High-Potency APIs (HPAPIs) Manufacturing
Compared to traditional APIs, HPAPI offers greater effectiveness. However, it also presents considerable challenges to its processing process. To meet the growing demand for the production and processing of high potency compounds, BOC Sciences has 30 years of experience in HPAPI development and manufacturing, and our advanced facilities feature specialized containment engineering.
Figure 1. APIs manufacturing using continuous flow chemistry. (Baumann, M.; Baxendale, I. R. 2016)
Our Services
To make it easier and better for researchers, BOC Sciences provides high-potency APIs 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
HPAPI manufacturing process
From early development to commercialization, we are committed to helping our customers design a process that fits their specific requirements while ensuring repeatable quality, safety and efficiency. Our flexible asset suits allows us to easily handle solids, liquids, pyrophoric and other hazardous materials in a wide range of processes such as distillation, cryogenics, hydrogenation and particle sizing.
- Firstly, we carry out a thorough review of all knowledge of the API and intermediates including consultation with appropriate health and safety, toxicology and operational experts
- Then, comparisons are completed with known compounds and additional testing is performed as necessary
- Finally, a full standard SOP and operating instructions are generated based on this thorough review
Our HPAPI capability
- High purity material (HPLC purity >97%)
- HPAPI capacity that can produce products ranging from 0.5 kg to 50 kg
- 100 mg samples available
- Validated analytical methods
- Chromatography-free. Timely in-house cGMP process
- Supply chain risk reduction - stock readily available
Cytotoxic drug safety
We conduct each project with a thorough toxicological assessment to develop a customized containment strategy that is both safe and pragmatic. As more clinical data becomes available, we adjust our approach throughout the project to ensure the best balance between safety and efficiency. Our analytical and manufacturing plants are equipped with state-of-the-art technology to reduce the significant inherent risks that pose to operators and patients. Our goal is to eliminate the risk of manual intervention with your drug products. In addition, operations beyond cGMP requirements to prevent cross-contamination are our standard.
- Special equipment requirements
- Defined facility resources for the project
- Fully understand the safety information of your compound to ensure undisrupted progress for your project
Instruments
- Equipped with containment technology, controls and capabilities for safe handling of highly-potent APIs
- Separate QC lab for testing
- An independent storage facility for intermediates/HPAPI
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 high-potency APIs (HPAPIs) manufacturing at competitive prices for global customers. Personalized and customized services of high-potency APIs (HPAPIs) 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
- Baumann, M.; Baxendale, I. R. The synthesis of active pharmaceutical ingredients (APIs) using continuous flow chemistry. Blstn Journal of Organic Chemistry. 2016. 47(12): 1194.
