GMP Manufacturing
Considering that early stage clinical trials are a key milestone in the development of a drug product, BOC Sciences has been equipped with Innovative and reliable manufacturing techniques. BOC Sciences is a leader in the GMP manufacture of complex APIs and we are committed to continuously ensuring GMP compliance in the daily operations of all our plants. Our advanced cGMP manufacturing facilities enable us to deliver a variety of Phase I-III API manufacturing projects.
Our Services
To make it easier and better for researchers, BOC Sciences provides GMP 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.
- Prior to GMP production, the process outline generated during development is translated into step-by-step instructions in a process log sheet (PRS), and analytical chemistry methods and specification sheets are translated into monographs that describe the analytical work required to control the process
- BOC Sciences' team of highly trained GMP chemists follows these detailed instructions when creating customer materials
- Any deviations are documented through non-conformance reports (NCRs) and non-conformance reports of specifications (OOS) in accordance with our quality procedures
- Corrective actions and preventive action plans (CAPA) can be put in place when needed and are documented through our change control (CC) process
- We implement Constant Quality Control (QC) to test raw materials and then proceeds to be implemented for In-Process testing and finally for Release QC testing
API Synthesis and Process Validation
- Our GMP manufacturing team pays special attention to equipment qualification and process validation, and provides full regulatory support for our GMP API manufacturing customers
- We follow the strictest guidelines, perform the most rigorous testing and execute studies in a timely manner to ensure that your product is of the highest quality
- BOC Sciences can design and execute the required validation programs for each API manufacturing program based on current guidelines and acceptable formats which includes process validation, cleanliness validation, aseptic processing, terminal sterilization, environmental control, IQ/OQ/PQ/PV and utility qualification, statistical analysis and decision analysis
- We can also accelerate your drug development program by integrating process development, cGMP API manufacturing, and finish dose manufacturing at a single location
Figure 1. Process flow diagram for batch pharmaceutical manufacturing of an API. (Gerogiorgis, D. I.; et al)
Manufacturing procedures
Custom synthesis of small molecules APIs is performed in our modern cGMP API production facility
- DOEs to define critical process parameters
- In-house testing, release of raw materials, and packing materials
- Kilo-lab for scalability and robustness demos
- Long-term supply-chain strategies
- Dedicated areas for wet analysis and instrumentation (HPLC, GPLC, and GC)
- Analytical instrumentation
- Stability testing per ICH guidelines
- Pneumatic powder transfer handling system and through IBCs
- High Pressure Manufacturing
- Cryogenic Manufacturing (-78°C)
- Filters
- Driers (RCVD, ANFD, VTD)
- Powder processing areas includes Micronizer, Multi Mill, Co-Mill, Sifter and Homogenizer
Our core strengths
Our innovative method of building integrated GMP and Good Clinical Practice (GCP) programs provides a streamlined, flexible approach to API supply that reflects your clinical study design and timeline.
- Process engineering
- Handle hazardous reactions
- Flow chemistry
- Closed material handling system for solids and solvents
- Single fluid heating/cooling system with operating temperatures at -20°C to +140°C
- Process automation through DCS and PLCs
- Process equipment handling under inert atmosphere
- Cleaning in-place through spray ball
- Flexible modular plant design for quick change overs
- ISO class 8 clean rooms
- Uni-directional material flow
- Separated storage facility for highly-potent compounds
- FM Global-compliant: smoke detectors, sprinklers, fire hydrant systems all over storage areas
- Rapid development of analytical methods to support your early formulation prototype characterization, including assay, purity, and solubility
- Development of stage-appropriate methods to support batch release and stability testing for your Phase I and Phase II drug product manufacturing
- Finalization of analytical methods to support the production of your Phase III, registered and commercial drug products
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 GMP manufacturing at competitive prices for global customers. Personalized and customized services of GMP 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
- Gerogiorgis, D. I.; et al. Continuous pharmaceutical process engineering and economics Investigating technical efficiency, environmental impact and economic viability. Chimica Oggi International Journal of Chemistry & Biotechnology. 2015. 33(6).
