
Figure 2. Quality requirements and elements. (Hulbert, M.H., et al. 2008)
Key Equipment
Our team is skilled in operating multiple tools to develop robust, safe manufacturing processes and ensure safe manufacturing of APIs:
Calorimeter
We apply it in the reaction characterization to help determine key process parameters including reaction enthalpy, thermal conversion rates, maximum temperature of the synthesis reaction (MTSR), ΔTad (adiabatic temperature rise), gas evolution and others
Differential scanning calorimetry (DSC)
DSC is used to measure the enthalpies associated with transitions and chemical reactions and determines the temperature at which these processes occur
Accelerated rate calorimetry (ARC)
ARC is applied to evaluate reaction calorimetry, secondary reactions of raw materials, intermediates and products (thermal stability assessment)
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 optimization at competitive prices for global customers. Personalized and customized services of process optimization 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
- Hulbert, M.H.; et al. Risk Management in the Pharmaceutical Product Development Process. Journal of Pharmaceutical Innovation. 2008. 3(4): 227-248.
