Phase I-III API Manufacturing
BOC Sciences has introduced a phase-appropriate approach to ensure that each phase of development is fit for purpose. Our team of chemists are experts in small-scale drug manufacturing and can quickly establish the most strategic pathway for your project. We have extensive experience in meeting the unique requirements of clinical stage projects, offering a variety of flexible approaches to API manufacturing for different projects. Our experience in hundreds of clinical phase programs at all stages of the drug development pipeline gives us unique goals and challenges for manufacturing support in clinical development. We have a in-dept understanding of which approaches prove most effective at each stage of the drug development while ensuring appropriate quality and compliance.
Benefits of our phase I-III API manufacturing
- Optimize your drug supply
- Minimize risk
- Accelerate timelines
Figure 1. Main steps of drug production process for clinical study. (Harada, L. M.; AMD, S. 2016)
Our Services
To make it easier and better for researchers, BOC Sciences provides phase I-III API manufacturing 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 phase I-III API manufacturing services for your small-molecule APIs to meet specific requirements, and we are capable of performing the following preclinical research based on the needs of the project.
BOC Sciences is equipped with state-of-the-art laboratories to support all phases of clinical trials
- Efficient project approach: Manufacturing drug candidates for pre-clinical and phase I clinical studies, and providing support capabilities such as dedicated rapid development and scale-up groups and isolation teams
- Process qualification/validation
- Seamless transition from lab to plant without the need for technology transfer to another companies
- Multiple GMP manufacturing sites capable of supporting a wide range of manufacturing sizes from grams to metric tons
- Quality assurance: You can rely on BOC Sciences' deep regulatory experience to assist you through each phase of the clinical trial process
- Analytical chemistry support and stability testing
- Supply chain development: Extensive network of suppliers capable of supporting increasing demand as drug candidates progress through the clinical pipeline
Explore our phase I-III API manufacturing capabilities
Figure 2. Flowchart of a general clinical trial supply chain. (Harada, L. M.; AMD, S. 2016)
Our team of highly trained GMP chemists follow optimized processes when making customer materials, while our development team is available to advise during those difficult stages. Corrective actions and preventive action plans are put in place quickly when required and are documented through our change control process
Our phase I-III small molecule API analytical support includes reference standard characterization, forced degradation, and method validation. In the early stages, the primary API purity methodology will be validated as a standard. In addition, we have introduced a fully characterized reference standard of the API to support HPLC assay analysis. Further validation of the final API method, including all specified impurities and all methods used in the GMP phase of synthesis, is performed in the later stage of development
During the development phase of the project, important information of API stability will be gained, which will inform the ICH stability study. BOC Sciences conducts formal ICH studies as soon as materials are available from the developed synthesis
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 phase I-III API manufacturing at competitive prices for global customers. Personalized and customized services of phase I-III API manufacturing 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
- Harada, L. M.; AMD, S. PLANNING PROCESS OF PILOT BATCH PRODUCTION OF AN INNOVATIVE DRUG FOR CLINICAL TRIAL IN A PHARMACEUTICAL INDUSTRY. Brazilian Journal of Operations & Production Management. 2016. 13(4): 462-471.
