Commercial API Manufacturing
BOC Sciences' advanced facilities offer commercial API manufacturing services, allowing us to support your small molecule APIs throughout the entire product lifecycle. We have a continuously updated state-of-the-art facility for the production of market-scale APIs under cGMP. With years of experience in APIs development, BOC Sciences can offer a range of supports to meet any commercial API manufacturing need.
Figure 1. Examples of commercial flow setups currently available to researchers and some individual commercial components that can enable researchers create their own setup. (Rogers, L.; Jensen, K, F. 2022)
Our Services
To make it easier and better for researchers, BOC Sciences provides commercial 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.
BOC Sciences provides customized product development and cGMP commercial-scale manufacturing services for APIs and advanced intermediates. Our commercial-scale API manufacturing is developed based on three areas:
- Integrated services from phase I through to commercialization
- Late-stage transfer as a means to accelerate access to market and/or reliable commercial supply
- Second sourcing to better ensure security of supply
Flexible approaches to API manufacturing
Throughout the development cycle and into commercial-scale supply, we focus on flexible supply solutions tailored to your specific needs. BOC Sciences has extensive capabilities and facilities to support this flexible approach to API production. Our API commercial production facilities are equipped with state-of-the-art equipment, combined with years of process optimization. Moreover, the flexibility offered by the multi-purpose plant and phase-appropriate processing can meet customer requirements for increasingly complex chemistry, more specialized target product profiles, integrated API and drug product solutions, and accelerated timelines
Explore our commercial API manufacturing capabilities
Quality by Design (QbD) for drugs is a systematic approach to development where statistical optimization through Design of Experiments (DoE) is the primary tool used to optimize and understand the manufacturing process. We have introduced Qbd strategies to reduce the occurrence of batch failures, provide effective control, and bring greater time and cost efficiencies
Process validation from the process design stage to commercial API production is used to demonstrate that a process can consistently deliver a quality product. Our team of experts uses process validation to demonstrate that a process is controlled and capable of reproducible commercial production
Figure 2. Categorization of potential controls and testing levels available for control strategies in pharmaceutical manufacturin. (Rogers, L.; Jensen, K, F. 2022)
Commercial capabilities and advanced technologies
- Contained environments (isolation, solids handling)
- Low-temperature modules
- Solvent recovery plants
- Reactor sizes from 160-16000 L
- Low (-90 ℃) to high (650 ℃) temperature reactions
- High pressure reactions (80 atm)
- Back-integrated (diketene, ketene, HCN, acetylene)
- On-site process development services and analytical support
We are continuously making investments in capacity and technology, including:
- Product-specific equipment that minimizes cross-contamination
- Ability to quickly resolve production issues and ensure seamless technology transfers
- Products are manufactured under full-GMP conditions from defined starting materials to finished APIs
- ICH stability storage and testing
- Worldwide product registration
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 commercial API manufacturing at competitive prices for global customers. Personalized and customized services of commercial 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
- Rogers, L.; Jensen, K, F. Continuous manufacturing-the Green Chemistry promise?. Royal Society of Chemistry. 2022.
