API Manufacturing
APIs manufacturing is a crucial step in which APIs are manufactured from raw materials through chemical and physical ways. Depending on the complexity of the molecule, the synthesis of APIs may require multi-step complex chemistry utilizing a range of novel techniques. Nowadays, the development of small molecule demands greater efficiency in the production of APIs. As a leading manufacturer of small molecule APIs, combined with the scientific and engineering expertise of our team. In addition, our facilities are equipped with state-of-the-art production equipment to provide manufacturing support for a wide range of temperature, pressure, vacuum and other technical requirements.
Figure 1. A conceptual integrated continuous manufacturing process. (Sau, L.; Thomas, F. et al. 2015)
Our Services
To make it easier and better for researchers, BOC Sciences provides 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 has built several API technology platforms and our track record includes successful delivery of multiple complex APIs, some with greater than 20 linear steps. Chemistry capabilities include pharmaceutical crystallization, synthesis of highly potent compounds, flow chemistry, biocatalysis, etc
Preclinical research and development
We offer a wide range of R&D services for small molecule APIs using state-of-the-art chemical technologies. For robust and efficient process qualification for scale-up. Our API development process utilizes a diversity of modern tools such as automated workstations, statistical software and reaction calorimetry. BOC Sciences is committed to providing the following services: small molecule API process development and technology transfer in early phase, analytical and testing services including impurity identification and characterization of API products and intermediates, and non-GMP manufacturing. Our professional teams can provide cost-competitive manufacturing on an industrial scale by optimizing chemical processes, utilizing advanced PAT and minimizing unit operations, supported by specialized quality control and quality assurance expertise
At BOC Sciences, our phase I-III small molecule API manufacturing and development services enable to support your molecules throughout the whole clinical process. Our chemists can apply a phase-appropriate approach to ensure that each stage of development is fit for purpose. We are experts in small-scale API manufacturing and can design the most strategic pathway for your project. We have a proven track record of meeting the unique requirements of clinical phase projects and offer a flexible approach that is suitable for today's increasingly complex APIs. BOC Sciences' laboratories are developed to support all phases of clinical trials. From quality assurance to GMP manufacturing and analytical chemistry support to stability testing, we are focused on optimizing your API supply by minimizing risk and accelerating timelines
With strict adherence to the Quality by Design (QbD) concepts and a focus on continuous improvement according to ICH guidelines, BOC Sciences helps your project transition seamlessly from lab scale to pilot and commercial scale. Our commercial manufacturing is completed in a strict cGMP environment with the application of state-of-the-art equipment and raw materials from a trusted and timely supply chains. Moreover, we support different batch sizes ranging from 0.1 kg to several hundred kg, meeting both small and large commercial needs
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 manufacturing at competitive prices for global customers. Personalized and customized services of 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
- Sau, L.; Thomas, F. et al. Modernizing Pharmaceutical Manufacturing: from Batch to Continuous Production. Journal of Pharmaceutical Innovation. 2015.
