Clinical Manufacturing
Clinical trial is a critical stage in drug development. A reliable result of clinical trial ensures a stable supply of high quality clinical trial drugs, which is essential for the successful launch of a biologic product. BOC Sciences has an integrated one-stop manufacturing service capability, and our experienced cross-functional project team is able to design a comprehensive and flexible workflow that fully meets the customer's process requirements and can be manufactured according to the GMP system. Our clinical manufacturing team has successfully participated in hundreds of clinical stage project collaborations, we possess extensive experience in manufacturing support for clinical development. In addition, our experts have established robust manufacturing processes for starting materials across a range of indications to support different clinical programs. BOC Sciences knows exactly what is needed to support early clinical (Phase 1/2a) and late clinical (Phase 2b/3) programs.
Clinical Manufacturing Features
- Manufacturing scale and standard
- Strictly compliance to GMP requirements
- Meet the drug demand for a global clinical trials
- Flexible production process, ensure the rapid switching of manufacturing lines
- Project time and cost
Figure 1. Clinical and process development flowchart. (Feng, L.; Shen, A. et al. 2013)
Our Services
To make it easier and better for researchers, BOC Sciences provides clinical 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 offers extensive clinical trial manufacturing capabilities that complement our formulation and pre-clinical manufacturing expertise. Our integrated approach provides a smooth transition from the bench to production.
- We manufacture drug candidates for pre-clinical and phase I clinical studies such as a dedicated rapid development and scale-up teams and isolation teams
- Comprehensive support for the progress of drug candidates through each phase of clinical manufacturing
- Process development/analysis appropriate to each phase
- Process qualification/validation
- Supply chain development
- Quality control
- Comprehensive drug registration and regulatory dossier support
- Technology transfer: Enables to achieve near 100% replication of processes, thus ensuring the successful of one-time delivery
- Extensive supplier network capable of supporting increased demand as drug candidates progress through the clinical pipeline
- Multiple GMP manufacturing sites capable of supporting manufacturing at a wide range of scales from grams to metric tons
Figure 2. Manufacturing schema. (Jin, J.; Gkitsas, N. et al. 2018)
Independent Functional Areas
- Process development lab
- Analytical development lab
- Quality control lab
- Clinical drug substance manufacturing area
- Clinical drug product manufacturing area
- Raw material and product warehouse
- Engineering center
- Office and staff amenities
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 clinical Manufacturing at competitive prices for global customers. Personalized and customized services of clinical 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!
References
- Feng, L.; Shen, A. et al. Cell Culture Processes in Monoclonal Antibody Production. American Cancer Society. 2013. 2(5): 466-477.
- Jin, J.; Gkitsas, N. et al. Enhanced clinical-scale manufacturing of TCR transduced T-cells using closed culture system modules. Journal of Translational Medicine. 2018. 16(1): 13.
