cGMP Manufacturing
cGMP stands for Current Good Manufacture Practices. Compared to GMP, cGMP places more emphasis on site management (Current), such as regulating the actions of operators and how to handle emergencies in the manufacturing process. It requires verification throughout the entire production and logistics process. The goal of cGMP is to improve product quality. BOC Sciences combines leading expertise in cGMP manufacturing technology and scale-up with state-of-the-art cGMP facilities to offer industry-leading CGMP manufacturing services.
Figure 1. Schematic illustration of current multi-step cell manufacturing strategies. (Nath, S. C.; Harper, L.; et al. 2020)
Our Services
To make it easier and better for researchers, BOC Sciences provides cGMP 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.
Pre-clinical Manufacturing
Our preclinical manufacturing team provides R&D, engineering and full analytical services
Clinical Manufacturing
BOC Sciences’ clinical manufacturing capabilities cover a wide range of dosage forms including powders, semi-solids, devices, solutions and suspensions
Commercial Manufacturing
Our dedicated team and manufacturing facilities ensure that complex drug products get the care and attention they need to succeed
Key Requirements of Our cGMP Manufacturing
- Facilities and Equipment
At BOC Sciences, facilities and equipment are properly maintained to ensure that the conditions of production are safe and efficient. In addition, we ensure that the SOPs (Standard Operating Procedures) are up to date
- Raw Materials and Products
We provide our customers with a master formula for each drug product that is followed without deviation throughout the manufacturing process. BOC Sciences has introduced a fully digital eQMS to reduce human error and ensures cGMP compliance by automating the document control process
- Employees
Our employees are required to operate every step of the manufacturing process
- Procedures and Processes
Our manufacturing processes and procedures are repeatable, and with our management software module, we can ensure that all of our customers' documents and procedures are up-to-date and cGMP compliant
GMP Facility Highlights
BOC Sciences' state-of-the-art cGMP biologics manufacturing facility is producing clinical supplies for our customers. Our experienced cGMP group is capable of providing bulk biologics development and manufacturing services
- Our facility can handle a variety of sizes and process modes (feed-batch and perfusion), and is designed with unidirectional material and personnel flow and air handling to meet global regulatory requirements for the production of commercial products
- Over 4,000 square meters of cGMP compliant stock solution production area
- Disposable bioreactors and bioprocess platforms for rapid deployment and accelerated production with flexible, scalable processes
- Separate Class C cell inoculation rooms to support cell building and seed recovery under cGMP conditions
- Single-use platforms for culture medium or buffer preparation and storage
- Separate upstream and downstream production areas
- Class D support area for support upstream and downstream cleaning, sterilization, and storage
- On-site WFI (water for injection) generation is integrated with the facility
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 cGMP manufacturing at competitive prices for global customers. Personalized and customized services of cGMP 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
- Nath, S. C.; Harper, L.; et al. Cell-Based Therapy Manufacturing in Stirred Suspension Bioreactor: Thoughts for cGMP Compliance. Frontiers in Bioengineering and Biotechnology. 2020. 8.
