Cell Bank Manufacturing
Pharmacologists design and produce a variety of cell banks to deliver therapeutic cellular products. The production and preservation of cell banks is continually being optimized to ensure the viability, recovery and potency of the cells provided and to ensure product safety. BOC Sciences' thorough understanding of the various stages of the manufacturing process enables to provide our customers with effective cell bank process development services. Our cell banking team ensures product quality and safety at all stages of cell banking production and supports the stability of the final product under long-term cryogenic storage conditions.
Figure 1. Illustration of bioprocess for hPSC MCB manufacturing. (Li, Y.; Ma, T. 2012)
Our Services
To make it easier and better for researchers, BOC Sciences provides cell bank 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 can offer microbial, mammalian and insect cell GMP cell bank manufacturing in accordance with current regulatory guidelines. Master Cell Banks (MCB) are prepared using RCB as starting material while Working Cell Banks (WCB) are prepared from MCBs under defined cell culture conditions for the production of innovative biopharmaceutical or gene therapy applications. Our cell banking manufacturing services include the following:
- RCB generation
- MCB and WCB manufacturing in compliance with GMP standards
- Dedicated clean rooms for the preparation of mammalian and microbial cell banks
- Well control of freezing of cells
- GMP-compliant MCB and WCB storage in liquid nitrogen vapor phase storage systems or in an ultra-low temperature refrigerators
- Round-the-clock facility monitoring
- Flexible shipments to other sites
- Comprehensive cell banking characterization services
Figure 2. Example of different hPSC banks expanded in different growth conditions. (Li, Y.; Ma, T. 2012)
MCB manufacturing
BOC Sciences provides master cell bank characterization and genetic stability studies. The therapeutically produced cells are typically generated through a process that includes gene transfection or transformation, screening for expression, cell expansion and characterization
WCB manufacturing
Working cell banks are prepared from the MCB under defined cell culture conditions. Quality control testing is conducted by DNA analysis techniques to confirm that the MCB and WCB are genetically identical and to ensure that the WCB is free of contaminants
Features of our services
- Principles of good manufacturing practice for therapeutic cell banking including product characterization, batch release testing and so on
- Principles related to environmental control/monitoring of cell production facilities and cell storage environments
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 cell bank manufacturing at competitive prices for global customers. Personalized and customized services of cell bank 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
- Li, Y.; Ma, T. Bioprocessing of Cryopreservation for Large-Scale Banking of Human Pluripotent Stem Cells. Bioresearch Open Access. 2012. 1(5): 205-214.
