API Development
At BOC Sciences, we have a wide range of API development capabilities, from route scouting and design, to process optimization and full validation support, including Quality by Design (QbD). In addition, with industry-leading expertise and a team of experienced scientists, BOC Sciences has helped our clients develop more than 1,000 Active Pharmaceutical Ingredients (APIs) and advanced intermediates, of which more than 200 New Chemical Entities (NCEs) have been approved in the global marketplace. We operate with rigorous precision and speed, phase-appropriate approach to drug development by using a ‘fit-for-purpose’ strategy.
Figure 1. Map of factors of API affecting dispersible tablet formulation approaches. (Gerrard, S. E.; et al. 2019)
Our Services
To make it easier and better for researchers, BOC Sciences provides API 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.
Route Design and Scouting
Route scout is of utmost importance in the early development stage. Based on our expertise in complex chemistry, BOC Sciences has accumulated extensive experience in compound synthesis and scale-up. We have prepared a unique library of chemical information on compounds and related reactions to help chemists quickly design process routes in the early stages of process research of APIs and intermediates.
High-quality process development
Reliable and robust processes are the foundation for delivering high quality products. Our team is dedicated to identifying and developing customized processes to meet your project requirements while ensuring the quality, safety, efficiency and sustainability of the development process.
- ‘Fit for purpose’ process development
- Control strategy development for starting materials (RSMs), advanced intermediates and APIs
- Final process development for commercial production and supply
- Support Process Analysis Technology (PAT) to guide process development, such as on-line IR, on-line HPLC, FBRM, etc
- Application of Quality by Design (QbD) principles to guide process development, such as design space studies by using Statistical Design of Experiments (DoE) tools
Process optimization and validation
In order to deliver the top-quality product, BOC Sciences performs detailed optimization within the project scope. Our team has extensive experience in scaling up most types of organic reactions. Aiming to obtain robust processes, reduce costs and increase output, we have a dedicated chemical engineering team that works with R&D and QA teams to perform process validation.
- Process development and optimization driven by optimization of key influencing factors such as quality, efficiency, cost and Process Mass Intensity (PMI)
- High throughput screening and optimization of high-cost catalysts
- Process optimization by One-Variable-At-a-Time (OVAT)
State-of-the-art instrumentation
- Fast Resolution Chromatography
- HPLC: Waters, Agilent, Dionex
- High resolution chromatography
- GC/MS: Agilent
- GC: direct injection and head space capability
- LC/MS: MSD with APCI & ESI
- HIAC
- IC (conductivity and ECD)
- DSC and TGA
- Dissolution (apparatuses I, II, VI)
- UPLC
- LC/MS/MS: Quadrupole, triple quadrupole and time-of-flight of mass spectrometers with APCI and ESI
- Chromatographic data processor
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 API development at competitive prices for global customers. Personalized and customized services of API 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
- Gerrard, S. E.; et al. Innovations in Pediatric Drug Formulations and Administration Technologies for Low Resource Settings. Pharmaceutics. 2019. 11(10): 518.
