Commercial Manufacturing
The development of biopharmaceutical products need to achieve high quality large-scale commercial production. How to conduct efficient commercial manufacturing must be taken into consideration in the successful product launch. BOC Sciences has established a GMP-compliant quality system to provide complete services for biologics manufacturing to our customers worldwide. With our advanced commercial manufacturing platform and project-experienced team, we can minimize technology transfer time and facilitate our customers' new drug development.
Capabilities
- Aseptic manufacturing
BOC Sciences is equipped with ISO 5 sets for aseptic processing, including filling of vials, ophthalmic bottles, syringes, cartridges and injector devices. We also have fully enclosed steam-in-place manufacturing capabilities
- Lyophilization
Our commercial lyophilizers can offer clean-in-place capabilities for aseptic processing which builds upon our existing R&D and clinical lyophilization capabilities
- Particle size reduction
We are a leader in nano-milling (wet, dry and aseptic) and microfluidization technologies. We are able to perform nano-milling under aseptic conditions at commercial scale
- Fill-finish operations
BOC Sciences produces biologics such as proteins, peptides and oligonucleotides under sterile and non-sterile conditions, and have filling lines for a variety of containers including vials, syringes, cartridges and bottles
Figure 1. Clinical and process development flowchart. (Shukla, A. A.; ThoMmes, J. 2010)
Our Services
To make it easier and better for researchers, BOC Sciences provides commercial 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.
- Flexibility
We utilize our flexible cleanroom space to support both simple and complex processes for small to medium commercial batch sizes production, and we are able to ensure that our customers have a viable facility for commercial production
- Flexible Cleanroom Space
We offer flexible, purpose-built cleanroom suite space for your commercial manufacturing projects
- Small to medium scale commercial manufacturing of batch, sterile or non-sterile pharmaceutical products
We have flexible filling capabilities for filling biological drug products into vials, syringes, cartridges and bottles
GMP Facility Highlights
With a focus on commercial manufacturing of a range of dosage forms, including sterile and complex formulations as well as high-value, lower batch size products, we have the ability to fulfill our customers' diverse needs for commercial manufacturing of lower batch size drug products. BOC Sciences' GMP commercial manufacturing facilities feature purpose-built infrastructure and highly specialized staff with decades of experience to ensure the success of your drug product.
- We offer flexible and versatile cleanroom space for the commercial manufacturing of antibodies and recombinant proteins at different scales in fed-batch or perfusion culture
- We have a well-established quality system that provides appropriate risk control and cross-contamination prevention measures to meet global regulatory requirements
- BOC Sciences has introduced single-use consumables and flexible modular production mode to improve the equipment turnaround, thus helping customers achieve continuous and efficient production scheduling and reduce production costs
- Our experts are able to ensure access to and supply of raw materials, mitigate associated risks (EHS, regulatory, sustainability, etc.), and establish a strong integration system
- BOC Sciences' state-of-the-art facilities are GMP regularly inspected and operate under a single quality system, ensuring that improvements made at one facility can be rapidly scaled up to all
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 manufacturing at competitive prices for global customers. Personalized and customized services of commercial 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
- Shukla, A. A.; ThoMmes, J. Recent advances in large-scale production of monoclonal antibodies and related proteins. Trends in Biotechnology. 2010. 28(5): 253-261.
