Pilot Scale-up
Pilot scale-up is a necessary step in the process of drug development to production, and an effective measure to reduce the risk of industrialization. Pilot scale-up is a small-scale production simulation test, which is based on small-scale experiments to study the feasible solution for industrialization. Scientists perform pilot scale-up to study the chemical reaction conditions of each step in a certain scale of device, solve the problems that cannot be found in the laboratory, and provide the design basis for industrialization production. In general, pilot scale-up is an important transition stage towards industrial production. BOC Sciences' pilot-scale drug product specialists are dedicated to the manufacture of liquid and lyophilized drug products in compliance with cGMP.
Tasks of the pilot scale-up
- Check whether the process route provided by the laboratory has special requirements for process equipment, conditions, raw materials, etc. during pilot scale up and whether it is suitable for industrial production
- Verify the reasonableness of the pilot process
- Further evaluate and improve the process conditions, and obtain basic and stable data for each step of the reaction and unit operation
- Selection of materials and types of equipment
- Determine the requirements for heat and mass transfer for each reaction step The effect of dosing method and dosing rate on the reaction in exothermic reaction.
- Determine the physical properties and chemical constants of raw materials and intermediates
- Determine raw material costs, operating times and production cycles
- Optimize the process flow of the entire synthesis route and the process protocols for each unit operation
Figure 1. Scale-up bioprocess development for valinomycin production. (Jian, L.; Jennifer, J. et al. 2015)
Our Services
To make it easier and better for researchers, BOC Sciences provides pilot 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.
- Aiming to maintain product quality and robustness, a team of dedicated formulation and process experts carry out the identification of critical process parameters (CPPs) and critical quality attributes (CQAs)
- Quality by Design (QbD) principles and Design of Experiments (DoE) strategies: We help our customers build robustness and quality into their final formulations through a systematic understanding of the product and process
- Aseptic drug products manufacturing includes the selection and qualification of the primary packaging materials, process development
- Manufacturing of biologics as liquid and lyophilized products under cGMP-compliant conditions
- The drug products batches are available for toxicology and stability studies as well as clinical studies
Upstream process
- Cell banking
- Media pretreatment
Downstream process
- Buffer preparation
- Initial purification and final purification
Filling and Finishing
- Ingredient preparation
- Aseptic filling and capping
- Lyophilizaton
Figure 2. Schematic representation of the pilot-scale set-up. (Guven, H.; Ersahin, M. E. et al. 2017)
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 pilot scale-up at competitive prices for global customers. Personalized and customized services of pilot 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!
References
- Jian, L.; Jennifer, J. et al. Scale-up bioprocess development for production of the antibiotic valinomycin in Escherichia coli based on consistent fed-batch cultivations. Microbial Cell Factories. 2015. 14(83).
- Guven, H.; Ersahin, M. E. et al. Effect of Hydraulic Retention Time on the Performance of High-Rate Activated Sludge System: a Pilot-Scale Study. Water, Air, and Soil Pollution. 2017. 228(11): 417.1-417.10.
