Analytical Services
We offer complete solutions for analytical development and validation at the phase I-III API manufacturing stage to streamline and simplify your drug development workflow. From fit-for-purpose validation and commercial support to gap analysis and remediation programs to meet CMC regulatory requirements. In addition, BOC Sciences is committed to continually investing in new technologies to give our customers an edge. Our experienced and highly skilled analysts are dedicated to providing our clients with reliable analytical solutions to support a variety of API development programs.
Figure 1. Engineering view of pharmaceutical development. (Rantanen, J.; Khinast, J. 2015)
Our Services
To make it easier and better for researchers, BOC Sciences provides analytical services 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.
We understand your analytical objectives throughout the drug development process and work with you to ensure that appropriate methodologies are available at all stages:
- Early handling protocols for your compound
- Analytical methods to support your formulation prototype characterization including assay, purity and dissolution
- Method optimization to ensure robustness
- Further analytical method optimization to support cGMP process intensification
Candidate screening
Our material science experts are capable of rapidly characterizing API properties in order to support the selection of lead drug product formats for clinical evaluation:
- Physicochemical properties
- Solid form definition and analysis
- Excipient compatibility testing
- Crystalline solid state testing
- Aqueous and solvent solubility
Analytical development
- 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
Figure 2. Schematic illustration of various modes of process analysis. (Rantanen, J.; Khinast, J. 2015)
Analytical testing
We have extensive experience in the testing of drug products, and our capabilities include:
- Purity, dissolution and physical characterization
- ICH stability testing of late stage drug products
- Specialists at the microbial analysis of radiolabelled compounds, cytotoxic & high potency compounds and controlled substances
Advanced instrumentation
BOC Sciences has combined the expertise of our team with state-of-the-art instrumentation. Aiming to provide accurate, reproducible results, we introduce a range of advanced technologies, including rapid resolution/high resolution chromatography, HPLC/UPLC, GC/MS, LC/MS/MS, LC-Q-TOF, IC, DSC and TGA, ICP-MS/ICP-OES, and others
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 analytical services at competitive prices for global customers. Personalized and customized analytical services 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
- Rantanen, J.; Khinast, J. The Future of Pharmaceutical Manufacturing Sciences. Journal of Pharmaceutical Sciences. 2015. 104(11): 3612-3638.
